Controversial Topics

5 PITFALLS OF INFERTILITY TREATMENT

Infertility is defined as the inability to conceive after one year of unprotected well-timed intercourse. This does not apply if the woman is over 35 and has been trying unsuccessfully for 6 months or where either partner has a known history of fertility related problems. Please do not feel alone. Difficulty with conception effects more than 10 million people in this country or 1 out of every 6 couples and is shared by women and men. Approximately 50% of the problem can be traced to the woman, 50% to the man, and in up to 35% of the cases, there is more than one reason why the couple cannot conceive. Although this definition is meant to be used as a guideline, rigid adherence to the definition can and is a disservice to any couple who wants to have a baby. If the woman has known fertility related issues like a previous history of a ruptured appendix, old pelvic inflammatory disease (PID), a procedure on her cervix for an abnormal PAP like cryosurgery, cautery, LEEP or cervical conization, a history of endometriosis, an ovarian cyst, fibroid surgery, or any previous pelvic surgery like a laparoscopy or laparotomy, any previous D&C for irregular bleeding or a termination of a pregnancy, or a history of irregular periods; and in the case of the male, a history of a varicocele, a history of undescended testicles, the use of marijuana or alcohol, a history of infections that effect the testicles (mumps), any trauma and/or surgery to the testicles, and problems with ejaculation or getting an erection, the couple should be evaluated as soon as they plan on starting a family. Valuable time can be lost if evaluation and treatment is delayed. Seeking help is normal and it is nothing to be ashamed about. Difficulty in conceiving, in almost all circumstances, is related to an underlying medical problem, and like most other medical problems, can be diagnosed and successfully treated. When seeking care, there are 5 things you need to know before starting treatment.

1. Make sure that your doctor is an expert and has had specialized training in reproductive endocrinology and infertility. Although gynecologists are excellent physicians, their expertise lies in a different area. Many times, a woman will spend too much time at her GYN's office because she has had a long relationship and “is comfortable”, she does not want to hurt their feelings, she is told to “start doing basal body temperature charts” and/or “try for another 6 months”, or “not to worry” or “you are too young or too old” to be thinking about having children. Because most OB/GYNs are busy, they do not have the time that is needed and desired to spend with you; and many times they are limited in their treatment options. This can lead to increased stress, frustration, anger and time lost and delay important evaluation and treatment.
   
   
2. Once you decide to seek treatment, don't necessarily go to the clinic that is bigger or that is closest to where you live or work, but find one that not only has a reputation of excellent results but one that “will listen to you” without bias, be non-judgmental and embraces all patients, regardless of age, martial status and gender preference. Be careful of advertising like “100% money back guarantee” or being the “biggest”. Like many things, “bigger is not necessarily better”. ACFS gives all of our patients individual and personalized attention, care that, many times, is not possible in larger clinics. If you are comfortable, talk with friends or acquaintances, to find out about their experience and where that “best clinic” is. Patient referrals are generally the best because they have already had an experience with one or more clinics. It is generally one where you “feel comfortable” and have a sense that “you are in the right place” and the clinic “has your best interests” in mind. One that is more interested in you than in their statistics. Be careful of clinics that make “wild claims” that seem unrealistic to you and sayings like “trusted doctors”.
   
   
3. Make sure that you are given the option to do the entire work-up, including controversial testing. Up to 35% of couples have more than one reason for why they are not conceiving. One of the biggest mistakes that is made, is once a problem is identified, the rest of the work-up is not completed, many times overlooking a less but equally important problem; and therefore possibly preventing treatment of the initial problem to be successful. As an example, many clinics do not test for antiphospholipid antibodies unless you have a history of repeated pregnancy loss, in which case, you may test positive for these antibodies. The argument is that fertile women can also test positive for APA and yet have no problems with conception or carrying a pregnancy to term. This is true, although, almost all programs will not do the test until after you have 2 or more pregnancy losses. Why wait until you have 2 documented pregnancy losses before doing the test? ACFS believes it is better to be proactive than reactive; not to mention the emotional and physical trauma of losing 2 or more pregnancies that possibly could have been prevented. The other mistake that is made very often is just because a woman is young, she is not taken as seriously, and a complete work-up is not done, let alone offered. ACFS believes that a complete work-up should be discussed with every patient, regardless of their age or circumstances, and than they should be given the option of whether or not they want to do the entire work-up or only parts of it. It should always be the couple's choice; and by not choosing to do the complete work-up, they are aware of the possible risks of overlooking something that may interfere with their treatment being successful.
   
   
4. Once the work-up is completed, make sure that the clinic gives you all your treatment options, from conservative to aggressive and it is done unbiasedly. Once you are clear on the pros and cons of each one of your choices than you should choose the option that is best for you, not the clinic. Many times, a woman, who is having difficulty conceiving, as the first step is automatically put on Clomid, which is an ovulatory medication used for irregular cycles, even though her cycles are regular. Clomid can have several side effects, including interfering with cervical mucus production and/or the preparation of the lining of the uterus. So, rather than improving your fertility, it may actually decrease it. Even if you are young, it is your choice to be conservative or aggressive. You need to feel that you are being taken seriously, no matter what your age is. A woman in her 20's has the same feelings and desires as a woman in her 40's, the only difference is that the woman in her 20's has a bit more time. With a woman in her late 30's to early 40's, although conservative treatment could work, it should be her choice as to whether or not she wants to be aggressive. A clinic needs to listen and honor her right to choose.
   
   
5. From the beginning, a program should be listening to what you want. You should never have a sense that you are being “talked into or out of something.” For example, even though you would like to attempt pregnancy using your own eggs, some programs will try to “talk you into” using donor eggs, stating very low statistics based on “your age” or the fact that you have an “elevated FSH” level. Make sure that their motivation is about “you” and not their “statistics”. Although, women who are older or who have elevated FSH levels, statistically have a decreased chance of conception, ACFS and others in the country, have had good success with these patients. As a matter of fact, at ACFS, we have found very little to no relationship between FSH levels and pregnancy, only between FSH and age. Also, who is to say that an older woman is not “reproductively young” for her age; whereas, a younger woman is “reproductively old” for hers? ACFS rarely will tell a couple what to do and, is a strong advocate of a woman's right to choose her treatment options, once she is fully informed of all her choices.
   
   

WOMEN WITH ELEVATED FSH LEVELS CAN STILL ACHIEVE PREGNANCY

“I understand that my day 2-3 FSH level is elevated”. FSH is a protein hormone produced by the pituitary gland and is responsible for the stimulation of ovarian follicle development and the production of eggs. There are several schools of thought in the literature concerning an elevated FSH level. Initially, an elevated FSH level was thought to indicate decrease ovarian reserve and increased ovarian resistance resulting in poor ovarian response to stimulation with fertility medication and subsequently poor follicular (egg) response rates and ultimately poor pregnancy rates. Most clinics believe in this school of thought and will cancel your cycle and recommend donor eggs as your only option, quoting poor response rates and very low pregnancy rates. Even if you want to attempt pregnancy with your own eggs, they will not try.

The second school of thought states that if you repeat the FSH levels and they are lower, then that is a better sign, but still an indicator of decreased ovarian function and subsequently decreased pregnancy outcome. Again, most clinics will not give you the chance to attempt pregnancy using your own eggs.

The third school of thought states that there is little relationship between elevated FSH levels and pregnancy and that that an elevated FSH level is not an accurate predictor of pregnancy outcome and is by no means a recommendation for the use of donor eggs.

Arizona Center for Fertility Studies embraces the third school of thought and actually has found little relationship between elevated FSH levels and pregnancy results. The only relationship that we have found is between elevated FSH levels and age. In other words, if you are reproductively young, there is no reason not to proceed using your own eggs. If on the other hand, you are older reproductively and have an elevated FSH level, it might, but not necessarily, indicate that you may have a decreased response to stimulation and thus have decreased pregnancy rates. Some women are just low responders. That means that they just do not produce a lot of eggs but the ones they make can still be excellent. At ACFS, we have had many examples of patients, young and older, with elevated FSH levels who went on to have not only successful stimulation cycles but also good pregnancy outcomes. We are currently putting together a paper for publication looking at all patients, regardless of their age, with an elevated FSH of 15 or greater; showing pregnancy rates of around 34%.

If you have an elevated FSH level and have had a poor response to ovarian stimulation, then there is always the option of considering donor eggs. It is the experience at ACFS that an elevated FSH level is of little value in predicting pregnancy outcome and it is our strong recommendation and experience that you attempt pregnancy using our own eggs. You should however, understand that the stimulation response may not be successful and you may not achieve a successful outcome; but you should always have the choice. This could, in retrospect, be due to the elevated FSH level or a number of other possibilities, all of which need to be evaluated for and ruled out.

IVF vs. TUBAL REVERSALS - WHICH IS BEST?

Mostly, if not all the time, fertility clinics will try to talk a patient out of a reversal of sterilization, trying to convince them that In-Vitro Fertilization is their better choice. This is usually done by “scaring” them about the risks of surgery and anesthesia, the “low success rates with a reversal of sterilization”, the increased risk of an ectopic or tubal pregnancy, and “how safe” IVF is . It is true that there are risks to any surgical procedure; but the truth is, that the risks and complications of surgery and anesthesia from a reversal of sterilization are rare. Think about it. Where could you be safer than in a major medical center's out-patient facility with board certified anesthesiologists? Frankly, the two biggest risks are not surgery and anesthesia, but driving from your house to the doctor's office on major highways, and pregnancy itself. Don't kid yourself. Pregnancy doesn't come without potential risks, and as you know, there can be many different complications during pregnancy and at birth. Highway fatalities occur more often than any risks associated with elective surgery in a young healthy woman. Women are willing to take these two risks everyday.

Maybe it is a good thing, because most fertility specialists are not well trained in doing reversals of sterilization. Most current REI (reproductive endocrinology and infertility) fellowships have little or no training in microsurgical reversals of sterilization, and put most, if not all, their emphasis on training them to do IVF. That is not a bad thing, because IVF can be a successful procedure, but a woman needs to know all her options and those options need to be presented to her without bias. Once the pros and cons of each procedure is discussed, including financial costs, success rates and logistics, and done unbiasedly, then the couple can make their choice as to what procedure is best for them. “Quite frankly, IVF is much easier to do than standing for an hour or so in surgery, and a clinic makes more money”.

Besides “scaring” them with the risks of surgery and anesthesia, it is argued that if you do IVF, not only will you not have to undergo major surgery and lose time for recovery, but also you will not have to worry about future birth control and having to deal with a future sterilization for you or your partner. ACFS's answer to that is, “if you are having to worry about birth control in the future, that is a good problem to have”.

From a more practical point of view, a reversal of sterilization costs much less than a single attempt at IVF, and you can continue trying to get pregnant, “at no charge”; whereas, with IVF, a single attempt is more expensive than the reversal and if you are not successful, subsequent attempts at IVF continue to cost more money. The cost of a reversal of sterilization at ACFS is $7680. This includes everything but the initial consultation which can be used as a credit toward the surgery, and current HIV and hepatitis B and C, which can be done by your PCP and covered by insurance. IVF costs around $11,500 for everything and generally takes 1-3 attempts to be successful. It also requires a work-up (costing about $1500) to be sure not to overlook anything that could affect the success of the IVF procedure. With the reversal of sterilization, most couples will waive the work-up, because, if something is “missed”, it can always be tested for and treated later and nothing is lost financially other than a little time.

FIBROIDS AND ENDOMETRIOSIS DO NOT MEAN YOU CANNOT GET PREGNANT AND NEED A HYSTERECTOMY

Endometriosis can be a painful, chronic disease that affects up to 16% of infertile women and occurs when tissue that lines the cavity of the uterus or endometrium is found outside the uterus - most commonly in the abdomen on the ovaries (sometimes forming a cystic cavity full of blood known as an endometrioma), fallopian tubes, uterus, lining of the pelvis, bladder and the bowel. Endometriosis is generally more common in caucasian women in their late 20's and 30's. One of the most common theories, as to the cause of endometriosis, is that during normal menstruation, the “menstrum” or menstrual tissue, not only comes out of the vagina as a menstrual blood but flows backwards through the fallopian tubes and implants on the above mentioned sites. Once “implanted”, these growths or lesions respond each month, hormonally, to the menstrual cycle in the same way that the normal lining of the uterus does. Each month the tissue builds up, breaks down, and sheds. Menstrual blood in the uterus can exit through the vagina but the tissue and blood shed by these “endometrial implants” have no way of leaving the body. This causes internal bleeding and inflammation of the surrounding tissue; resulting in pain, scar tissue and adhesion formation and possible infertility.

Although, the classic signs of endometriosis are painful periods, pain during intercourse and infertility; some of the worst endometriosis can be pain free. Endometriosis is also associated with repeated pregnancy loss, irregular periods and ovulatory dysfunction. On the other hand, the best treatment for endometriosis is pregnancy.

Uterine fibroids, on the other hand, are benign or non-cancerous growths or tumors, in women of childbearing age, arising from the muscle of the uterus or myometrium. They are made up of connective tissue that grows within the muscular walls of the uterus. They can grow as a simple fibroid or in clusters. These benign tumors can be as small as an inch in size or can grow to eight or more inches. No one is sure what causes fibroids to develop or stimulates their growth but fibroids can lay dormant for months, or even years then, all of a sudden, double or triple in size. Current statistics show that they are 3-5 times more common in African-American women; and slightly increased in women that are overweight for their height and decreased in women that have given birth. The biggest stimulus to fibroid growth is pregnancy, and thus, could cause problems with implantation of the embryo, placentation or development of the placenta, first and second trimester loss, prematurity, premature rupture of the membranes (bag of water) and a breech presentation.

Fibroids can grow on the outer wall of the uterus or subserosal; in the muscle of the uterus or intramural; or right under the lining of the cavity or submucosal, or in the cavity of the uterus, known as intracavitary. The second worst place for fibroids to grow is in the muscle of the uterus (intramural) because they can push into the cavity of the uterus and compromise the blood flow to the baby or push outward and make the uterus think it is bigger than it is and result in premature labor. The worst place for fibroids is in the cavity of the uterus (intracavitary) because that is where the baby grows and results in the biggest risks of complications. Fibroids on the outside of the uterus (subserosal) can generally be a little bigger before they cause problems in having the uterus think that it is bigger than it really is and causing premature labor that may or may not be able to be stopped with bed rest, prolonged hospitalization and medications.

Many times, patients are told that their endometriosis or fibroids are not a problem and that they can go on and have a successful pregnancy without complications. Although, that can be true in many cases, in others, the endometriosis and/or fibroids, can and will prevent you from conceiving or increase your risks of a miscarriage. Patients need to know both possibilities, as well as the risks and complications if nothing is done, and all available options. Many couples do not want to take the risks of not getting pregnant or worse, having a premature delivery, where the baby could have a number of complications or life long problems.

If surgery is recommended, it should be done by someone who has extensive experience and expertise. If a woman is in the childbearing years and has no children or still wants or is thinking about having more children, than hysterectomy is never an option. Far too often, this is the option women are given by their doctor. Endometriosis can be surgically removed and if there is already too much resulting scar tissue and adhesions from long standing disease, the latest data in the literature suggests that endometriosis does not affect the outcome of IVF. If there is pain and pregnancy can be postponed, there are very effective medical therapies that will alleviate the pain and “buy time”. If there are multiple and/or large fibroids, they can be removed successfully and with minimum to no resulting scar tissue. Although, there are other options to shrink fibroids, including the use of lupron and/or uterine artery embolization, both will result in the growth of the fibroids as soon as pregnancy occurs and possibly lead to the above mentioned complications.

If your doctor has advised you that surgery is necessary and you are planning to have a baby now or in the future, be sure to ask a lot of questions. If the word “hysterectomy” is discussed or even brought up, get out. This includes asking the way they plan to perform the surgery. How many of these surgeries have they done? What is their complication and success rates? Are they the best qualified to perform this type of surgery? And most importantly, if this particular surgery can affect your future fertility. In my experience, sometimes gynecologic surgeries performed by excellent surgeons can unknowingly result in future difficulties with conception. In many cases, when fertility preservation is important, it may well be worth seeking a second opinion.

Although, there is no way to know if surgery is “needed” or not, a physician's opinion is just that, an opinion. Ultimately, it should be left up to the couple to decide on whether or not they want to take the risks. If the doctor has taken care of patients with fibroids that have had a good outcome, they probably will recommend not removing them. If they have taken care of patients who have had a bad outcome secondary to their fibroids, then they are going to recommend surgery to remove them. The problem is, there is no way of knowing for sure. No-one can say for sure that the fibroids will result in pregnancy complications; but the one thing that you can say for sure, that by not removing them, you statistically will increase your risk of having complications. There are times when surgery is done to remove fibroids, that if not done, would have resulted in a good outcome, but the couple should be given that choice. In ACFS experience, most women do not want to take the chance of having a bad outcome, and if given the choice, elect to do the surgery and have no regrets. When you deliver a healthy baby at term, nobody second guesses whether or not they should have done the surgery.

SOLUTIONS FOR MULTIPLE UNSUCCESSFUL IVF CYCLES

Unfortunately, not all patients are successful even after doing multiple attempts at IVF. This can be due to a number of reasons including maternal age, elevated FSH levels, poor responses to fertility medication, decreased number of eggs aspirated, decreased rates of fertilization, decreased numbers of embryos available for transfer, decreased quality of embryos, unexplained factors, and variation in the experience and expertise of the embryology laboratory. Thus, couples presenting with repeated implantation failure (RIF) represent a significant challenge for the treating clinic.

There are a number of options for multiple unsuccessful cycles of IVF:

1. Make sure that the entire work-up has been done, including testing (things can change) that is more than one year old and “controversial tests” like antisperm antobodies (ASA) and antiphospholipid antibodies (APA). You need to have a hysterosalpingogram to document that your tubes are open. Closed tubes, or hydrosalpinges, can fill with fluid that can backflow into the uterus and be toxic to implantation. Also, a recent sonohysterogram. Water is injected into the uterine cavity which is viewed with transvaginal ultrasound for filling defects. It is needed to rule out any uterine pathology like polyps or fibroids. At ACFS, our policy is to have a SHG within three months of a uterine transfer. We have seen a normal cavity change in as little as 4-5 months. If APA and/or ASA testing is positive, either one can interfere with pregnancy outcome. Positive APA may interfere with the very early blood flow to the uterus and interefere with implantation. A positive ASA may cause antibodies to attack the paternal contribution of the pregnancy and cause a very early miscarriage, before a woman even knows she is pregnant.
   
   
2. Make sure that you are maximally stimulated for your age. All clinics are concerned with overstimulation and the risk of ovarian hyperstimulation syndrome (OHSS). This is a process in which the ovaries can become enlarged and allow large amounts of fluid to pass across them into the abdmonen sometimes resulting in a very sick patient that needs hospitalization. Although OHSS needs to be taken seriously, it has been the experience at ACFS, that not giving enough medication for a woman's age or circumstances; or cutting down on the dosage of medication, may reduce the risk of OHSS, but it may also cut down on the amount of hormones needed to adequately stimulate normal follicular (egg) production resulting in decreased numbers of eggs, decreased quality of eggs and resulting embryos, and decreased pregnancy rates. Giving less fertility medication doesn't necessarily produce less eggs, it may produce the same number of eggs, but with each egg getting less hormonal stimulation to their receptors and resulting in poor egg quality.
   
   
3. Not all clinics are created equally, and more specifically, some embryology laboratories have more experience and expertise than others. This could definitely result in different outcomes in pregnancy rates and ongoing pregnancies. Although looking at a clinic's success rates are important, you are not always comparing “apples to apples” (IVF). Some programs are better than others and consistently get better success rates, even with more difficult patients. The reasons are sometimes difficult to ascertain and explain why. At ACFS, the more things we can do differently than what you have already done, the greater the odds are that we can be successful. If we did things the same way as what you have already experienced in the cycles that were unsuccessful, then we would expect the same result. That does not mean that the clinic you were at did not do things “right”. On the contrary, it just means that there are different philosophies on how to do things based on experience. Sometimes, to be successful, it takes an additional attempt at a clinic that consistently has high success rates. That clinic, however, needs to be forthright, to let you know, after carefully looking at your entire medical history and embryology laboratory work sheets, if they honestly feel that you can be successful at their program.
   
   
4. After all factors have been considered and you have exhausted all the other options with IVF, and you have still have not been successful, then you need to consider doing something else. Although donor eggs is always an option, there is another and possibly very successful option to consider - ZIFT or zygote intra-fallopian tube transfer or GIFT (gamete intrafallopian tube transfer). ZIFT is a procedure where your eggs are recovered and fertilized exactly the same as with IVF, but rather than keeping them in the incubator, they are immediately transferred back into the fallopian tube via laparoscopy within a day or two. GIFT is a procedure where the eggs are recovered by either transvaginal aspiration or laparoscopy, immediately mixed with sperm and placed back into the fallopian tube, all within a matter of minutes. With GIFT, it allows procreation to occur in the body, which for some religious beliefs, is the only “allowable” means of advanced reproductive technology. Although, the Roman Catholic Church is against all advanced reproductive technologies, including GIFT, but especially ZIFT and IVF; the American Catholic Church approves of the GIFT procedure, but not ZIFT and IVF. The reason to consider the option of either GIFT or ZIFT is the thinking that some embryos do better in the “natural environment” of the fallopian tube rather than the “artificial environment” of the incubator. It could also allow further and more advanced development in the natural environment of the fallopian tube before entry into the uterine cavity, greater synchronization with the uterus, the presence of numerous growth factors in the human tubal fluid may contribute to the development of some early embryos and thus enhance implantation, and may do away with a traumatic cervical transfer in some difficult patients. The problem, of course, is how to identify these embryos in advance. It has been demonstrated in numerous scientific articles that pregnancy rates do not significantly change over the first three attempts at IVF, but decrease by 40% or have less than 5% chance of success after four or more prior failed attempts. Said differently, there is a high and similarly equal chance of success on the first three attempts at IVF but if not successful, then a fourth attempt will offer little success unless there has been a major change in protocol, like the possibilities mentioned in paragraphs 1, 2 and 3, or the “environment” that the embryos are placed into is changed. Depending on a number of different studies, success rates with ZIFT, after three or more unsuccessful attempts at IVF approaches 40%, depending on the patient's age and circumstances. ACFS has probably more experience with GIFT and ZIFT than any other clinic in the world and is one of the few clinics in the United States that offers GIFT and ZIFT as an alternative to having to go with donor eggs.
   
   
   GIFT or gamete intra-fallopian tube transfer - where sperm and eggs are mixed immediately after egg recovery and injected directly into the fallopian tube, allowing fertilization to occur in the fallopian tube
   
   
   ZIFT or zygote intra-fallopian tube transfer - a procedure where the eggs are fertilized outside the body and as soon as fertilization is visibly documented the less than 24 hour old embryos are transferred into the fallopian tube
   
   
   
5. A number of different treatment modalities have been recommended and attempted for unsuccessful IVF to better improve implantation in these patients. These treatments include the options of assisted hatching where a microscopic hole is made in the wall of the embryo to help it “hatch out” before implantation, embryo co-culture, PGD pre-implantation genetic diagnosis where a single cell is removed from a day 3 embryo and sent for chromosome analysis (Preimplantation Genetic Diagnosis - PGD ), prophylactic removal of the fallopian tubes in the cases of large hydrosalpinges or dilated water tubes, and even extended culture to day 5 or blastocyst stage (Blastocyst Transfer). Unfortunately, all these factors should have been considered on the first attempt at IVF, not the third.
   
   
6. At ACFS, we have found one additional option that has proven successful in patients with repeated unsuccessful attempts at IVF - that is the addition of human growth hormone or hGH to the treatment protocol . It is a known fact that hGH is a co-gonadotrophin and, like FSH and LH, is absolutely needed for the full and final maturation of an egg. Although, if measured, a patient will have a normal level of hGH in the blood, some patients do not have enough hGH for all the extra eggs that they make. These patients are impossible to identify “up front” but young patients that make a lot of eggs and have poor fertilization rates or do not get pregnant as expected; or women over the age of 38-39, in ACFS experience, and backed up by the scientific literature, seem to have better success rates when adding hGH to their treatment protocol. At ACFS, it is our policy that all women 38 or older are offered the option of using hGH, as part of their starting protocol for IVF.

REPEATED PREGNANCY LOSS (RPL) DOES NOT NEED TO HAPPEN

The older definition of repeated pregnancy loss (RPL), or what some call habitual abortion (HAB), was three or more pregnancy losses in the first trimester. At ACFS, we think that this is absurd, and feel strongly that no woman should have to go through more than two pregnancy losses before having a complete evaluation to determine the cause. Unfortunately, far too often, the best advice for women with repeated pregnancy loss is “to keep trying”. At ACFS, we do not know a single woman who wants this advice. The loss of a baby, no matter how early in the pregnancy, is, on some level, the loss of a child; and thus, has all the emotional and physical feelings associated with it. Repeated pregnancy losses only compounds these feelings and can lead to increasing stress, anger, frustration, a feeling of loneliness and despair, emptiness and a feeling of a lack of self-worth and failure. You can “not count on luck” that the next pregnancy will be okay when there is a sophisticated work-up and successful treatments available.

One in every five pregnancies will result in pregnancy loss. Although, the odds of losing a pregnancy are 20% with each additional attempt, the chances of losing two or more pregnancies in a row drops to 5%; and, that is the group of woman that should be evaluated for repeated pregnancy loss. The evaluation should be complete and involve the following four categories:

1. Chromosomal
2. Alloimmune - the couple against each other
3. Autoimmune - the woman against herself
4. Non-immune - physical reasons for pregnancy loss

Chromosome testing - would include testing both partners to see if they are carriers for the same lethal chromosome abnormality that would result in repeated miscarriages. The chance that both partners are carriers for the same chromosome abnormality is low at 2-6%. Although most clinics will recommend chromosome testing as part of the work-up; since the yield is so low of finding anything and the tests cost about $600-800 for each partner, ACFS recommends that rather than testing the parents, that on the 2nd loss, to test the products of conception by doing a in-office D&C. That has two advantages. It will tell you the chromosome make-up of the pregnancy, letting you know if the chromosomes were normal or not; and if abnormal, whether it was due to a spontaneous chromosome abnormality that was incompatible with life or due to an abnormal carrier state of the parents. This is very important because recommending a work-up for RPL is based on having two or more pregnancy losses that cannot be explained. Since up to 20% of woman can lose a pregnancy, if the 2nd loss is due to a spontaneous chromosome abnormality, then you only have one loss that cannot be explained and generally a work-up and treatment is not recommended. If the 2nd loss showed that the chromosomes were normal, then a complete work-up should be initiated. It is important to know that 60-70% of all pregnancy loss is due to a spontaneous chromosome abnormality, not a carrier state, that is incompatible with life and is a random event that cannot be prevented under normal circumstances. Because of this fact, ACFS does not recommend doing chromosome testing on the first miscarriage unless the couple wants to know the reason why the pregnancy was lost, even though they understand that 60-70% of the time it will be due to a spontaneous chromosome abnormality and not a carrier state of the parents. However, if this is your 2nd loss, then ACFS feels strongly that you should be given the option of doing chromosome testing on the products of conception (POC) because the results can be very helpful in giving the couple an explanation of why they may have lost the pregnancy and whether or not a work-up should be started or should they just try again.

If there are 2 or more miscarriages due to the same or different spontaneous chromosome abnormalities, then the options would include continuing to attempt pregnancy, “hoping” that the next one will be normal, consider the use of donor eggs, or doing IVF with PGD to determine the chromosome make-up of each embryo and only transferring the normal ones.

Alloimmune testing - would do histocompatibility testing to see if the couple's genetic molecular make-up was similar. Normally, when a woman conceives, the pregnancy is recognized as a foreign object in her body and the immune system makes antibodies against the pregnancy to attempt to destroy it. This is very similar to what happens if bacteria or a virus invades the body. This is a needed mechanism to occur to fight off infection but not very practical when trying to get pregnant. However, in the case of a pregnancy, the immune system has the unique ability to make a second set of antibodies, known as blocking antibodies, that “sit” on the pregnancy sites and protect it from the first set of antibodies that would normally attack and destroy the pregnancy. The ability of the immune system to make these blocking antibodies is triggered by the fact that the pregnancy is different “than oneself” because it has different genetic material from the father. On the other hand, if the parents are genetically similar or histocompatible, than the immune system will not recognize the pregnancy as different than oneself and not make the blocking antibodies, thus, allowing the first set of antibodies to attack and destroy the pregnancy.

This was a very common theory in the 1990's and the treatment was to do immune therapy. In this process you would get your partner's white blood cells by drawing his blood and separating out the white blood cells and injecting a large dose of them into the woman. Since the couple were not identical, just histocompatible, the woman's system would recognize the large dose of white cells as different than oneself and trigger the immune system to make the blocking antibodies that would subsequently protect the next pregnancy from miscarrying. In theory, this made a lot of sense and numerous couples with a history of repeated pregnancy loss did immune therapy. However, after about 7-8 years, when the data was looked at, immune therapy was shown not to make a statistical difference in improving pregnancy outcomes for these couples; and hence, the testing and treatment is no longer recommended. Although, there are a few clinics that still advocate this treatment, it is no longer the standard of care for repeated pregnancy loss, and ACFS does not recommend it. Similar data showed that intravenous gammaglobulin (IVIG) showed no statistical improvement in preventing pregnancy loss and is also not recommended by ACFS.

Autoimmune testing - is evaluating the woman to see if she is making microclots, by a number of different mechanisms, that can interfere with the blood flow to the early pregnancy and subsequently cause a miscarriage. Once all the other causes of pregnancy loss have been ruled out, this is the most common thinking for the etiology of repeated pregnancy loss. Testing would include anything that could trigger the women's own system to increase micro-damage and microclotting. The most common mechanism is that antibodies are made against the blood vessel walls and damage the walls. Once a blood vessel wall is damaged, platelets that are floating around in the blood stream, come out of solution and because of their inherent stickiness, stick to the area of damage and begin the healing process. Once platelets are out of solution, they trigger the clotting factors to come out of solution, thus forming a clot that attaches to the injured blood vessel wall and continues the healing process. These micro-injuries and micro-clots to the blood vessel walls are of no consequence to the major blood vessels of the body; but, in the smaller tiny blood vessels of an early developing pregnancy, they can block off blood flow to the early pregnancy and cause a woman to lose the pregnancy between ovulation and her period; or between 6-8 weeks, when there is an increased demand for blood flow to carry nutrients to the baby.

Testing would include antiphospholipid antibodies which are antibodies against the fatty portion of the blood vessel wall that can attack the wall and trigger the micro-damage and micro-clotting as part of the healing process; fasting homocysteine levels, an amino acid found in the blood, that if elevated, can also increase the risk of micro-clotting (and is treated with high doses of folic acid); prothrombin and Protein S and C deficiency that can also increase micro-clotting, normally these proteins are natural inhibitors of clotting but with a deficiency can increase the clotting cascade leading to a increase in the formation of micro-clots; and Factor V Leiden mutation, causing activated protein C (APC) which prevents clots from growing too large, to be unable to inactivate one of the important clotting factors, factor V, normally, resulting in increase risks of micro-clots.

Treatment of this category is aimed at prevention of the micro-damage and micro-clotting. This includes the use of low dose prednisone to decrease the antibody response against the blood vessel wall and to decrease or avoid damage to the wall, baby aspirin to decrease the stickiness of the platelets and low dose heparin to stop the clotting mechanism from making a micro-clot. All of these medications must be started before the woman conceives. Therefore, ACFS recommends that a couple use some means of birth control until the entire work-up is completed and treatment is started. Starting treatment after the fact, when a woman learns she is pregnant, is of little to no value. By the time most woman find out they are pregnant, they are already 3-4 weeks along and the micro-damage and micro-clotting has already occurred.

Non-immune testing - this would include everything that is not related to the above three categories and consists of the following tests: sonohysterogram to rule out any uterine pathology, like polyps or fibroids which can increase the risk of pregnancy loss; prolactin and thyroid levels, that if elevated, are associated with pregnancy loss, endometrial biopsy to make sure that the lining of the uterus is prepared properly for implantation and is supportive of an ongoing pregnancy; semen analysis to rule out white cells or bacteria in the semen that have also been associated with increase pregnancy loss; general cervical cultures; mycoplasma culture, a less commonly recognized bacteria that can bind with the embryo causing a mycoplasma-embryo complex that white blood cells attack leading to an increase chance of miscarriage; and antisperm antibodies, where antibodies against the paternal contribution to the embryo attack the early pregnancy and lead to an increase risk of pregnancy loss.

As you can see, there is a sophisticated work-up for pregnancy loss, that in the majority of the cases, will identify the cause(s) of why a woman is continuing to lose her pregnancies. Treatment is also very sophisticated and is aimed at correcting any of the non-immune problems; and if they are all normal, then treating the autoimmune problems with low dose prednisone, low dose heparin and baby aspirin. Complications from low dose prednisone are rare and the dose of heparin is so low that it will not change normal bleeding times. These are carefully monitored throughout the treatment regimen with bleeding times which are kept in the normal range; and, if you were to cut yourself, you would clot and stop bleeding in the normal fashion. The low dose heparin, injected right under our skin, only interferes with clotting at a microscopic level. All medications are started prior to attempting pregnancy and continued until the end of the 12th week of pregnancy when the pregnancy blood vessels are large enough and are not affected by the micro-clotting. At that point, heparin is discontinued, you taper off prednisone over the next three weeks and baby aspirin is continued until 34 weeks of pregnancy. None of these medications have any adverse risks to the pregnancy or the baby.

Also, at ACFS, we have found additional benefits to reducing the risks of pregnancy loss by adding 200 mg of natural progesterone, in the form of sub-lingual lozenges twice a day; and, the use of low dose injectable fertility medication, mainly human menopausal gonadotrophin (HMG). It has been our continued experience that HMG may “make better eggs”, a “better hormonal environment for pregnancy to occur in” or “treat something that we do not know how to test for in 2009”; and, therefore, always include them as part of our protocol for repeated pregnancy loss; along with the prednisone, heparin and baby aspirin. What ACFS calls its 5-arm treatment protocol for repeated pregnancy loss. Clomid, on the other hand, is never used and may even be detrimental and increase the risk of pregnancy loss by interfering with the lining of the uterus. Even if the entire work-up is normal and nothing can be identified as to the cause of pregnancy loss, the couple is still given the option to do the complete treatment protocol of baby aspirin, prednisone, heparin, progesterone and HMG. ACFS believes that the autoimmune tests may come “in” and “out” of the normal range and thus random testing may overlook an abnormal value. By being proactive rather than reactive and doing the full treatment protocol, it will statistically improve your outcome. The statistics at ACFS show a significant improvement in pregnancy loss when the above protocol is implemented prior to conceiving and followed through the 12th week of pregnancy. It is our strong recommendation, that if a couple has lost 2 or more pregnancies in the first trimester, that they use some means of birth control until the complete work-up is finished and treatment is started. By not doing this, one cannot expect the outcome to be different.

As a last option, donor eggs or a gestational carrier can be considered. Interestingly, the more genetically different the embryo is to the uterus the greater the chances that you will not miscarry. Just the opposite of what you would think. These are viable choices that have to be considered when everything else has been unsuccessful including continued loss in the face of correcting anything that is found to be wrong and use of the 5-arm treatment protocol.

BEFORE PROCEEDING WITH TREATMENT YOU SHOULD KNOW ALL YOUR OPTIONS

This is at the very heart of ACFS philosophy for the evaluation and treatment of infertility. Make sure that you are given the option to do the entire work-up, even controversial testing . Up to 35% of couples have more than one reason for why they are not conceiving. One of the biggest mistakes that is made, is once a problem is identified, the rest of the work-up is not completed, many times overlooking a less likely but equally important problem; and thus, preventing treatment of the initial problem to be successful. As an example, many clinics do not test for antiphospholipid antibodies unless you have a history of repeated pregnancy loss, in which case, you may test positive for these antibodies. The argument is that fertile women can also test positive for APA and yet have no problems with conception or carrying a pregnancy to term. This is true, although, almost all programs will not do the test until after you have 2 or more pregnancy losses. Why wait until you have 2 documented pregnancy losses before doing the test? ACFS believes it is better to be proactive than reactive; not to mention the emotional and physical trauma of losing 2 or more pregnancies that possibly could have been prevented. The other mistake that is made way too often is, just because a woman is young, she is not taken as seriously, and a complete work-up is not done and only conservative, not aggressive treatments are discussed, let alone offered. ACFS believes that a complete work-up should be discussed with every patient, regardless of their age or circumstances, and that they should be given the option of whether or not they want to do the entire work-up or only parts of it. It should always be the couple's choice; and by not choosing to do the complete work-up, they are aware of the possible risks of overlooking something that may interfere with their treatment being successful.

Once the work-up is completed, make sure that the clinic gives you all your treatment options, from conservative to aggressive and it is done unbiasedly. You should be told the pros and cons, logistics, finances and success rates of all available choices and it should be done unbiasedly. Once you are clear on the pros and cons of each one of your choices then you should choose the option that is best for you, not the clinic. Even if you are young, it is your choice to be conservative or aggressive. You need to feel that you are being taken seriously, no matter what your age is. A woman in her 20's has the same feelings and desires as a woman in her 40's, the only difference is that the woman in her 20's has a bit more time. With a woman in her late 30's to early 40's, although conservative treatment could work, it should be her choice as to whether or not she wants to be aggressive. ACFS feels strongly that a woman's choice should be listened to and honored.

THE DOWN SIDE OF GETTING FERTILITY MEDICATION ONLINE

Arizona Center for Fertility Studies fully supports a patient's right to choose where their fertility drug prescriptions are filled. We do not, however, support the purchasing of medication without a prescription from a licensed physician and from a certified licensed pharmacy. ACFS also does not support any treatment that is undertaken without a physician's evaluation and supervision. Fertility medications are extremely safe and very effective when used in a controlled environment. On the other hand, these drugs can be very dangerous and potentially life threatening when they are not administered and carefully monitored by an experienced fertility health care professional, trained in reproductive medicine. Remember MJ!

ACFS does not condone or support purchasing fertility medication, oral or injectable, over the Internet. Although completely sympathetic to the reasons why someone would purchase these medications “from an online stranger”, the potential risks would include:

1. Potential for contamination of the drugs (remember the Tylenol incident)
2. Dangers and risks associated with self-treatment
3. It is illegal to sell or distribute medications without a license
4. Potential for fraudulent activity by charging more than the seller paid for the medication.
5. Unknown whether the drugs have expired and replaced with current packaging.

If you are unwilling to give your name, phone number or credit card information over the Internet, why would you purchase medications that you will be injecting into your body from a total stranger?

The real problem is not the Internet, it is the insurance companies. If there were appropriate coverage for fertility medications and treatments, some couples would not have to look for potentially unsafe ways to reduce their costs. Although this is not the forum to discuss insurance companies and infertility benefits, patients and physicians need to join forces to mandate legislation for all insurance companies to provide benefits. The medical circumstances causing a woman to have difficulty conceiving is as much of a medical problem as breaking a hip, pneumonia or heart disease. Numerous states have already mandated such coverage.

There are safe alternatives to the potential risks of purchasing fertility medication over the Internet from a stranger. Shop around at different pharmacies because prices can significantly vary. ACFS works with The Compounding Pharmacy, and as far as we can tell, they have the “best” prices in the Valley.

CLINICS SHOULD BE GENDER FRIENDLY AND NON JUDGEMENTAL

Since its inception in 1982, ACFS had embraced all patients, regardless of age, marital status or gender preference. ACFS strongly believes that a full service, state of the art, infertility program does not have the right to be judgemental and refuse treatment to any woman, single or married, gay or straight, normal weight or overweight, young or old, unless there as a documented medical indication for not treating that person. Personal feelings and belief systems should have no place in deciding whether or not to help a woman pursue her most precious dreams. Clinics and physicians should not allow their personal opinions and beliefs to interfere with who they will care for and the advice that they give to their patients. The decisions that they make should never compromise their integrity or be dishonest, but should also not reflect their personal viewpoint, only their best unbiased medical judgement. An example of this would be in discussing selective reduction or having to terminate one or more babies in a multiple pregnancy. First of all, the program should do everything they can to avoid a multiple pregnancy and know up front if the couple is opposed to having any more than one child. However, even when following the American Society of Reproductive Medicine guidelines, multiples can occur, either from all the embryos “taking” and/or one or more of those embryos “splitting” into identical twins or triplets, rare as it may be. The couple needs to be made aware of the option of selective reduction and it needs to be done unbiasedly and without prejudice. Even though the clinican may be religious and not believe in termination, he or she should not have that influence the medical conversation and the options presented to the couple. It is the couple's right to choose the option that is best for them, unfettered by the clinican's personal belief system, bias or possible suggestion of guilt. The decision is hard enough as it is and will take an incredible amount of soul searching and conversation on the couple's part to arrive at a decision that is comfortable for the both of them. ACFS believes a clinic's role is to support their patient's decision, whether or not they agree with it. Only if a patient asks, should a personal opinion be given. When asked at ACFS, “what would you do if you were me”, the answer is, “it does not matter what I would do, what would you do”?

With 5-10% of the population being comprised of same sex relationships, clinics are bound to have a similar percentage of same sex couples inquiring about treatment options. ACFS makes no distinction between heterosexual and homosexual couples and strongly feels that both should be treated equally and non-judgementally, and without bias or prejudice. These couples are just as deserving and motivated as any other couple, and in ACFS experience, make equally good parents. As a side point, ACFS does not necessariy have an opinion on whether or not there should be a constitutional amendment recognizing gay marriages but feels strongly that same sex relationships should have the right to a civil marriage and all the legal rights associated with that marriage, ie. eligibility to receive their partner's health benefits, the right to adopt their partner's child, and shared custody of that child if they became separated. Currently, there are very few states in the country that allow for these benefits, and Arizona is definitely not one of them.

Weight and age should also not be a factor in deciding whether or not to treat a patient. Some clinics will not provide treatment for woman over a certain BMI or body weight; and refuse treatment for woman over 41-42 if they want to attempt pregnancy using their own eggs and are not open to using donor eggs. ACFS feels strongly that any woman should be given the chance to conceive regardless of age and body weight. That does not, however, release them from the medical responsibilities of discussing the risks and complications of being overweight in pregnancy and resulting potential dangers to their unborn baby; or the decreased chance of success if she is older and the increase risks of miscarriage and chromosome abnormalities in her age group.

Before proceeding with a patient who is 25-30% over her ideal body weight, she will have to have a consultation with a perinatologist and subsequently present with medical clearance before ACFS will proceed. Many times, as long as the woman understands her risks and potential complications and is advised of things that she can do to avoid or reduce them, she will get medical clearance and can proceed with and have a successful pregnancy outcome.

ACFS believes, that there should be no “magic” cut off age where a woman must use donor eggs. Obviously, within reason, there is no way of knowing if an older woman is “reproductively young” or if a younger woman is “reproductively old”. Without attempting pregnancy, there is no way to find out. ACFS has many examples of older women getting pregnant and going on to have a healthy normal baby. There is always time in the future to consider the option of donor eggs, if using their own eggs has not been successful. Many women just want the chance to attempt pregnancy before having to make the difficult descision on whether or not they want to proceed using donor eggs, adopt or stop treatment; and at ACFS, they will have that chance, as well as, the possibility of being successful.

MULTIPLES - WHY THE FEAR?

by Dr. Jay S. Nemiro

“The recent birth of octuplets in Los Angeles has generated a media frenzy in the United States and around the world. Although we marvel at the live birth of eight babies, and give recognition to medical science and our colleagues who ensured their healthy delivery, this event has created a firestorm of controversy: How did this happen, especially with in vitro fertilization, when the number of embryos transferred is controllable? How did a woman who already has six children, is single, is a student living with her parents, and who receives state disability payments undergo IVF? How did the physician who provided care make his decisions? What is the standard of care? Who is going to pay for this? How can this be avoided in the future? Fertility physicians everywhere share all these concerns and are asking for action”.

OctoMom and the birth of her octuplets was a disaster, a real failure of IVF technology. It should have never happened. But the “story” started almost 30 years ago with the birth of the first IVF baby in England in 1978. Although, many marvelled at the new and amazing technology, early success rates with IVF were poor at around 5+%, on a good day. Over the next two decades or so, the field witnessed, not only a prolific growth in the number of IVF clinics around the country, but the obvious and ever present media attention to the growing number of multiples and, particularily, high order multiples of 4, 5, and 6+. Actually, our society got so desensitized to hearing about another set of high order multiples that were born, that we created a reality show and watched it religiously. “Jon and Kate plus 8” should have never happened and it was a growing sign of our society's complacency and ignorance of multiple births. Yearly statistics started showing a significant statistical increase in the number of twins, triplets, quadruplets, and higher order multiples being born at an alarming rate.

This happened for two reasons. First, there were 380 clinics in the United States by the end of 2000. Second, although IVF success rates were improving from those early years, clinics had gotten used to putting back a lot of embryos, not necessarily to have better statistics than their neighboring clinics, as many outsiders accused us of, but in an attempt to make sure that the couple was successful and, in many cases, to honor their wishes of putting more back, again, in the hope that they would be successful and not have to do this “god awful procedure' again. For the most part, when a couple was successful, they only had one or two babies at the most, but occasionally that would backfire and the couple ended up with high-order multiples.

With a woman having trouble getting pregnant, known as “infertility", or when multiple women can not get pregnant over multiple cycles, which is due to some environmental issue like blocked tubes or a low sperm count ; on the other hand, the new word is “fecundity”. This is the ability of a single woman to get pregnant on a single cycle, and is related to her reproductive genetics. Is she “reproductively young or reproductively old”? Without knowing this, there would be no way to know if a woman that you transferred 4 embryos would have one baby, 4 babies or no babies. With almost 400 clinics thinking the same way, not only did the incidence of multiples increase significantly, because any given woman's fecundity was unknown, but it was causing more and more public awareness and concern, raising health costs, more premature births and the many associated problems and complications with prematurity.

Finally, the government got involved and told our Society, “either you solve this problem or we will”. Having the government involved in any health care, let alone threatening to regulate our industry, would be a disaster and a grave disservice to our patients and would set IVF technology back twenty years. As a result, our Society, after carefully evaluating the success and statistics of IVF over the previous 20+ years, came up with guidelines based on sound scientific and clinical evidence regarding the number of embryos to transfer and were first published in 1998 and revised downward in 1999, 2004, 2006, 2008 and more recently in 2009 as the efficacy of IVF improved. By the beginning of 2006, almost all clinics in the country were following these guidelines and over the next 2-3 years the incidence of multiple births dropped significantly. If you think about it, other than the birth of the octuplets, you have not heard much in the news about multiple births.

Although, ACFS has had its fair share of multiples in the past, since following the guidelines, our incidence of multiples has significantly dropped and no one over the age of 35 has gotten fraternal triplets. Also, pregnancy rates have continued to improve as well, an initial concern that ACFS had if fewer embryos were transferred. Identical twining occurs in 1 out of 250 pregnancies and cannot be controlled. However, many women, even older women who are not really at much risk, still talk about their fear of having multiples. ACFS thinks this is due to just not understanding the reasons multiples occurred in the first place and the lingering conditioning from the media. The truth is, with the current practices, the risk of having high order multiples is extremely unlikely and women can be reassured that they will only have one or occasionally two babies, depending on their age. With our success rates being so good, ACFS will not be talked into going outside the guidelines unless there is a legitimate and medical reason to do so; and even then we will only put one more embryo back.

“Our Society and their members long have been concerned about problems created by multiple births, including the best interests of the children born. The guidelines published in 1998 and afterwards clearly show the success of professional self-regulation. National data on in-vitro fertilization using fresh non-donor egg cycles show (1) the percentage of deliveries with triplets or higher has been reduced from 6.9% in 1996 to 1.7% in 2007, (2) the percentage of egg retrievals in 2007 that resulted in the delivery of triplets was only 0.6%, and (3) the percentage of embryo transfers that resulted in at least one live birth increased from 28% in 1996 to 34.3% in 2005. The recommended number of fresh embryos to transfer in a patient younger than 35 years old with a good prognosis (i.e. good embryo quality and no history of repeated prior failures of IVF treatment, or chromosomal rearrangement) is one or at the most two. Owing to the lower chances of frozen embryos implanting, an additional embryo often is added in frozen embryo transfer cycles. Guidelines allow flexibility among IVF clinics and patients depending on other prognostic factors to allow for individualized patient care.

Some have called for more regulation of IVF. Yet IVF is already one of the most carefully regulated, accredited, and audited areas of medicine. Regulation, like in England, where only one embryo can be transferred, would be a disaster and a grave disservice to our patients and would set IVF in the US back twenty years.

SART sets rigorous personnel and procedural standards. The Fertility Clinic Success Rate and Certification Act of 1992 requires annual reporting of pregnancy and live birth rates to the Centers for Disease Control and Prevention (CDC), the College of American Pathologists and ASRM, as well as to The Joint Commission accredit embryology laboratories which requires on-site inspections every 2 years, and to the Food and Drug Administration which regulates many aspects of gamete and embryo donation. These guidelines, standards, licenses, and regulations have been successful in improving the success, health, and safety of women undergoing IVF treatments and their resultant newborns. It should be noted that strict reproductive technology regulations in other countries have not been a panacea and are almost always associated with state coverage of the cost of assisted reproductive technology treatment. Those regulations sometimes have resulted in reduced pregnancy rates and denial of treatment to many women based on demographic factors and have promoted cross-border reproductive care. A recent news story in the BBC (England) stated, that less than 20% of women get to do IVF three times. This is significant, because even though the government pays for IVF, the law states that only one embryo can be transferred, thus resulting in much lower pregnancy rates per transfer. However, in the United States, private reproductive and parenting decisions never have been regulated, and this includes the decision parents and their physicians make regarding the number of embryos to transfer in IVF. Although some have suggested regulation in response to this extremely rare birth of octuplets, such action would ignore the success of professional standards and self-regulation, not only in this area of medicine but also in many others. Such action would be particularly troubling in reproductive medicine, where issues of personal choice and reproductive rights should be protected for everyone, and not just for infertility patients. Furthermore, no regulation will completely prevent substandard, immoral, illegal, or unethical behavior on the part of physicians or patients. Social justice requires a response to this event. ASRM and SART have called for a comprehensive evaluation of the medical practice in question and the physician and clinic involved was expelled from our Society.

The Society for Assisted Reproductive Technology also is reevaluating its guidelines regarding the number of embryos to transfer based on the most recent clinical data submitted by SART programs and is making its internal quality assurance and validation policies and procedures more stringent. We also call for more support for research in IVF and for better insurance coverage for infertility care to help reduce patient motivation to transfer too many embryos. Physicians' compliance with practice standards could be helped by legal protection from unreasonable patient requests. The Medical Board of California, as well as those of other states, has the right to levy sanctions, including loss of medical licensure, for care that does not follow national standards.

In summary, this tragic situation has focused our attention on the problem of multiple births from IVF. ASRM, SART, and their members have made much progress with this issue. Application of currently available regulations, guidelines, and professional organization procedures will protect the health, safety, and rights of women, children, and our society. The Society for Assisted Reproductive Technology and ASRM, as well as other stakeholders in reproductive medicine, are actively evaluating changes in the current system that can be made to reduce the risk further and hopefully to prevent another tragedy in the future”.

Parts of this section were reprinted from an editorial by David Adamson, M.D. and Elizabeth Ginsburg, M.D. from ACOG, volume 113, No. 5, May 2009, pages 970-971.

REVERSAL OF VASECTOMY VS. IVF?

In the case of a vasectomy, where the tube or vas deferens, leading from the epididymis to the penis has been surgically cut, sperm cannot get out. On ejaculation there is no sperm in the semen. Semen comes from the prostate gland and the seminal vesicles and is not effected by the vasectomy. In cases where a man wants to have future child bearing potential, he has two choices. One is to do a reversal of his vasectomy, the other is to do IVF and recover sperm from the epididymis (MESA/TESA). The advantages of doing a reversal of the vasectomy, known as a vasovasotomy, is that the couple can attempt pregnacy by having intercouse.

The disadvantages of a vasectomy reversal are as follows:

1. It is expensive and generally costs around $7,000-$10,000; similar to the cost of a cycle of IVF-ICSI.
   
   
2. Not all urologists have the same experience and expertise and thus get different results.
   
   
3. There may not be enough of the vas deferens to put back together because too much was removed at the initial vasectomy.
   
   
4. Even if the vasectomy reversal is successful and the two ends can be put back together, it can close down or become blocked within 1-2 months after the procedure.
   
   
5. Even though the surgery is successful and there are sperm in the ejaculate, the quality of those sperm parameters (numbers, motility and morphology) may be so low that neither intercourse or SO-IUI will be successful and the couple will have to do IVF-ICSI to achieve pregnancy. The poor sperm parameters are generally due to the consequences of a long standing vasectomy. Generally, when the vasectomy was done longer than 9 years ago, although you can get sperm in the ejaculate, overall pregnancy raes are low. Even when the vasectomy was done 2 years ago, the sperm parameters can be extremely low and IVF-ICSI has to be done to achieve pregnancy. These poor sperm parameters are due to back pressure that develops in the testicle from preventing the sperm from getting out with ejaculation. Even with a vasectomy, the testicles still produces sperm. With no way to get out, pressure builds up in the testicle, damaging the “factories” or semeniferous tubules or cells that produce sperm. In these cases of poor sperm parameters after a vasectomy reversal, ACFS has found that fertility medications (Clomid), sometimes used to improve spermatogenesis in men with low sperm counts, are generally ineffective and do not improve the sperm parameters. This is because the “factories” that are producing the sperm are damaged and can no longer function properly to produce sperm. However, even though the sperm parameters are poor, the sperm that is available can be very successful in fertilizing an egg when IVF-ICSI is done, with good pregnancy outcomes.
   
   
6. As a result of the vasectomy there is a break in the blood-testes barrier and sperm or sperm components can get into the blood stream. Since the immune system has never seen sperm or sperm parts before in the blood, it makes antibodies against these sperm, known as antisperm antibodies, which attach to the sperm. This is generally of no consequence until the man wants future childbearing ability and decides to reverse his vasectomy. Since the ASA are so small they can pass into all parts of the body including the testicules, epididymis and vas deferens. As a result, after a successful vasectomy reversal, and there are sperm in the ejaculate, the ASA can attach and bind to these sperm and immobilize them, so they have no motility and thus cannot fertilize or produce a pregnancy. ACFS strongly recommends, that before any man has a reversal of his vasectomy, he has his blood drawn to evaluate for ASA. An ASA showing less than 40% of the sperm bound by antibodies is normal and if the man wants to proceed with the reversal instead of IVF, then it is okay. If the ASA shows greater than 40% of the sperm bound by antibodies, and it is not atypical to see 80-90+% bound, then reversing the vasectomy may be successful in regard to sperm production, but most, if not all of the sperm may be non-motile and will be achieve a pregnancy.
   
   
7. It requires surgery with anesthesia and there can be complications, although they are uncommon.
   
   

ACFS strongly recommends that before a man decides to have a reversal of his vasectomy that he is given the pros and cons, as well as the risks and complications, finances of the reversal vs. IVF-ICSI and the success rates of each, before the couple makes their decision. Once the couple is aware of the pros and cons of each decision, then they can make the choice that is best for them. Although, vasectomy reversals can be successful in the hands of an experienced urologist; far too often, when it is unsuccessful or the sperm parameters are poor, the coupe has to be looking at doing IVF-ICSI to achieve a pregnancy, they state, “they were never told of any other options”.

SHOULD I DO AN AMNIOCENTESIS?

Amniocentesis is a procedure in which amniotic fluid is removed from the uterus for testing or treatment. Amniotic fluid is the fluid that surrounds and protects a baby during pregnancy. This fluid contains fetal cells and various chemicals produced by the baby. With genetic amniocentesis, a sample of amniotic fluid is tested for certain chromosome/genetic abnormalities — such as Down syndrome and spina bifida (or the open spinal cord in the baby). With maturity amniocentesis, a sample of amniotic fluid is tested to determine whether the baby's lungs are mature enough for birth. ACFS believes that chromosome/ genetic amniocentesis should be offered when the test results may have a significant impact on the management of the pregnancy, or the woman's desire to continue the pregnancy.

Amniocentesis is usually done after the 13-15th week of pregnancy, when the two layers of the fetal membranes, the chorion and amnion, have fused enough to safely withdraw a sample of amniotic fluid. It is rarely done before that because of safety concerns. Under ultrasound guidance, a sterile needle is passed through the abdominal wall and into the amniotic sac. A small amount of fluid, containing the baby's cells, are removed and sent for genetic/chromosome analysis. The results take about 3+ weeks. This makes the decision to terminate the pregnancy even more difficult, since the woman is well into the 2nd trimester, and probably, because she had done a reproductive procedure like IUI or IVF, she has had considerable pregnancy symptoms and probably has watched the baby grow on ultrasound

The following are the most common indications for a woman to consider doing an amniocentesis:

• You had abnormal results from prenatal screening test - AFP (alpha fetal protein) and/or TNL (transnuchal lucency - measurement of the amount of fluid behind the baby's neck).
• You had a chromosomal abnormality (Preimplantation Genetic Diagnosis - PGD) or neural tube defect in a previous pregnancy.
• You're age 35 or older.
• You have a family history of a specific genetic disorder, or you or your partner is a known carrier of a genetic disorder (Preimplantation Genetic Diagnosis - PGD).
• You have a suspected uterine infection or Rh incompatibility (where your blood is negative and the baby's and father's blood is positive).
• You are just worried about a chromosome abnormality (Preimplantation Genetic Diagnosis - PGD) and/or the results may have a significant impact on the management of the pregnancy - or the desire to continue the pregnancy.

Risks associated with amniocentesis are as follows:

1. Miscarriage. Early amniocentesis carries a slight risk of miscarriage, often due to rupture of the amniotic sac. The risk of miscarriage is highest when the procedure is done early in pregnancy, before the two layers of fetal membranes have sealed. By the second trimester, however, the risk of miscarriage drops. For years, the risk of miscarriage was generally considered to be 1 in 200. Today, in many centers, the risk is between 1 in 300 and 1 in 500, but only if done by someone with considerable experience and expertise.
2. Cramping and vaginal bleeding. Cramping is possible after amniocentesis. Some women experience a small amount of vaginal bleeding, but neither results in pregnancy loss.
3. Needle injury. During amniocentesis, the baby may move an arm or leg into the path of the needle. Serious needle injuries are rare.
4. Leaking amniotic fluid. Rarely, amniotic fluid leaks through the vagina after amniocentesis. If the leak seals, the pregnancy may proceed normally. Sometimes the leakage can lead to a decrease in the amount of amniotic fluid, that serves as a cushion for the developing fetus. If the leak is severe enough, it can cause skeletal deformities secondary to compression of the baby within the uterus.
5. Rh sensitization. Rarely, amniocentesis may cause the baby's blood cells to enter the mother's bloodstream. If the mother is Rh negative but the baby's red blood cells are Rh positive and pass into the maternal blood stream; it makes antibodies against them. This is because the woman's immune system has never seen Rh positive blood cells. The antibodies are small enough to pass across the placenta and attack the baby's Rh positive red blood cells and destroy them. If a woman is Rh negative, she should be given RH immunoglobulin (gammaglobulin) after the amniocentesis, so if there is any blood to blood transfusion between the mother and the fetus, the gammaglobulin attaches to the baby's Rh positive red blood cells and prevents the mother's immune system from recognizing and attacking them.
6. Infection. Although uncommon, amniocentesis may trigger a uterine infection. The resulting infection may trigger premature labor that cannot be stopped or effectively treated with antibiotics.

ACFS recommends that chromosome/genetic amniocentesis should only be offered when the test results may have a significant impact on the management of the pregnancy or the desire to continue the pregnancy. The decision to do an amniocentesis is an extremely important one, especially in reproductive medicine. Because the potential complications of amniocentesis can result in losing a normal pregnancy, and everything that the woman went through to achieve that pregnancy, the risks versus the benefits, needs to be carefully weighed. ACFS believes, that the decision to terminate a pregnancy secondary to a chromosome abnormality like Downs Syndrome, is an extremely difficult and sometimes emotionally painful one, involving so many emotional, religious, spiritual, psychological and ethnic aspects. It is a decision that the couple needs to make alone or with family, and the clinic needs to be non-judgemental and support whatever decision they make.

If the AFP and TNL are both normal, there is an 85% chance that the baby is normal and does not have Downs Syndrome. The couple needs to weigh those odds against their risk of having a Downs Syndrome baby and the risk of complications from having the procedure before making their decision.

An alternative to amniocentesis is CVS or chorionic villus sampling. The chorionic villi are tiny finger-shaped growths found in the placenta. The genetic material in chorionic villus cells is the same as that in the baby's cells. During CVS, a sample of the chorionic villus cells is taken for chromosome/genetic evaluation, similar to what is done with the amniotic fluid sample. The main difference between CVS and amniocentesis is that the procedure is generally done late in the first trimester between the 10th to 12th week, and the results are available in 7+ days. This allows the couple to know the health of the baby much sooner and make a decision earlier whether to continue or end the pregnancy.

The indications and risks of complications are similar to those of amniocentesis and, if the woman decides to have a CVS instead of an amnio, it also has to been done by someone with considerable experience and expertise.

VARICOCELE SURGERY - DO I NEED IT?

Approximately 40-50% of the time the difficulty with conceiving is due to a male factor and a varicocele has been implicated as one of those causes. A varicocele is an abnormal tortuosity and dilation of veins of the pampiniform plexus of the spermatic cord in the scrotum, and is commonly called “varicose veins of the testicle”. The most common theory of how a varicocele can affect sperm quality is by raising the temperature in the testicle from the increased blood flow. Normally, temperature in the scrotum is 2 degrees centigrade (celsius) less than the rest of the body. Increased temperature in the scrotum is the most popular theory as to the cause of decreased sperm parameters, although, there are others. Sperm motility and sperm numbers are commonly affected, and less so, morphology.

Varicoceles are common and are found in 10% of normal men. They are more common in the left testicle but can involve both sides. With one out of every six couples having difficulty with conceiving and 50% of those due to the male, it is sometimes difficult to decide, especially if the male has a varicocele, is it the cause of the male infertility or just coincidence?

The diagnosis is often made by a urology specialist on a routine examination or if the male has decreased sperm parameters and is sent to the urologist for evaluation. Urologists often diagnose and commonly recommend surgical repair of the varicocele in men with abnormal SA. The problem is, surgically correcting a varicocele, known as a varicocelectomy, often does not improve the semen quality enough to change the therapy that will be required to result in pregnancy for the couple. A number of scientific studies have shown that varicocele surgery may improve sperm parameters (counts or motility), but randomized and controlled trials do not consistently show improved pregnancy rates. Therefore, because of these studies and ACFS experience in tracking pregnancy rates in infertile males who have had varicocele surgery, and have seen no statistical improvement in pregnancy rates, has not recommended varicocele surgery for the past 15+ years.

Statistically, in these couples, where there is a male factor as the cause of the infertility, the couple will need IUI or IVF anyway, so ACFS asks, “why waste time and money on surgery for a varicocele”? To be fair, there is no way of knowing if the surgery “could” improve the sperm parameters enough to result in a pregnancy. ACFS believes that the couple needs to be given the pros and cons, as well as the unbiased results in the literature of varicocele surgery vs. no varicocele surgery, before they make their decision.

For couples that cannot or do not want to do infertility treatments when a male factor is found to be the reason for their difficulty with conception, there are some criteria to consider before making the decision to have varicocele surgery. If the count is under about 5 -10 million per cc, or the sperm motility is 30% or less, it is unlikely that the semen quality will improve enough after a varicocele repair to result in pregnancy without IUI or IVF. Men with sperm parameters that are just slightly low (15-20 million and motility at 50%) and the female work-up is normal, may be more reasonable candidates for varicocele surgery. However, most couples with sperm parameters in this range will probably conceive on their own without surgery. There are as many studies in the literature showing varicocele surgery makes no difference in pregnancy outcome as there are that shows it does. In younger couples, or where the surgery may be covered by insurance and the infertility treatments are not, the male may decide to have the surgery and “see what happens”. Generally done under general anesthesia, the procedure is relatively easy, quick and associated with few complications. If the couple is not successful in 6-9 months then either IUI or IVF can be discussed.

THE ART OF SURGERY

By Gina Caiazza RN,CNOR,RNFA
ACFS Program Coordinator

Having been a long-standing member of the Association of Operating Room Nurses (ARON), an OR nurse since 1983 and an RNFA (RN First Assistant) since 1987, I have had the privilege of working with numerous surgeons over the past 26 years. I feel it is a fair assessment to say that not all surgeons are equal in skills and ability. There are major differences in technique, experience and the objective of the surgeon performing a surgical procedure. Sure, all physicians go through the mandatory surgical training during their residencies and/or fellowships, but not everyone excels at the given task at hand or gets the same surgical experience. The primary goal of surgery should be to remove the diseased tissue or pathology and avoid the potential long-term side affects such as scar tissue and loss of normal anatomy. In reproductive surgery, I believe that the primary goal should be to preserve future child bearing potential; and secondarily, to remove the pathology.

In the field of reproductive medicine, the consequences of surgery can be monumental and although it may correct the underlying pathology, it could result in subsequent damage to surrounding tissue or even impair a woman's ability to have a baby. Therefore, it is important for a patient to seek out an “expert” in the field of reproductive surgery who has specialized training in microsurgical techniques and proven results. A surgeon who operates not only to restore or remove, but someone who is preservation minded, aware of what the consequences of each of their actions can be. A surgeon who realizes that all the “small things” add up, and can make a difference in optimizing the surgical outcome. A surgeon who does not compromise the patient in performing a particular procedure if another would give better results. Sometimes an open procedure, although more invasive, gives a much better outcome than one performed by laparoscopy.

If your doctor has advised you that surgery is necessary and you are planning to have a baby now or in the future, be sure to ask a lot of questions. This includes the way they plan to perform the surgery. How many of these surgeries have they done? What is their complication and success rates? Are they the best qualified to perform this type of surgery? And most importantly, if this particular surgery can affect your future fertility. In my experience, sometimes gynecologic surgeries performed by excellent surgeons can unknowingly result in future difficulties with conception.

In many cases, when fertility preservation is important, it may well be worth seeking a second opinion. Unfortunately, not all insurance companies cover the costs of a fertility specialist, but that should not deter you from speaking with one. It could prove to make a profound difference in your outcome, and although it could be a bit more expensive, it could result in whether or not you will be successful in conceiving.

I look at surgery as an art form. Would you rather have a painting done by the superb skills of Michelangelo where each brush stroke is deliberately done using only the finest technique to create a “masterpiece”, or by an artist that just completes a painting? The choice is yours; and you owe it to yourself to make it the best one.

THE REAL MEANING BEHIND IVF STATISTICS

Patients considering IVF will want to find the clinic in their area with the highest success rates. Many will search the Internet to find the clinic with the “best” statistics. According to our Society, comparisons between clinics must be made with caution. Many times you may not be comparing “apples to apples”. Some clinics may be more willing than others to accept patients with low chances of success or may specialize in various ART treatments that attract particular types of patients. No reported success rate is absolute. A clinic's success rates will vary year to year even if all determining factors are the same. As an extreme example, if a clinic reports only one IVF cycle in a given category, the clinic's success rate will either be 0% or 100%. Some clinics see more than the average number of patients with difficult infertility problems. Some clinics are willing to offer IVF to most potential users, even those who have a low probability of success. Others discourage such patients or encourage them to use donor eggs, a practice that results in higher success rates among older women. Clinics that accept a higher percentage of women who previously have had multiple unsuccessful IVF cycles will generally have lower success rates. In contrast, clinics that offer IVF procedures to patients who might have become pregnant with less technologically advanced treatment will have higher success rates.

Many programs are very aware of the fact that patients will search web sites to find a clinic, in their area, with the highest success rates, and knowing this, may “pad” their reported success rates by refusing to do “certain” patients who may not be the “best statistical candidates”. This includes any patient who has been unsuccessful several times, has experienced decreased response rates with follicle numbers, decreased fertilization rates, decreased number of embryos produced, decreased quality of embryos on a fresh or frozen cycle, have a history of elevated FSH levels, or they are of increased maternal age (greater than 38), they may be “talked out of trying” with their own eggs and only offered the option of donor eggs. By these women not doing IVF using their own eggs, they would not “negatively” affect the clinic's success rates and statistics. Although, Arizona Center for Fertility Studies prides itself on its high success rates with IVF, we are never motivated by our statistics, and feel very strongly that a patient should always have the choice as to whether or not she wants to use her own eggs; no matter if she is not “the ideal candidate”. The use of donor eggs, at ACFS, is a choice, never the only option; and, we deeply respect a woman's right to choose.

A related issue is that success rates shown in this report are presented in terms of cycles, as required by law, rather than in terms of women. As a result, women who had more than one ART cycle in 2007 are represented in multiple cycles. If a woman who underwent several ART cycles at a given clinic either never had a successful cycle or had a successful cycle only after numerous attempts, the clinic's success rates would also would be lowered.

Cancellation rates affect a clinic's success rates. Success rates for unstimulated (or "natural") cycles are included with those for stimulated cycles. Success rates are calculated per cycle rather than per patient. Therefore, for patients who undergo both fresh and frozen cycles, success rates are calculated separately for each cycle. Clinics that have very good live birth rates with frozen embryos would have higher ART success rates if these births were included as successes from the original stimulated cycle. Patients should look at both rates when assessing a clinic's success rates.

The number of embryos transferred varies from clinic to clinic. In 2007 the average number of embryos that a clinic transferred to women younger than age 35 ranged from one to five. Some programs will transfer more embryos to try to improve their success rates. The American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology discourage the transfer of a large number of embryos because it increases the likelihood of multiple gestations. Multiple gestations, in turn, increase both the probability of premature birth and its related problems and the need for multifetal pregnancy reduction.

Arizona Center for Fertility Studies follows the guidelines set forth by our society but reserves the right to occasionally go outside those guidelines, by one embryo, if it is medically indicated and fully discussed with the couple as to the reason why and all possible complications.

At ACFS, we are confident in our experience, as well as the expertise of our embryology lab, and we encourage patients to look at other program's statistics but to make sure that they are “comparing apples to apples” and they ask those tough questions and be sure that the clinic is more interested in the patient's wishes than their own statistics. Although IVF offers important options for the treatment of infertility, the decision to use ART involves many factors in addition to success rates. Going through repeated ART cycles requires substantial commitments of time, effort, money, and emotional energy. Therefore, couples should carefully examine all related financial, psychological, and medical issues before beginning treatment. Location and selection of the clinic is not nearly as important as the women's right to choose, commitment of the entire staff to the overall well being of the patient and a proven record of excellence and high success rates.

SAYING YOU CARE IS ONE THING, CARING IS ANOTHER

It is easy to say that you care, however, if the truth be told, it is a lot harder to back that statement up. There is a number of ways to tell if a clinic “cares”.

1. Do they answer the phone by the 3rd ring and are courteous, polite, warm and engaging or do they put you on hold abruptly and without asking you if it is okay? If you are on hold, do they get back to you in a timely matter?
2. If you call the office during business hours, are you transferred to someone right away or get a call back within several hours or at least by the end of the day? After hours, when you call, is there a simple menu system and does the physician either answer the phone or call you back within minutes?
3. Does the entire office staff genuinely seem interested in you and take a real effort to get to know you?
4. Does every member of the team do what they say they will do?
5. Will they meet you after hours or on the weekends to give you an injection, do an ultrasound because your period started and you have to rule out a cyst before starting medication, or do an ultrasound to check to make sure your baby is doing okay because you are just a bit anxious or had a little spotting, all at no charge?
6. Will they spend as much time as you need to answer questions on the phone or in the office, all at no charge?
7. Will they cry and laugh with you?
8. Do they treat each patient as they would their best friend?
9. Are all members of the team warm, caring and welcoming; and you can call or talk to any of them anytime about anything?

ACFS does all these things and much more; and meets weekly with the entire staff for one and half hours, discussing and reinforcing our commitment to our patients and how we can further improve their care.

THE TRUTH ABOUT MONEY BACK GUARANTEES

At Arizona Center for Fertility Studies, we do not offer a money back guarantee. This is for several reasons:

1. We believe that a money back guarantee is mostly a “marketing tool”. Most patients will not qualify. Even if they qualify and are not successful, they will only get a portion of the money back. Generally, these “guarantees” are for the standard services of IVF and do not include the anesthesia, medications, lab tests, ICSI, AH, PGD and freezing fees (see cryo link) that are associated with the procedure. Clinics will only qualify patients that have the ”best chance” of success.
2. It does not feel ethically right to us at ACFS to have a couple qualify and pay $30,000 plus dollars for a money back guarantee and get pregnant on the first attempt. Normally that one cycle would cost around $10,000, including ICSI and freezing; and they would then be out $20,000 plus dollars. We believe in a fair price for each cycle, where, if the couple needs to do IVF more than once, it is affordable.
3. We are confident in our experience and the expertise of our embryology lab that couples should have a good success with one or two attempts, either using their fresh or frozen embryos.

We are confident enough in our IVF program and committed to the success of our patients, that if you are not successful with two fresh attempts at IVF, including the use of your frozen embryos, we will do a third cycle of standard IVF, using your own eggs, at no charge. The third cycle would have to be done within a year so the laboratory testing would not be too old, and would not include anesthesia if needed for TVA, ICSI, AH, PGD, blastocyst transfer, embryo freezing and medications.

NON-SURGICAL TREATMENT FOR ECTOPIC PREGNANCY

An ectopic or tubal pregnancy occurs when the embryo is not able to get out of the fallopian tube and into the uterine cavity in a timely fashion. In a normal situation, fertilization occurs in the distal end of the tube and the early dividing embryo will spend 4 days or 96 hours in the fallopian tube; at which time, it will quickly travel through the proximal part of the tube and into the uterus. Once in the uterus, it will float free for the next two and a half days, then implant on day 6 1/2. Some woman can have slight bleeding or spotting at this time, known as implantation bleeding. Anything that interferes with the embryo's ability to move down the tube and into the uterus will cause the embryo to “get stuck” where it will either become non-viable or continue to grow in the tube until it causes the tube to rupture and puts the patient at risk of internal bleeding, hemorrhaging and shock secondary to significant blood loss.

Tubal pregnancies occur because of damage to the fallopian tubes, which can be due to a number known or unknown causes. The most common known reasons are: previous infection from pelvic inflammatory disease (PID), STDs like gonorrhea or chlamydia or IUD use, previous tubal surgery, conceiving after having a tubal ligation, conceiving after a reversal of sterilization, external constriction secondary to scarring from endometriosis, and even after an embryo transferwhere the embryo can float into the fallopian tube and can not be brought back down into the uterus by the normal ciliary or hair-like movements of the tube.

In this day and age, an ectopic pregnancy should not be missed, let alone rupture. At ACFS, the philosophy is that every patient has an ectopic pregnancy until proven otherwise. To make sure that the patient does not have an ectopic pregnancy; as soon as any of our patients are late on their periods, even by a few days, they get a urine pregnancy test (at no charge) or a blood pregnancy test, and if positive, are scheduled for an early transvaginal ultrasound at 5 1/2 to 6 weeks, also at no charge. Once the pregnancy is confirmed in the uterus everyone can relax and they are no longer at risk of an ectopic or tubal pregnancy that can rupture and cause internal hemorrhaging. The only exception, is in the case of a heterotopic pregnancy, where are pregnancy can occur both in the uterus and in the fallopian tube. The spontaneous incidence of this is 1 in 25,000; and with IVF, where multiple embryos are transferred into the uterus, the incidence can be as high as 1 in 1000. Although, this diagnosis is more difficult to make and seeing a pregnancy in the uterus makes you think everything is okay; if a patient is at high risk for an ectopic pregnancy, then you always have to think about the possibility of a heterotopic pregnancy.

The diagnosis of a tubal pregnancy is made by having a high suspicion for a patient at risk, no ultrasound evidence of a intrauterine pregnancy, abnormally increasing hCG levels, abdominal pain, vaginal bleeding or ultrasound evidence of a mass or pregnancy outside of the uterus. Once the diagnosis is made there are several treatment options available.

1. Surgery can be done by diagnostic laparoscopy, where a laparoscope is placed through the belly button and into the abdomen under general anesthesia. If diagnosed early enough, you should always be able to save the involved fallopian tube. The procedure is done by first injecting epinephrine into the tissue around the tubal pregnancy to stop any bleeding and then making an incision over the area in the tube where the pregnancy is and allowing the pregnancy to “pop out”. Any small bleeders can be gently cauterized and the tube is left open to heal normally. The thinking being, “once an ectopic, not always an ectopic”, and the involved tube can have the possibility of next time carrying a pregnancy into the uterus. If diagnosed early, you should never have to have a laparotomy or open incision.
2. The other option is to avoid surgery and treat the ectopic pregnancy with methotrexate (MTX), which is a chemotherapeutic agent, that destroys rapidly dividing cells, which is what pregnancy tissue is. If you are uncertain of the diagnosis of an ectopic pregnancy, blood hCG levels are not compatible with a healthy, ongoing pregnancy, but you know that the pregnancy is not in the uterus, then an in-office D&C is recommended. This is done to see if there is any pregnancy tissue in the uterus, which would indicate that you are having a miscarriage based on the clinical findings. The tissue is sent ʻSTAT' to pathology for evaluation. If there isn't any tissue in the uterus, then the only other logical place for it to be is in the fallopian tube. If that is the case, then the treatment options are surgery or MTX. If the diagnosis is made early, as it can be if the thinking is “everyone has an ectopic pregnancy till proven otherwise”, then MTX is a logical option. Three criteria need to be met before using MTX. This includes having the hCG levels under 10,000 IU or less, the patient is having minimum to no symptoms of pain, and if there is a mass outside the uterus on ultrasound, it has to be 3 centimeters are less. Once these criteria are met and with early diagnosis they should be, then MTX can be used to treat and eliminate the tubal pregnancy. It can be given orally for 5 days, given as an intramuscular injection at 50 mg every other day until hCG levels drop by 30% or given in a single dose of 150 mg intramuscularly. Since MTX destroys cells that are dividing rapidly, it can cause gastrointestinal side effects like nausea, vomiting, diarrhea, cold sores and abdominal pain. These are usually mild and do not occur in most patients. By using MTX, you will eliminate the need for surgery. This may decrease the risk of additional compromise to the involved fallopian tube; thus increasing the chance that it will function normally with the next pregnancy. Neither surgery or MTX will guarantee that the involved tube will function normally with the next pregnancy but at least you will be given the possibility. If the ectopic pregnancy has ruptured and the patient is bleeding internally, surgery is the only option and, most of time, if not all of time, the involved fallopian tube needs to be removed, regardless if the other tube is absent or badly damaged. This is why early diagnosis of an ectopic or tubal pregnancy is so important.