This is the 6th in a series of 10 responses to common questions/concerns about IVF

#6: How do I choose the right RE and IVF program?
(Note: This is a re-post of an article I wrote in March 2010, that addresses this question in depth)

The process of selecting an IVF program is significantly different from that of choosing a gynecologist, whose credentials alone usually provides a high degree of assurance of adequate knowledge and expertise.

The difference between a poor and a good IVF program may have nothing to do with availability of expertise, equipment, or technical know‑how. It may simply be the way in which the components are put together. In the case of a poor program, all the components may be in place, including technical expertise, but the program may be so poorly administered that there is no uniformity of outcome. An IVF program that doesn’t have a standardized set protocols and procedures might, with luck, come up with some good outcomes over a period of time. These may be characterized by some good results in simple cases and worse results in difficult cases, with no consistency in IVF success rates.

Though the components may be the same, a consistently successful IVF program will, based on individual requirements determined beforehand, arrange those components differently. A consistently successful IVF program can repeat the same recipe for success over and over, and still adopt a reliable format for cases whose special circumstances require a special approach. The only time change would be called for would be with the introduction of new technology that improves the process.

So, when it comes to choosing an IVF program, the patient/ couple should evaluate more than the expertise of just one person. The overall affability, accessibility, competency, expertise and success of the entire IVF team must be taken into account.

The ultimate litmus test of quality contol is “outcome”. Sadly, when it comes to assessing and comparing IVF outcomes in different programs, the patient/couple is largely on its own. This is because IVF outcome statistics as presently published annually by the Centers for Disease Control (CDC) and the Society for Assisted Reproductive Technology (SART) are unaudited and are not even not independently validated. Simply stated, they are unreliable!

Be that as it may, it is important for prospective IVF candidates to feel comfortable and confident about their choice of an IVF program . What then are the parameters that should be considered in the process of making the important decision of choosing an IVF program?

• Outcome (results) – there should be a track record that is consistent with currently accepted IVF success rates
• Caring – the degree to which the couple perceives an attitude of caring manifested by the staff
• Staff Interaction – whether there is an open, harmonious interaction among the staff involved in the program, and whether the couple feels comfortable dealing with the staff
• Reputation – how the program is regarded by consumers, by those who have undergone IVF, by the community at large, and by other physicians

The most important determinant of the quality of an IVF clinic is the manner in which the program processes new patients and how it operates from the time of initial contact until discharge. In order to properly research individual IVF programs, a patient/couple should learn to understand and interpret the terms and statistics used to report results.

The word pregnancy often means different things to different people. For example, the terms chemical pregnancy and clinical pregnancy are frequently used interchangeably, although they have completely different meanings. It’s necessary to understand both of these definitions in order to avoid misinterpreting the statistics that may be quoted.

Chemical Pregnancy: Chemical pregnancy refers to biochemical evidence of a possible developing pregnancy. Provided that the woman has not received the hormone hCG recently, a “positive” blood or urine pregnancy test confirms the existence of a chemical pregnancy .

Clinical Pregnancy: A clinical pregnancy is one that is confirmed rather than merely presumed, as is the case with a chemical pregnancy. A pregnancy can be confirmed when clear evidence of a gestation in the uterus or in a fallopian tube is detected by ultrasound, and/or when pathological evidence of placental or fetal tissue is obtained following miscarriage or surgery. A blood or urine hCG test alone is not sufficient to confirm a clinical pregnancy.

Less than half of all naturally conceived pregnancies survive long enough to postpone the menstrual period. This serves to illustrate that most chemical pregnancies in fact do not progress to clinical pregnancies.

The term chemical pregnancy when applied to IVF might mean one of three things:

1. The embryo started to implant but will not progress to a clinical pregnancy (the most likely scenario)
2. The implanting embryo is in the process of developing into a clinical pregnancy or;
3. The “positive” test ws caused by residual hCG remaining from the pre-egg retrieval “trigger” shot.

Reputable IVF programs do not include chemical pregnancies in their statistics. At the very least, they will only report clinical pregnancies. Ideally, IVF outcome should be reported using live births as the end point. Following are terms that are found in success rate reporting data:

Birth Rate per Embryo Transfer Procedure: This refers to the birth rate per embryo transfer, regardless of the number of embryos transferred per attempt. However, the use of this statistic often overstates the success rate because it excludes those cases where no eggs could be obtained or none of the retrieved eggs successfully fertilized in the IVF laboratory…so that the woman did not undergo an embryo transfer. Conversely, when it comes to reporting outcome following frozen embryo transfers (where success can only be measured in terms of the outcome following embryo transfer) it is quite appropriate to report birth rate per embryo transfer procedure.

Birth Rate per Egg Retrieval: This is another relatively reliable way of reporting IVF outcome because once the woman has undergone egg retrieval, she clearly is a committed IVF patient and should be included in the statistics. However, this statistic may also overstate success rates, because a woman may undergo a fresh embryo transfer along with one or more frozen embryo transfers from a single egg retrieval.

Birth Rate per Number of Women Undergoing IVF (rather than per IVF treatment cycle initiated): Some IVF programs base their outcome statistics on the number of women who undergo the IVF procedure. However, to report birth rate in this manner further inflates (overstates) results because this method fails to take into consideration those cases (women) who undergo more than one IVF procedure. Thus, if the number of patients rather than the number of egg retrieval procedures performed is used as the statistical base, the success rate will naturally look better.

Birth Rate per Embryo Transferred: Although this is not the most common way of expressing IVF results, it is probably the most reliable indicator of IVF success. Using this statistic is preferable to the more commonly used statistic of Birth Rate per Embryo Transfer Procedure because many IVF programs limit the number of embryos transferred per procedure in order to reduce the incidence of multiple pregnancies. Accordingly, using Birth Rate per Embryo Transferred prejudices those more responsible programs that restrict the number of embryos transferred to only one or two at a time in order to minimize the risk of multiple pregnancies.

As an example: If IVF program (A) transfers an average of one 1-2 embryos to women under 35 years of age while program (B) transfers three 3-5, then the relative competency of the two programs cannot be compared using their overall success rate. Here, the number of babies born per embryo transferred would provide a much more reliable measure of performance than would the overall birthrate per embryo transfer procedure.

The recent introduction of embryo selection based upon complete egg/embryo chromosomal evaluation or karyotyping (predominantly using Comparative Genomic Hybridization [CGH]) has increased the baby rate per embryo to more than 60%. Clearly this has moved the agenda forward in the direction of single embryo transfers, thereby reducing the high financial and human cost associated with multiple births.

Establishing Reliable Criteria to Measure IVF Success Rates
Because of the variability of reporting criteria, it is important to establish consistent and comparable measurements for clinics to report their “success” rates. For example, should clinics use clinical pregnancy or live birth as the end point of measurement? Since at least 15% of pregnancies will be lost through miscarriage (the rate will inevitably increase with advancing age of the woman so that by the mid 40′s it could excede 40% ), quoting IVF results on the basis of success rate per clinical pregnancy would be higher than were success rates based on live births to be used. Moreover, since success is also linked to the number of embryos transferred, it is (as stated above) preferable to express results in terms of outcome per embryo transferred.

To be meaningful, any parameter used to assess IVF outcome (success rate) should take into account the “complexity” of the cases evaluated so as to differentiate between “easy” cases and more difficult cases. Other important variables that affect outcome are:

• Ovarian Reserve (as assessed by FSH, AMH, inhibin etc.)
• Number of prior IVF failures
• Cause of infertility

As an example, a woman of 39 years undergoing her 1st IVF attempt, who has normal ovarian reserve, a fertile male partner, and whose indication for IVF is blocked Fallopian Tubes, is more much likely to conceive than is a 28 year old who has had 3 prior IVF failures, diminished ovarian reserve, and whose cause of infertility is endometriosis with immunologic implantation dysfunction (IID).

The variation in statistics are profoundly influenced by the definitions used to describe IVF outcome. A program that reports a 60% birth rate per woman treated will count more than one attempt by the same woman as a single IVF, and thus falsely inflate their success rate. A program quoting a 40% birth rate based on the number of egg retrievals performed might report 50% per embryo transfer procedure while its birth rate per embryo transferred might only be 20% . No wonder it is so important to be able to interpret these statistics intelligently. Imagine how these rates could be manipulated even further if the program were to include clinical or chemical pregnancies in its computations.

SART/CDC IVF Outcome Results are Seriously Flawed
Currently, the CDC and SART report IVF success rates in age categories only. This is illogical because, although age impacts egg quality and adversely influences IVF outcome, it is not by any stretch of the imagination the only factor.

Finally, the results reported must be honest. The only way this can be insured is through validation by independent audit. Sadly, neither the SART nor CDC audits subcategorize clinic specific data in terms of “categories of complexity.” Nor are any of the results they report independently verified. Frankly, consumers deserve better!

Don’t Be a Sucker
There is tough competition in the IVF arena and consumers cannot fully rely on the self-generated IVF success rates reported by SART/CDC. It is still a matter of “consumer beware!” Remember, regardless of its microscopic grade, the implantation rate of a non-genetically selected embryo (even when derived from the egg of a young healthy woman and the sperm of a fertile man), is at best around 30%. So when an IVF program quotes a 60% or better baby rate after conventional in vitro fertilization…BE HIGHLY SUSPICIOUS!

If, for the sake of argument, we were to accept a 35-37% IVF birth rate for young U.S. women as reported recently by CDC/SART as being accurate, then it would be reasonable to expect the IVF program you are considering using to achieve that level of success.

We strongly recommend that when asking for success rates, the researching couple should hold IVF programs accountable by requesting that they provide all statistics in written form. It is also helpful to ask for long term statistics (two to three years’ worth) to account for the effect of turnover in key staff members that frequently occurs in many IVF programs.