Why is it that the same couple walking into two different In Vitro Fertilization (IVF) clinics in the United States could face live birth rates that may be 3 times higher in one program than in the other? The reported national average birth rate for IVF in women under age 39, using their own eggs, is about 33% per egg retrieval procedure, so why does this statistic range from single digits in “poorer programs” to more than 50% in the best ones?
It should be reasonable to expect that professional bodies who are required by law to publish IVF success rates, would act responsibly by reporting accurate and validated results. How else would consumers be able identify and select an IVF program on the basis of their track record?
The unfortunate reality is that SART does not use independently verified systems to compute IVF outcomes. To make matters worse, SART reports aren’t presented until 2 years after the fact, so a woman looking at the most recently published stats today would be seeing data from 2 years ago. What’s more, the success rates are classified using a single variable – the woman’s age. This does not take into consideration a myriad of other variables that can and do influence IVF outcome. As a result, even if one were to make a leap of faith and accept the statistics as being accurate, the manner and timing of their presentation would confound any attempt to interpret them reliably.
Sadly, in spite of more than seventeen years of false starts and (broken) promises, SART/CDC have yet to provide consumers and health insurance providers with verified clinic-specific IVF-outcome statistics. Presently, member programs are free to submit self-generated IVF statistics to SART for reporting. These governing bodies have agreed to report and publish such data regardless of the fact that they have not been audited, independently validated or even properly reviewed. While most IVF physicians are honest and make best effort to generate and submit accurate results, some take advantage of the lax and poorly regulated situation and inflate their results in an effort to better position themselves in the highly competitive US IVF market.
Unfortunately, given the absence of enforceable guidelines it is a simple matter for such unscrupulous practitioners to overstate the number of IVF successes while understating the number of failures. It would be just as easy to bolster success rates by selectively turning away more difficult cases (e.g. women with diminished ovarian reserve, older women and those with a history of repeated failures).
In response to public outrage and numerous complaints regarding exploitation and unscrupulous practice in the arena of infertility (and IVF specifically), the United States Congress took action in 1986. Hearings were held under the auspices of the Office of Technology Assessment (OTA) to address consumer concerns. The proceedings and the conclusions were revealed in the “Wyden Report” (later published in 1989). Congress subsequently mandated—under threat of prosecution—that all IVF programs in the United States report their IVF outcome statistics for 1987. As a result, IVF clinic-specific outcome statistics were published for the first time. This was followed by passage of the “IVF Success Rate Certification Act of 1992” which was implemented in 1997. The explicit intent of this act was to compel honest disclosure of IVF success rates and provide quality assurance of all IVF programs in the United States.
Under this congressional directive, SART was ordered to implement “model quality assurance criteria” with respect to all of its member programs. The three main components of quality assurance are structure, process, and outcome, with the latter being the litmus test. What transpired was that by the government being persuaded to focus on structure and process, rather than on outcome, a great deal of pressure was taken off IVF programs to improve their success rates. Simply stated, the basic intent of the IVF Success Rate Certification Act of 1992, (i.e. to ensure “honesty in reporting IVF outcomes”) was thereby usurped.
In 2002, Robert G. Brzyski, M.D., Ph.D, then President of SART, sent a letter to the medical directors of each member program. In this letter, the medical directors were informed that insufficient funds were available for SART to do random onsite audits of its member IVF programs and that as such, the SART report for the year 2000 would have to be based on “good faith” self-generated results. Medical directors were accordingly asked to review ten sets (10) of their patient records (to be pre-selected by SART) and using a standard reporting format, to submit these to SART. Assurance was given that by doing so, their IVF programs would be automatically certified for the year, 2000. The letter went on to say that future yearly certification would be based on a similar approach.
What needs to be recognized is that insurance companies that pay for IVF services are probably completely oblivious to this subterfuge. Remember, most insurance companies, in an attempt to be confident that participating IVF programs are able to achieve “acceptable success rates,” require that these programs provide evidence that they are members in good standing of SART. In doing so, they are unwittingly urging even dissenting IVF programs to be party to what only represents ongoing process of subterfuge.
So what can be done? Whether by commissioning outside auditors or by mandating the use of a uniform software package that would allow for auditing success rates in real time, with proper intent and commitment it is indeed possible to provide honest and independently verified IVF outcome statistics. At SIRM, we use a proprietary database called the Outcome Based Reporting System (OBRS) that tracks success rates by many different variables including age, baseline FSH levels, the aggressiveness of the stimulation protocol needed to achieve an optimal yield of follicles and eggs and the number of prior IVF attempts. Thus, we can give much more accurate estimates of a woman’s potential for success looking at data from past patients with similar characteristics.
Consider the fact that largely because of the cost and the absence of insurance coverage, less than 10% of women/couples who require IVF receive it. It is my personal position that this current “sorry situation” should be addressed as a matter of urgency, even if as a last resort it would require government regulation to do so.
Any discussion of the worthy and lofty emerging ethical issues currently being debated with regard to issues such as gender selection, medical cloning, etc., all lead nowhere unless the issues of accountability and honesty in IVF outcome reporting figures at the forefront. Consumers have the right to have access to such information.