It took quite some time (many, indeed, believe too much time) for the American Society for Reproductive Medicine (ASRM) to, finally, publish an updated opinion of preimplantation genetic screening (PGS) or, as it is now called in its latest reincarnation, preimplantation genetic testing for aneuploidy (PGT-A).
What the ASRM’s Practice Committee concluded (in much more diplomatic language than CHR has been using in our warnings against PGS), however fully matches with CHR’s longstanding opinion: “The value of preimplantation genetic testing for aneuploidy (PGT-A) as a screening test for in vitro fertilization (IVF) patients has yet to be determined,” which in diplomatic language means that we have been sold a lot of hot air by the genetic laboratory industry over the last two decades because the commercial clinical utilization of diagnostic tests with unknown diagnostic value is not only unethical but, simply, inexcusable!
What makes all of this, however, even worse a transgression, is the by now indisputable fact that, as a consequence of utilizing this test, huge numbers of perfectly normal embryos have been discarded. Because so many healthy embryos were mistakenly disposed of, a large number of patients not only did not benefit from the test but, actually, were harmed in their pregnancy chances by using the test (and paying for it out of pocket because insurance companies usually do not reimburse for PGS/PGT-A). Many among those adversely affected patients, moreover, not only discarded healthy embryos but, involuntarily, concomitantly also discarded their chances of genetic motherhood by wrongly assuming they could no longer conceive with use of their own eggs and, therefore, prematurely opting for donor eggs.
The deafening silence of the genetic laboratory industry, which made millions selling a mostly useless and sometimes harmful test, which now for the second time in a decade has been described by the ASRM as unproven in its ability to affect IVF outcomes, makes this, however, an even larger scandal. The industry not even uttered one “mea culpa” or one “we are sorry” for all the heartache patients encountered for over a decade! Much to the contrary, seemingly without contrition, the industry is, still, pushing the concept of what is now called PGT-A, though, once again, for some new nebulous and unsupported indications. In other words, business is continuing unabated!
Likely not only for the IVF field, but for medicine as a whole, the history of PGS/PGT-A is unprecedented. We are unaware of similar circumstances in any other field of medicine, where a crucial clinical test (ultimately decisive in determining which human embryos should be disposed of) is allowed to enter routine clinical practice without prior validation studies and, indeed, based on completely unsubstantiated claims, is allowed to do this over and over again in three consecutive incarnations of testing technology and interpretation of results.
As repeatedly noted in the pages of the VOICE, CHR has always argued in favor of professional self-regulation in the field of IVF. In doing so, we, however, always referred to ethical considerations affecting research in reproductive medicine that should be left to professional self-regulation. This clearly is not the issue here; to the contrary, the reason why PGS/PGT-A has become such a black eye in the, otherwise, rather stellar history of IVF, is that appropriate research was not performed before the procedure was integrated into routine IVF practice.
Whether a commercial clinical test, especially a genetic test with the power to lead to disposal of human embryos, is properly validated for clinical use has never been subject of self-regulation but has always been under the purview of strict Food and Drug Administration (FDA) guidelines and/or, often, under local state department of health guidelines. How, even up to this point, PGS/PGT-A has been able to avoid FDA and/or local department of health scrutiny, is truly astonishing. How much more damage must be done to infertile couples before the FDA and/or local state health departments intervene?
This is a part of the April 2018 CHR VOICE.
Norbert Gleicher, MD, leads CHR’s clinical and research efforts as Medical Director and Chief Scientist. A world-renowned specialist in reproductive endocrinology, Dr. Gleicher has published hundreds of peer-reviewed papers and lectured globally while keeping an active clinical career focused on ovarian aging, immunological issues and other difficult cases of infertility.
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