First class-action lawsuit because of PGT-A
One could argue that a class-action lawsuit regarding preimplantation genetic testing for aneuploidy (PGT-A) had to happen sooner or later. If something is surprising, then it is that it happened in Australia, and not in the U.S. Monash IVF in Melbourne, one of the world’s pioneering IVF centers, and a second IVF center in Adelaide were sued in the Supreme Court of Victoria state on behalf of over 100 claimants (plaintiff attorneys expect that number to grow to approximately 1000 patients) who underwent IVF cycles with PGT-A between May of 2019 and October of 2020.
According to press reports, plaintiffs’ claims are that the two IVF centers may have incorrectly classified potentially healthy embryos as abnormal and, therefore, mistakenly discarded healthy embryos, thereby robbing patients of their chances of having children.
Interestingly, it appears that these two IVF centers used the most recent version of PGT-A, so-called non-invasive PGT-A (niPGT-A), which THE VOICE addressed in the December 2020 issue, at the time still unaware of this class-action lawsuit. We then made the argument that practically all published studies (but one) reported even more unreliable outcomes with niPGT-A than had been reported with standard PGT-A which, as also repeatedly discussed in THE VOICE before, in CHR’s opinion is a basically useless test that does not improve IVF outcomes and, in many patients, reduces the chance of pregnancy.
In this December article, we also noted that several IVF centers in the U.S. had started offering ni-PGT-A as a routine test in association with IVF and expressed CHR’s opinion that using niPGT-A, a not only unvalidated test, but a test clearly inferior to the already useless (and potentially harmful) standard PGT-A, was in our opinion inexcusable.
Monash IVF suspended use of the niPGT-A test in 2020 after supposedly having used it in up to 13,000 cycles. Media reports have not informed whether the center reverted to standard PGT-A or stopped all PGT-A. CHR, of course, has for years argued against most utilizations of PGT-A in association with IVF. It has been CHR’s opinion for years that all PGT-A (and its earlier versions called preimplantation genetic screening, PGS), to quote the plaintiffs in the Australian class action, routinely incorrectly classify potentially healthy embryos as abnormal and that IVF centers, therefore, routinely discard healthy embryos, thereby robbing patients of their, often, last chance of having children.
It is important to point out that the filing of a class action, of course, does not establish guilt of the defendants. That Monash suspended niPGT-A testing, however, speaks for itself!
IVF and society
Two recent publications addressed important societal issue regarding IVF. A first from Australia argues for the logistic confluence of two major trends in IVF, the increasing utilization of “planned” oocyte preservation for extended fertility preservation and the in parallel increasing demand for donated oocytes by infertility patients but also other social groups (older single women, gay men, etc.; Polyakov and Rozen, BMJ Ethics 2021;http://dx.doi.org/ 10.1136/medethics-2020-106607).
The literature suggests that a large majority of frozen eggs for the purpose of ‘planned’ fertility preservation will never be used. The two authors, therefore, suggest that, “donation of oocytes originally stored in the context of “planned” egg banking, with appropriate compensatory mechanism, would ameliorate futile banking concerns, while simultaneously improving the supply of donor oocytes.” They further concluded that, “this proposed arrangement will result in tangible benefits for prospective donors, recipients and society at large.”
CHR loves this proposed concept and is hereby announcing the center’s willingness to accept good quality eggs from women who cryopreserved their oocytes at younger ages and no longer have any use for these eggs. CHR, indeed, is even willing to reimburse qualified women for some of the expenses incurred while freezing their eggs and will be responsible for the expenses in moving those eggs from their current location to CHR. Women considering such an option are encouraged to call The CHR at 1-212-994-4400 to make a free appointment with a CHR physician to determine whether they qualify for such a donation.
The second article that attracted our attention was written by Sarah DeWeerdt, a freelance science writer, and asked the question (regarding infertility treatment), “how much is a baby worth?” Nature 2020;588:S174-176.
Though published in Nature, likely the world’s most prestigious science journal, we were somewhat disappointed by some of the opinions expressed by the author; but we found the timing of this article and its overall gist highly appropriate and well expressed by the subtitle of the article: “Access to fertility treatments is limited by the cost in both high- and low-income countries. But new technologies and attitudes aim to fix that.”
As repeatedly expressed in these pages, CHR opposes most of so-called “add-ons” to IVF and we, therefore agree with DeWeerdt wholeheartedly that there is little evidence that most of them improve treatment outcomes for infertile patients. The article quotes a colleague and friend of CHR, Jonathan Van Blerkom, PhD, a scientist at the University of Colorado in Boulder, as making the correct argument that, “the natural inclination is, well, it costs more, it must be better; and that is not necessarily true.” Another scientist is quoted in the article as saying that, “the vulnerable are preyed on” and, “a lot of infertile couples pay much more than they should.”
CHR, of course, fully agrees with all of these sentiments but cannot agree when DeWeerdt concludes that, “the advantage of mild stimulation is not only the cost-saving but also better health outcome. She likely reached this opinion after interviewing Prof. Geeta Nargund, MD from St. Georges University Hospitals in London, UK, and the CREATE Fertility network of IVF centers, who has become the world’s most prominent proponent of so-called mild ovarian stimulation in IVF. Paradoxically, mild stimulation is exactly one of these clinically unvalidated recent “add-ons” to IVF that have resulted in worldwide declines in IVF pregnancy and live birth rates. Moreover, since after female age, egg and embryo yields in an IVF cycle are the second most important predictors of IVF cycle success, the concept of mild ovarian stimulation simply is illogical. While we, here at CHR, hold Prof Nargund in very high regard for much of the scientific work she has produced in the IVF field, we cannot agree with her preference for mild stimulation. It, simply, does not make sense statistically and economically for patients, though it does increase the income for IVF centers.
Norbert Gleicher, MD, FACOG, FACS
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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