Prominent fertility specialists, embryologists and reproductive biologists issue rebuttal and corrections to guidelines issued by the American Society for Reproductive Medicine (ASRM) regarding “mosaic” embryos diagnosed by PGT-A

NEW YORK, NY, February 24, 2021 /Neptune100/ — Preimplantation genetic testing for aneuploidy (PGT-A) is a controversial add-on to in vitro fertilization (IVF) cycles in which embryos, prior to replacement into the uterus, are tested for chromosomal abnormalities and chromosomal-abnormal embryos are excluded from transfer. The hypothesis behind PGT-A has been for over two decades that transfer of only euploid (chromosomal-normal) embryos will improve IVF pregnancy rates and reduce miscarriages. This hypothesis has, however, never been confirmed in clinical practice; yet, the procedure has, nevertheless, been increasingly used by IVF centers and currently is believed to be utilized in close to half of all IVF cycles in the U.S.

Though the American Society for Reproductive Medicine (ASRM) never endorsed PGT-A, it recently issued a formal clinical guidance regarding the interpretation of PGT-A results when those results suggest an embryo is “mosaic.” PGT-A is performed by biopsying embryos at blastocyst-stage and taking on average five cells from the embryo’s outer layer, called trophectoderm. This genetic material is then tested. Results can show the following 3 outcomes: (i) euploid-normal, in which case embryos are perceived to be transferrable; (ii) aneuploid-abnormal, in which case embryos are not to be transferred and, mostly, are disposed of; (iii) “mosaic,” in which the test reveals a chromosomal-normal and one or more chromosomal-abnormal cell lines. Mostly because at least hundreds of chromosomal normal offspring have been born worldwide following transfers of by PGT-A reported as chromosomal-abnormal and/or “mosaic” embryos, the ASRM’s position paper addressed how “mosaic” embryos should be managed.

This press release announces publication of an opinion article by a spontaneously coalesced worldwide group of prominent clinicians, embryologists and biologists in the IVF field, called the International Do No Harm Group in IVF (https://www.donoharmivf.org, since 2020 incorporated in New York City as a not-for profit organization) which is opposed to the introduction of many, mostly unvalidated, add-ons to IVF in recent years. Even though the ASRM initiated their guidance with the statement that their document should not be viewed as an endorsement of PGT-A utilization in all patients, the group’s criticism of the ASRM document argues that publication of guidance on how to interpret a test, by IVF providers and public will automatically be perceived as exactly such an endorsement. Moreover, such an understanding will further expand utilization of an often useless and for many patients even harmful test. The just published manuscript in the medical journal Reproductive Endocrinology and Biology, in addition, corrects several factual errors in the ASRM opinion.

Not addressed in the just published paper is a highly relevant new international development regarding PGT-A: A group of Australian patients recently filed a class action lawsuit against two prominent IVF centers, claiming the mistaken disposal of normal embryos with normal pregnancy potential due to false-positive diagnoses with PGT-A. The subject, therefore, may very well also end up in U.S. courts.

Norbert Gleicher, MD, Executive Director of the IDNHG-IVF is available for further comments by contacting Lydia Dellere at [email protected]. He is also the Medical Director and Chief Scientist at New York’s Center for Human Reproduction, one of the world’s leading clinical fertility and research centers, a Visiting Researcher at Rockefeller University in New York City, a Visiting Professor (Adj.) at the Medical University Vienna, Vienna, Austria and President of The Foundation for Reproductive Medicine, a not-for-profit research and educational foundation in NYC.