IVF Add-Ons: Scientific, Ethical, Regulatory, and Legal Considerations

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Delve into the world of IVF add-ons with Dr. Norbert Gleicher as he discusses the scientific, ethical, regulatory, and legal aspects. Explore the history of abnormal embryo transfers and the outcomes from such procedures, questioning the use of PGT-A in IVF treatments.

  • IVF Add-Ons
  • Ethical Considerations
  • Regulatory Issues
  • Legal Aspects
  • Abnormal Embryo Transfers

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  1. IVF ADD-ONS: SCIENTIFIC, ETHICAL, REGULATORY AND LEGAL CONSIDERATION Norbert Gleicher, MD Norbert Gleicher, MD Medical Director and Chief Scientist, Center For Human Reproduction, New York, NY President, Foundation For Reproductive Medicine, New York, NY Guest Investigator, Rockefeller University, New York, NY Professor (Adj), Department Of Obstetrics & Gynecology, Vienna University School Of Medicine, Vienna, Austria Petrie-Flom Center, Harvard Law School | Cambridge, MA | November 10, 2020

  2. Conflict Statement Dr. Gleicher is listed as co-inventor on a number of pending patent applications claiming diagnostic and therapeutic benefits from determination of CGG repeat numbers and ovarian FMR1 genotypes and sub-genotypes. Dr. Gleicher is co-inventor of awarded U.S. patents, claiming therapeutic benefits for supplementation of DHEA in women with diminished ovarian reserve, a topic discussed in this talk. Other patent applications in regards to DHEA and other fertility-related claims, with no relationship to this talk, are pending. Dr. Gleicher receives royalties from, and owns shares in Fertility Neutraceuticals, LLC, a distributor of a DHEA product. Dr. Gleicher is co-inventor of three pending patent applications claiming potential therapeutic benefit for anti-M llerian hormone (AMH) in infertile women. Dr. Gleicher owns shares in OvaNova Laboratories, LLC.

  3. THERE ARE MANY GOOD REASONS WHY PGT-A SHOULD NOT BE USED IN ASSOCIATION WITH IVF; BUT NONE IS MORE CONVINCING THAN HEALTHY LIVE BIRTHS FROM THE TRANSFER OF ABNORMAL EMBRYOS DESTINED FOR DISPOSAL.

  4. THE HISTORY OF TRANSFERING ABNORMAL EMBRYOS Gleicher et al ASRM 10/2015 Greco et al, N. Engl. J. Med 11/2015 Hundreds of chromosomal-normal offspring born worldwide -Patrizio et al 2019 Not a single chromosomal-abnormal child born

  5. TRANSFERING CHROMOSOMAL ABNORMAL EMBRYOS, PREVIOUSLY DENIED TRANSFERS

  6. OUTCOME SUMMARY 2017-2020 50 couples 249 embryos ( abnormal ) refused transfer 40 patients had transfer of 112 embryos Mean age 42.4 3.7 years

  7. OUTCOME SUMMARY cont. 15 clinical pregnancies (37.5%) 6 normal offspring (15.0%) 7 first trimester losses (17.5%) 3 second trimester losses after amniocentesis (8.75%) 137/249 (55.0%) of embryos still available Ion transfer

  8. CONCLUSION The value of transferring chromosomal-abnormal embryo appears established The value of PGT-A as a diagnostic test appears, however, further diminished

  9. CHR Staff (* Visiting Scientists) Affiliates Rockefeller University: Ali Brivanlou, PhD, MD David F Albertini, PhD* David H Barad, MS, MD Ali Brivanlou, PhD, MD* Sarah Darmon, PhD, MS* Norbert Gleicher, MD Jianjun Hu, MD, MS Emanuela Molinari, PhD Pasquale Patrizio, MD, MBE* Aya Shohat-Tal, PhD* Andrea Weghofer, PhD, MS, MBA, MD* Mia Yang, PhD* Yao Yu, PhD* Salk Institute for Biological Studies: Pradeep Reddy, PhD

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