Slow FDA decision affects Gender Selection in the U.S.

Oct. 1, 2010 - PRLog -- (October 1st, 2010) New York, NY – Whether elective gender selection should be offered to the public has been especially controversial since 2001, when the Ethics Committee of the American Society for Reproductive Medicine (ASRM) declared gender selection “ethical” in principle.  At the time, The Center for Human Reproduction (CHR), after lengthy discussions amongst members of its own Ethics Committee, disagreed with ASRM’s decision because it supported pre-fertilization gender selection via semen sorting but opposed post-fertilization gender selection by in vitro fertilization (IVF) and preimplantation genetic screening (PGS), if done as an only reason for IVF.

CHR’s Ethics Committee, in contrast, concluded that it was never ethical to withhold a more accurate methodology from the public (IVF+PGS is significantly more accurate in selecting gender than semen sorting), and felt strongly that patient rights to self-determination outweighed concerns raised by ASRM’s Ethics Committee.  

CHR communicated this difference in opinion in an exchange of correspondence with the ASRM and later in a publication in Fertility & Sterility, the official publication of the ASRM (Gleicher N, Karande V. Gender selection for nonmedical indications. Fertil Steril 2002;78:460-2).

Since then, semen sorting, utilizing a patented methodology called Microsort™, and in selected circumstances IVF + PGS, have co-existed in the U.S. in clinical practice. To become the first sperm sorting technique with Food and Drug Administration (FDA) approval, the inventors of Microsort™ conducted a clinical trial in cooperation with a number of infertility centers to establish safety and efficacy of the methodology. Some centers, including CHR, offered IVF+PGD in parallel, mostly for family balancing purposes and (in compliance with ASRM guidelines) when other indications for IVF co-existed.

The Microsort™ trial was completed over a year ago but a FDA decision has still not been reached/published. Until such a decision (it is presently unknown when that will be), patients in the U.S. have no effective sperm sorting methodology available for pre-fertilization gender selection. Other sperm sorting methodologies offered “on the street” or via the Internet have never been proven effective in changing the ratio of X and Y spermatozoa.

This means that, at present, the only effective gender selection methodology available in the U.S. is IVF+PGS, also the most accurate method, with approximately 99% accuracy.

CHR is among only a small number of fertility centers offering to qualified couples gender selection by IVF + PGD. Amongst those centers, only very few offer PGS in-house, as CHR does. Almost all centers send cells, taken off embryos, for analyses to specialty laboratories. By performing this laboratory analysis in-house, CHR avoids the need for overnight transportation of these valuable biological products.

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About Center For Human Reproduction
CHR (www.centerforhumanreprod.com) is a nationally and internationally renowned clinical fertility and research center, located in Manhattan, New York City. It has been offering IVF+PGS for gender selection purposes since 2002, and recently reported on the impact of ethnic backgrounds in the U.S. on choices made with gender selection (Gleicher N, Barad DH. The choice of gender: is elective gender selection, indeed, sexist? Hum Reprod 2007;22:3038-41). (DISCLOSURE: CHR participated in the Microsort™-Consortium. Neither CHR nor any of its employees, however, either received or are scheduled to receive financial benefits from Microsort™)