What MicroSort® Tells Clinical Trial Participants

Center for Human Reproduction: MicroSort - separation of X and Y-bearing human spermThe Genetics & IVF Institute (GIVF), in Fairfax, VA, which originally patented the MicroSort® gender selection technology, and over many years administered a clinical trial (in which the CHR participated), recently informed all trial participants in a flyer, signed by their Clinical Director, that “GIVF had decided not to (further) pursue FDA approval of MicroSort®.”

The flyer further stated: “this decision was not based upon GIVF having any concerns regarding safety or lack of effectiveness of the MicroSort® technology.” GIVF further pointed out that they, “however, want to be clear that, as a result of this decision, there will be no formal decision by the FDA regarding the safety and effectiveness of the MicroSort® technology.”

This information was the first formal communication that we received from GIVF as to the ultimate fate of Microsoft® after the trial was closed to further participants. Our repeated earlier queries to GIVF were always addressed with suggestion that a formal decision by the FDA was expected.

The first hint at trouble became apparent in April of 2011, when GIVF announced that the FDA had notified them that MicroSort®, as of this moment, no longer could enroll new patients into the ongoing clinical trial for the indication of “family balancing.” The FDA, however, permitted for at least another six months of further enrollment for the indication of “genetic disease prevention for families with increased risk for so-called sex-linked diseases.” Hence, MicroSort® is no longer available for gender selection anywhere in the United States, leaving IVF + PGD as only reliable option.

What happened since, and what made GIVF decide to no longer pursue FDA approval for MicroSort® is unclear. Above noted communication to clinical trial participants is obviously written by lawyers, and not very reassuring in view of its lack of detail, transparency and background information.

The official reason given for the communication was “important information about frozen embryos,” with the following attached recommendations in regards to frozen embryos produced with use of sperm that has undergone MicroSort®:

  • GIVF strongly recommends that such embryos not be transferred to other couples or that any other persons be allowed to use these embryos since any third party  would not have had the benefit of informed consent, using MicroSort.®
  • GIVF also recommends extreme caution transferring frozen embryos to other IVF centers for transfer since they may be unfamiliar with the MicroSort® clinical trial, and “they may not be aware of the research conditions under which these embryos were produced.”
  • Finally, GIVF advised that embryos, produced with sperm sorted by MicroSort for genetic disease preventions should not be transferred to third parties since such embryos have increased risk for genetic disease above the risk in the general population (!!!).

Fortunately, we have no frozen embryos for embryo donation, produced with MicroSort®.  Nevertheless, we (and we are pretty sure our patients who traveled to Virginia for MicroSort®) wish that the communication we received from GIVF had been more transparent.