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Unsorted semen specimens contain approximately 50% X- and 50% Y-bearing sperm. Data from the clinical trial indicate that MicroSort technology has increased the proportion of X-bearing sperm to 88% on average* in the enriched X-sorted sample (XSort®), and the proportion of Y-bearing sperm to 73% on average* in the enriched Y-sorted samples (YSort®). It is important to note that the current technology does not result in the complete exclusion of either X- or Y-bearing sperm from the final sperm preparation.

MicroSort offers sperm separation with IVF or IVF/ICSI at our clinical facility in Fairfax, Virginia. (IUI is not currently being offered at the Fairfax facility. The MicroSort® website will be updated if and when this becomes available in the future.) If you cannot travel to Fairfax, Virginia, your semen sample may be sorted in the MicroSort laboratory in Fairfax, Virginia, frozen, and shipped to a collaborating medical facility for use in an IVF or IVF/ICSI procedure. Donor sperm from Fairfax Cryobank is also available for sorting under certain circumstances. The MicroSort process is currently in an FDA clinical trial. Couples who would like to participate in the clinical trial will need to qualify for the clinical trial. If eligible to participate, they will also need to take part in an informed consent process before the MicroSort sperm sorting can be scheduled.
MicroSort® Clinical Trial Obtains Limited Continued Access Permission

Continued Focus on FDA Approval efforts

The FDA has granted GIVF permission to allow, on a limited basis, enrollment of new participants in the MicroSort® clinical trial. This limited continued access does not represent FDA approval of MicroSort®, but does allow us to continue to offer the MicroSort® technology under the clinical trial while the PMA is being prepared for and reviewed by FDA.