Genetics & IVF Institute Decides to End Clinical Trial
of MicroSort Sperm Separation Technology

Clinical Trial Treatment Phase Ended; Premarket Approval Will Not Be Pursued

FAIRFAX, VA -- Although more than 1341 babies have been born during the clinical trial of MicroSort(R) gender selection technology, the Genetics & IVF Institute (GIVF) has chosen to end the clinical trial being conducted under an FDA Investigational Device Exemption (IDE) and not pursue premarket approval for the device. The company board of directors made a decision that the cost and regulatory burdens associated with continuing the clinical trial were too high for a business the size of GIVF.

MicroSort was used before conception to sort sperm into populations that either primarily produce girls or those that primarily produce boys. Most couples in the clinical trial requested a girl. Clinical trial results to date reveal that when girls were requested, 93% of couples had a baby girl. When a baby boy was requested, 85% of couples had a baby boy. Sperm sorts and clinical procedures are no longer being performed, but some patients are now pregnant. Final numbers will be calculated when the remaining babies conceived during the trial are born.

Couples were eligible to participate in the MicroSort clinical trial for one of two reasons: to avoid having a child with one of the approximately 1500 sex-linked and sex-limited genetic diseases, including Duchenne muscular dystrophy and hemophilia, or to balance their families. To qualify for the family balancing arm of the trial, a couple must already have had at least one child of the sex opposite to what they were seeking through MicroSort. To seek a girl through MicroSort, for example, they would have to already have at least one boy.

The Genetics & IVF Institute provides infertility treatment, genetic services, donor gametes and more. Since its inception in 1984, GIVF has been responsible for nearly 26,000 pregnancies worldwide.

Summary of MicroSort Clinical Trial Results

There have been 4982 couples enrolled in the MicroSort clinical trial and 1341 babies have been born from IUI and IVF/ICSI procedures employing MicroSort sperm. Most couples desired family balancing (92%) and most couples desired a daughter (67%). For couples who became pregnant with MicroSort sperm, 93% of those who desired a girl baby got a girl baby and 85% of those desiring a male baby got a male baby. The most recent clinical trial results reported to the FDA (summarized in the report available here) showed that sorting resulted in a significant and biologically meaningful shift in the percentage of X- and Y-bearing sperm in the sorted sample. Sorting shifted the X:Y ratio from 50:50 in unsorted sperm to an average of 87% X-bearing sperm after XSort and 74% Y-bearing sperm after YSort.

MicroSort sperm used in IUI and IVF/ICSI cycles resulted in rates of fertilization, cleavage, and clinical pregnancy that are consistent with those reported in the reproductive literature. Likewise, the rates of spontaneous clinical abortion are consistent with those reported for the general population. Furthermore, the rate of major congenital malformations (birth defects) among babies born from MicroSort sorted sperm is similar to those reported for the general population. We are pleased to have been able to help these many couples achieve their dreams of preventing sex-linked / sex-limited genetic disease in their children or balancing their families.

Special Offer for MicroSort Clinical Trial Enrollees

In recognition of any inconvenience that the termination of the MicroSort clinical trial may cause for some patients, The Genetics & IVF Institute (GIVF) is offering a discount for certain Preimplantation Genetic Diagnosis (PGD) services to couples who had completed their enrollment in the MicroSort trial. The PGD services will be delivered at the GIVF clinic in Fairfax, Virginia, just outside Washington, DC. The discount is for 25% off either a two probe PGD test (to determine X and Y chromosomes) or the more expansive 24 chromosome genetic test. To qualify, couples must have been enrolled in the MicroSort trial. Read more about PGD at GIVF here.

For more information or to request a consultation with a GIVF physician, please use our online form, found here or call (800) 552-4363.

If you were enrolled in the MicroSort clinical trial and have questions, please use the form found here to send us a message.