PLEASE TAKE NOTE:

MicroSort® Clinical Trial Reaches Birth Limit

Effort Now Focused on FDA Approval

The MicroSort® Division of GIVF has now reached an important milestone in our effort to have MicroSort® approved by the FDA and made more widely available. The maximum number of MicroSort procedures that are allowed under the protocol has been reached, and we have requested that the FDA grant us permission to provide continued access to the MicroSort® technology. If permission to proceed is granted by the FDA, this step would not represent FDA approval, but would allow us to operate under the same rules as the clinical trial.

We will provide more information on this web page as we work through the necessary procedures and as we receive feedback from the FDA with regards to our request for continued access. If you wish to be notified of any changes in the status of MicroSort® procedures, we invite you to sign up for MicroSort® eNews by clicking here. Any news and/or updates about MicroSort will be sent via email to those signed up for MicroSort® eNews.

For those requiring a family balancing option now, please click here to learn about PGD family balancing at the MicroSort® price point.

MicroSort^® General Information

The Genetics & IVF Institute is offering couples the ability to increase the chance of having a child of the desired gender to reduce the probability of X-linked diseases or for family balancing. Utilizing new flow cytometric separation technology, the X (female) or Y (male) chromosome-bearing sperm can be sorted and the enriched fraction of sorted sperm used to achieve pregnancy.

Semen specimens contain approximately 50% X- and 50% Y-bearing sperm. If the proportion of either X- or Y-bearing sperm is increased, the chance of having a child with the desired sex should be correspondingly increased. MicroSort technology currently provides an average increase in X-bearing sperm to 88% (determined by DNA analysis) in the enriched X-sorted sample (XSort®).  The content of Y-bearing sperm is increased to an average of 73% (determined by DNA analysis) in enriched Y-sorted samples (YSort®). The current technology does not result in the complete exclusion of either X- or Y-bearing sperm from the final sperm preparation. DNA analysis by fluorescence in situ hybridization (FISH) can be performed on a portion of the sorted sample to indicate its percentages of the different sperm cells.

MicroSort offers sperm separation with IUI,  IVF or IVF/ICSI at our clinical facility in Fairfax, Virginia. 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 and its use by couples requires their informed consent.

For additional information please read the FAQs (frequently asked questions), related Journal Publications, and News Articles. Information for using MicroSort can be obtained by viewing the How to Use MicroSort page.

Frequent contact between MicroSort staff and couples participating in the clinical trial is essential for obtaining important information about your participation in the clinical trial.

We apologize for any inconvenience or alteration in plans caused by these necessary steps. We look forward to providing continued access, if and when our request is approved.

* Couples who are already in cycle, and have been approved to proceed under the clinical trial will not be affected

In order to support the ongoing data collection, GIVF requests that all previous MicroSort® clinical trial participants who have become pregnant contact us with information regarding your pregnancy or your child. This information is required for the FDA application. It is critical that we hear from you if your contact information has changed. If you have any questions directly related to MicroSort®, please call: 1-800-277-6607, 703-876-3897 or email microsort@givf.com.