PLEASE TAKE NOTE:

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.

The clinical trial's eligibility requirements and enrollment procedures to access MicroSort^® will apply to continued access patients. Clinical trial forms, procedures, and sequence of enrollment can be found on the following pages of this MicroSort^® website.

There will be a limited number of sort openings available each month. Currently enrolled couples may continue to schedule sorts. New enrollment will seek to first accommodate couples who requested placement on the waiting list. Couples on the waiting list will be allowed access to MicroSort^® in the order in which they appear on the list but only after their eligibility to participate has been determined and they have correctly completed the enrollment process.

Sorting will be available as follows:

Fairfax, Virginia Site:

· Sorts for ICSI at GIVF
· Sorts for collaborators' patients

Laguna Hills, California Site:

· Sorts for IUI at HRC
· Sorts for ICSI at HRC
· Sorts for collaborators' patients

We will continue to provide updated clinical trial information on this web page or via eNews. 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.

The special pricing (PGD at the same price as MicroSort^®) that had been temporarily offered during the time while the FDA evaluated our continued access request will be honored for qualifying patients who have their initial PGD consult before June 30, 2008. The criteria for qualifying for this PGD offer remain unchanged. Please click here to learn more.

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.