PLEASE TAKE NOTE:

MicroSort® IUI is now available at the Fairfax, VA site

Genetics & IVF Institute is pleased to announce the MicroSort® clinical trial is now resuming IUI availability at the Fairfax, VA site, effective January 1, 2009. There will be a limited number of MicroSort® IUIs available for participants in the MicroSort® clinical trial each month. If you have previously been enrolled and are interested in a MicroSort® IUI, email microsort@givf.com with your name, date of birth and contact information so that we may get back to you. If you are not yet enrolled and would like to determine eligibility for the clinical trial, click here. All inquiries must be done via email. After December 17, 2008, we will make a further announcement regarding scheduling IUIs.

First priority will be given to couples attempting to prevent Genetic Disease by using MicroSort® sorted sperm, followed by women turning 40 in the next 6 months, and couples previously enrolled in the clinical trial. All other requests will be handled on a first come, first served basis.

Please note: Phone calls/emails: All emails will be returned in the order of priority (described above) and order of receipt. All submitted history and registration forms will be reviewed in the order of priority (described above) and order of receipt. We will make every effort to contact you in a timely manner during weekday business hours only. MicroSort® is a clinical trial: Remember that MicroSort® is a clinical trial under FDA oversight. Specific rules must be followed. There can be no special allowances with regards to following the rules.

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 IUIs at GIVF on a limited basis
· 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 opportunity to participate in a clinical trial that could increase the chance of having a child of a desired gender - boy or girl. This clinical trial uses sperm-sorting technology that may be indicated either 1) to reduce the probability of inheriting X-linked diseases or 2) to achieve family balancing. MicroSort® sorting technology utilizes flow cytometric separation technology with the goal of enriching the fraction of sorted sperm that carry either the X (female) or the Y (male) chromosome. The clinical trial results support the basic concept that the chance of having a child with the desired sex is correspondingly increased as the proportion of either X- or Y-bearing sperm is increased.

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.

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.

MicroSort staff will be happy to explain details regarding what will be required for couples who wish to participate in the clinical trial.

* Data from the clinical trial indicate that individual samples from a specific sort will vary above and below this average. The percentage of X- and Y-bearing sperm cells present in each sample is determined after the sort, usually within one week.

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.