MicroSort®
MicroSort® is an exclusive preconception sperm sorting technology, developed by the Genetics & IVF Institute (GIVF), and designed to increase the likelihood of conceiving a child of a particular gender. Genetics and IVF Institute is conducting a clinical trial using the MicroSort® technology. This research study uses MicroSort®’s patented technology, which is designed for the purpose of separating sperm either into those that primarily produce girls or those that primarily produce boys. Sorted specimens enriched in male- or female-producing sperm are then used for intrauterine insemination (IUI) or for in-vitro fertilization (IVF). In compliance with the FDA clinical trial, MicroSort® is available only to patients who meet the requirements for clinical trial participation. Study data so far indicate that for patients sorting sperm for a girl baby, approximately 9 out of 10* of those who became pregnant were successful in conceiving a female baby; for those sorting for a boy baby, approximately 3 out of 4* who became pregnant were successful in conceiving a male baby.  

The Genetics & IVF Institute (GIVF) is offering couples the opportunity to participate in this unique clinical trial using the MicroSort® sperm-sorting technology to increase the likelihood of having a child of a particular gender either 1) to reduce the probability of inheriting X-linked genetics diseases or 2) to achieve family balancing.

Participation in the clinical trial is limited to married couples with a documented history of gender-linked disease or to those who meet the criteria for MicroSort®’s family balancing indication.

Sperm that have been sorted using the MicroSort® technology can be used with assisted reproductive technologies at either of the sites affiliated with the MicroSort® - the world-class GIVF clinical facility in Fairfax, VA or Huntington Reproductive Center (HRC), one of the largest infertility clinics in the Western United States. Intrauterine insemination (IUI) or IVF/ ICSI can be performed at either site with freshly sorted (non-frozen) sperm. Alternatively, your semen sample may be sorted in one of the MicroSort laboratories, and then frozen and shipped to a collaborating physician for use in an IVF or IVF/ICSI procedure. IUI procedures with frozen MicroSort-sorted sperm are not recommended.

Enrollment in MicroSort®
MicroSort® staff are ready to assist couples who are considering participation in the MicroSort® clinical trial.

If you are already enrolled and are considering a MicroSort® IUI, or MicroSort® IVF/ICSI, email microsort@givf.com with your name, date of birth and contact information.  If you are not yet enrolled and would like to determine eligibility for the clinical trial, click here.  Please submit inquiries by email.

First priority will be given to couples attempting to prevent sex linked or sex limited disease by using MicroSort® sorted sperm, all other requests will be handled on a first come, first served basis..

MICROSORT® CLINICAL TRIAL UPDATE

• MicroSort® PMA Submitted for FDA Review

• Continued Access Granted During PMA Review

• MicroSort® Enrollment/Eligibility Requirements Unchanged

• IUI and IVF/ICSI Available at Both MicroSort® Sites

MicroSort® PMA Submitted for FDA Review
Genetics & IVF Institute is pleased to announce that the MicroSort Premarket Approval (PMA) application has been submitted to FDA for review. The PMA review is anticipated to occur over the remainder of the year. Please check this page for periodic updates.

Continued Access Granted during PMA Review
GIVF has been granted permission by the FDA to continue, on a limited basis, enrollment of new participants in the MicroSort® clinical trial. Continued access does not represent FDA approval of MicroSort®, but does allow us to continue to offer MicroSort® under the clinical trial while the PMA is being reviewed by FDA.

MicroSort® Enrollment/Eligibility Requirements Unchanged
The clinical trial's eligibility requirements and enrollment procedures to access MicroSort® apply to continued access patients. Clinical trial forms, procedures, and enrollment steps can be found on the following pages of this MicroSort® website.
Currently enrolled couples may continue to schedule sorts.  New couples must have their eligibility to participate determined and must have correctly completed the enrollment process prior to sorting.

IUI and IVF/ICSI Available at Both MicroSort® Sites
MicroSort® clinical trial participants have IUI and IVF/ICSI available at the MicroSort® sites in Fairfax, VA and Laguna Hills CA.

Fairfax, Virginia Site                                              Laguna Hills, California Site
· Sorts for IUI at GIVF                                              · Sorts for IUI at HRC
· Sorts for ICSI at GIVF                                            · Sorts for ICSI at HRC
· Sorts for collaborators' patients                               · 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.

* Clinical trial data indicate that results from individual sorts will vary above and below this average (88% for X-Sort and 74% for Y-Sort). The percentage of X- and Y bearing sperm in the sorted specimen will vary from sort to sort and should affect the likelihood that a male or female is conceived. The approximate percentage of X- and Y-bearing sperm cells present in each sample is determined after the sort, usually within one or two weeks. Please see the Current Results page for our most recent data.

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.

CAUTION - Investigational Device. Limited by Federal (or United States) law to investigational use.