Status:
COMPLETED
Clinical Use of Parental Support To Detect Single Gene Mutations
Lead Sponsor:
Natera, Inc.
Conditions:
Single Gene Disorders
Eligibility:
All Genders
Brief Summary
Gene Security Network has developed a novel technology called Parental Support (PS) which is used for Preimplantation Genetic Screening/Diagnosis (PGS/D) during in vitro fertilization (IVF). This tech...
Detailed Description
This study follows previous IRB approved study IVF008: Clinical Use of Parental Support To Detect Single Gene Mutations , which we will refer to as "Phase I". The purpose of Phase I was to validate c...
Eligibility Criteria
Inclusion
- At risk couple (mother and father) who are:
- Able to provide laboratory report from commercial CLIA certified laboratory in the United States or legitimate non-US laboratory confirming presence of disease associated mutation in mother and/or father
- Planning to go through IVF and desiring PGD for the specified mutation
- Planning to pursue Chorionic Villus Sampling (CVS) or Amniocentesis if pregnancy occurs and willing/able to provide CVS/ Amniocentesis sample to GSN for confirmatory testing or provide test results of confirmatory testing performed by an external laboratory.
Exclusion
- Couples without prior documentation of genetic mutation as specified above
- Couples where the male partner is not willing, able, or available to provide a semen sample
- Unwilling to have CVS/ Amniocentesis
- In certain cases, unavailability of child sample or other suitable family member: Subjects will not be able to enroll in the study if, in the judgment of the research staff, validation is first required on a child (offspring of male and female subject) and there is no child or other family member that is a suitable substitute available for testing.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2013
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT01197872
Start Date
September 1 2010
End Date
June 1 2013
Last Update
July 16 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Gene Security Network
Redwood City, California, United States, 94063