Clinical Use of Parental Support To Detect Single Gene Mutations
|Study Design:||Time Perspective: Prospective|
|Official Title:||Phase II: Clinical Use of Parental Support To Detect Single Gene Mutations|
- Confirmation of diagnosis through prenatal diagnosis [ Time Frame: 10-20 weeks post intervention ] [ Designated as safety issue: No ]Confirmation of PGS test results through prenatal diagnosis
Biospecimen Retention: Samples With DNA
|Study Start Date:||September 2010|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Other: Preimplantation Genetic Diagnosis
- In Vitro Fertilization
- Parental Support
- Gene Security Network
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 clinical use of PS to detect specific genetic mutation(s) known to cause severe inheritable diseases in embryos produced by at-risk couples, while simultaneously testing these embryos for aneuploidy. The Phase I study consisted of first of its kind PGS/D testing to detect disease-associated genetic mutations together with aneuploidy screening.
This study, which we will call "Phase II", will allow patients to continue to access testing while clinical data is collected on Phase I. Phase I of the study is nearing enrollment targets (40+ participating couples) and Phase I enrollment will be closed while subjects complete testing and study data is collected from pregnancies and livebirths. Phase II will allow: 1) additional data collection prior to commercial testing launch, 2) eligible patients to participate and receive testing.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197872
|United States, California|
|Gene Security Network|
|Redwood City, California, United States, 94063|
|Principal Investigator:||Matthew Rabinowitz, PhD||CEO, Gene Security Network|