Clinical Use of Parental Support To Detect Single Gene Mutations
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|ClinicalTrials.gov Identifier: NCT01197872|
Recruitment Status : Completed
First Posted : September 9, 2010
Last Update Posted : July 16, 2013
|Condition or disease||Intervention/treatment|
|Single Gene Disorders||Other: Preimplantation Genetic Diagnosis|
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.
|Study Type :||Observational|
|Estimated Enrollment :||240 participants|
|Official Title:||Phase II: Clinical Use of Parental Support To Detect Single Gene Mutations|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
- Other: Preimplantation Genetic Diagnosis
Genetic testing on embryos to identify embryos that are affected by a single gene disorder (e.g. cystic fibrosis, Tay-Sachs, sickle cell anemia).Other Names:
- In Vitro Fertilization
- Parental Support
- Gene Security Network
- Confirmation of diagnosis through prenatal diagnosis [ Time Frame: 10-20 weeks post intervention ]Confirmation of PGS test results through prenatal diagnosis
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01197872
|United States, California|
|Gene Security Network|
|Redwood City, California, United States, 94063|
|Principal Investigator:||Matthew Rabinowitz, PhD||CEO, Gene Security Network|