Single Gene Disorders Clinical Trial
Official title:
Phase II: Clinical Use of Parental Support To Detect Single Gene Mutations
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 technology allows IVF physicians to identify embryos, prior to transfer to the uterus, which have the best chance of developing into healthy children.
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.
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Time Perspective: Prospective