Collection of Maternal Blood Samples for Development of Non-invasive Prenatal Diagnostic Testing
The purpose of this study is to collect blood samples from pregnant women who achieved pregnancy following in-vitro fertilization (IVF) with Natera's preimplantation aneuploidy screening (with or without single gene gene testing). These samples will be used for test development of non-invasive prenatal diagnostic testing.
|Study Design:||Time Perspective: Cross-Sectional|
|Official Title:||Prenatal Diagnosis of Fetal DNA Isolated From Maternal Plasma|
- Collection of 500 maternal blood samples to be used for development of non-invasive prenatal diagnostic testing. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||February 2012|
|Study Completion Date:||August 2013|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Women pregnant following the use of Natera's PGS/PGD testing
Procedure: Blood draw
Maternal blood draw at approximately 8-17 weeks gestation.
Eligible subjects will sign a consent form and have blood drawn at approximately 8-17 weeks gestation. Subjects will received $200 reimbursement for providing this blood sample. The collected samples will be used to help develop non-invasive prenatal diagnostic testing using Natera's Parental Support technology which is already commercialized for genetic diagnosis of in-vitro embryos. In this study, the technology will be tested for it's ability to analyze fetal-specific pieces of DNA isolated from the mother's blood. No results of the maternal blood testing will be reported to the subject or to their physicians.