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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01546324
|United States, California|
|Redwood City, California, United States, 94063|
|Principal Investigator:||Matthew Rabinowitz, PhD||CEO, Natera, Inc|