Prenatal Diagnosis of Fetal DNA Isolated From Maternal Plasma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pregnancy Following IVF With PGS/PGD
- Sponsor
- Natera, Inc.
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Collection of 500 maternal blood samples to be used for development of non-invasive prenatal diagnostic testing.
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pregnant women willing to donate a blood sample during the first or second trimester of their pregnancy (approximately 8-17 weeks gestation)
- •Use of Natera (formerly Gene Security Network)'s commercial preimplantation genetic testing (PGS/PGD)to achieve the current pregnancy
Exclusion Criteria
- •Pregnant women who did not use Natera (formerly Gene Security Network)'s PGS/PGD testing to achieve their current pregnancy
Outcomes
Primary Outcomes
Collection of 500 maternal blood samples to be used for development of non-invasive prenatal diagnostic testing.
Time Frame: 1 year