Collection of Maternal Blood Samples for Development of Non-invasive Prenatal Diagnostic Testing

Completed

• Conditions: Pregnancy Following IVF With PGS/PGD
• Interventions: Procedure: Blood draw

• Registration Number: NCT01546324
• Lead Sponsor: Natera, Inc.

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-24
• Study First Submitted QC: 2012-03-01
• Study First Posted: 2012-03-07
• Primary Completion: 2012-05
• Status Verified: 2013-08
• Study Completion: 2013-08
• Last Update Submitted: 2013-08-08
• Last Update Posted: 2013-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant women	Blood draw	Women pregnant following the use of Natera's PGS/PGD testing

Primary Outcome Measures

Name	Time	Method
Collection of 500 maternal blood samples to be used for development of non-invasive prenatal diagnostic testing.	1 year

Trial Locations

Locations (1)

Natera, Inc; 🇺🇸 Redwood City, California, United States