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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01546324
Recruitment Status : Completed
First Posted : March 7, 2012
Last Update Posted : August 12, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Pregnancy Following IVF With PGS/PGD Procedure: Blood draw

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 Type : Observational
Actual Enrollment : 16 participants
Time Perspective: Cross-Sectional
Official Title: Prenatal Diagnosis of Fetal DNA Isolated From Maternal Plasma
Study Start Date : February 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : August 2013

Group/Cohort Intervention/treatment
Pregnant women
Women pregnant following the use of Natera's PGS/PGD testing
Procedure: Blood draw
Maternal blood draw at approximately 8-17 weeks gestation.

Primary Outcome Measures :
  1. Collection of 500 maternal blood samples to be used for development of non-invasive prenatal diagnostic testing. [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women 18 years of age or older who used Natera (formerly Gene Security Network)'s Preimplantation Genetic testing (PGS/PGD) to achieve their current pregnancy.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01546324

United States, California
Natera, Inc
Redwood City, California, United States, 94063
Sponsors and Collaborators
Natera, Inc.
Principal Investigator: Matthew Rabinowitz, PhD CEO, Natera, Inc

Responsible Party: Natera, Inc. Identifier: NCT01546324     History of Changes
Other Study ID Numbers: IVF013
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: August 2013

Keywords provided by Natera, Inc.:
Maternal Blood
Gene Security Network
Non-invasive prenatal diagnosis