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

This study has been completed.
Information provided by (Responsible Party):
Natera, Inc. Identifier:
First received: February 24, 2012
Last updated: August 8, 2013
Last verified: August 2013

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 Intervention
Pregnancy Following IVF With PGS/PGD
Procedure: Blood draw

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Prenatal Diagnosis of Fetal DNA Isolated From Maternal Plasma

Resource links provided by NLM:

Further study details as provided by Natera, Inc.:

Primary Outcome Measures:
  • 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


Enrollment: 16
Study Start Date: February 2012
Study Completion Date: August 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.


Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Please refer to this study by its identifier: 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
  More Information

No publications provided

Responsible Party: Natera, Inc. Identifier: NCT01546324     History of Changes
Other Study ID Numbers: IVF013
Study First Received: February 24, 2012
Last Updated: August 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Natera, Inc.:
Maternal Blood
Gene Security Network
Non-invasive prenatal diagnosis processed this record on April 15, 2014