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

This study is currently recruiting participants.
Verified February 2012 by Natera, Inc.
Sponsor:
Information provided by (Responsible Party):
Natera, Inc.
ClinicalTrials.gov Identifier:
NCT01546324
First received: February 24, 2012
Last updated: March 1, 2012
Last verified: February 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

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

Blood


Estimated Enrollment: 500
Study Start Date: February 2012
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.

  Eligibility

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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01546324

Contacts
Contact: Nina Wemmer, MS, CGC 650-249-9090 ext 342 info@natera.com

Locations
United States, California
Natera, Inc Recruiting
Redwood City, California, United States, 94063
Contact: Nina Wemmer, MS, CGC     650-249-9090 ext 342     info@natera.com    
Principal Investigator: Matthew Rabinowitz, PhD            
Sponsors and Collaborators
Natera, Inc.
Investigators
Principal Investigator: Matthew Rabinowitz, PhD CEO, Natera, Inc
  More Information

No publications provided

Responsible Party: Natera, Inc.
ClinicalTrials.gov Identifier: NCT01546324     History of Changes
Other Study ID Numbers: IVF013
Study First Received: February 24, 2012
Last Updated: March 1, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 22, 2013