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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Natera, Inc.
ClinicalTrials.gov Identifier:
NCT01546324
First received: February 24, 2012
Last updated: August 8, 2013
Last verified: August 2013
  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:


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


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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Natera, Inc
Redwood City, California, United States, 94063
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: August 8, 2013
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 August 28, 2014