Skip to main content
OpenTrials
Completed

NCT Number: NCT01546324

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Natera, Inc

Redwood City, California, 94063, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood draw

Procedure

Maternal blood draw at approximately 8-17 weeks gestation.

Primary outcomes

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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Natera, Inc.

Industry

Registry information

Official study title

Prenatal Diagnosis of Fetal DNA Isolated From Maternal Plasma

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Mar 7, 2012
Registry last updated
Aug 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.