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

Prenatal Diagnosis of Fetal DNA Isolated From Maternal Plasma

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Following IVF With PGS/PGD
• Intervention / Treatment: 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
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Natera, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Collection of 500 maternal blood samples to be used for development of non-invasive prenatal diagnostic testing.	1 year

Collaborators and Investigators

• Sponsor: Natera, Inc.
• Investigators: Principal Investigator: Matthew Rabinowitz, PhD, CEO, Natera, Inc

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: February 24, 2012
• First Submitted That Met QC Criteria: March 1, 2012
• First Posted (Estimate): March 7, 2012

Study Record Updates

• Last Update Posted (Estimate): August 12, 2013
• Last Update Submitted That Met QC Criteria: August 8, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: PGD; PGS; Natera; Maternal Blood; Gene Security Network; Non-invasive prenatal diagnosis
• Other Study ID Numbers: IVF013