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

Pregnancy Following IVF With PGS/PGD Clinical Trial

Official title:

Prenatal Diagnosis of Fetal DNA Isolated From Maternal Plasma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01546324
• Other study ID #: IVF013
• Status: Completed
• Phase: N/A
• First received: February 24, 2012
• Last updated: August 8, 2013
• Start date: February 2012
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: Natera, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Pregnancy Following IVF With PGS/PGD

Intervention

Procedure:
• Blood draw
Maternal blood draw at approximately 8-17 weeks gestation.

Locations

Country	Name	City	State
United States	Natera, Inc	Redwood City	California

Sponsors (1)

Lead Sponsor	Collaborator
Natera, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection of 500 maternal blood samples to be used for development of non-invasive prenatal diagnostic testing.		1 year	No