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

NCT ID: NCT01546324

Last Updated: 2013-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pregnancy Following IVF With PGS/PGD

Keywords

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Maternal Blood PGD PGS Natera Gene Security Network Non-invasive prenatal diagnosis

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Pregnant women

Women pregnant following the use of Natera's PGS/PGD testing

Blood draw

Intervention Type PROCEDURE

Maternal blood draw at approximately 8-17 weeks gestation.

Interventions

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Blood draw

Maternal blood draw at approximately 8-17 weeks gestation.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Natera, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew Rabinowitz, PhD

Role: PRINCIPAL_INVESTIGATOR

CEO, Natera, Inc

Locations

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Natera, Inc

Redwood City, California, United States

Site Status

Countries

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United States

Other Identifiers

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IVF013

Identifier Type: -

Identifier Source: org_study_id