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

Prenatal Diagnosis of Fetal DNA Isolated From Maternal Plasma

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01546324

Enrollment

Registered

2012-03-07

Start date

2012-02-29

Completion date

2013-08-31

Last updated

2013-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Following IVF With PGS/PGD

Keywords

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

Brief 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.

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.

Interventions

PROCEDUREBlood draw

Maternal blood draw at approximately 8-17 weeks gestation.

Study design

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026