Development of a Fetal Sex Assay From Maternal Whole Blood

Completed

• Conditions: Fetal Sex Determination

• Registration Number: NCT00970047
• Lead Sponsor: Sequenom, Inc.

Brief Summary

Whole blood from pregnant women will be collected to develop a noninvasive fetal sex test.

Detailed Description

This is an observational study whereby samples will be tested to determine the presence or absence of fetal Y chromosome genes to test for the fetal sex of the baby. The blood draw will occur between 6 to 16 weeks of gestation. The fetal gender will be requested at or soon after delivery if fetal sex was not previously obtained by CVS or amniocentesis genetic analysis.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-08-31
• Study First Submitted QC: 2009-09-01
• Study First Posted: 2009-09-02
• Status Verified: 2009-10
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Last Update Submitted: 2011-01-31
• Last Update Posted: 2011-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

• Subject is 18-64 years of age
• Subject is female
• Subject is pregnant and between 6 and 16 weeks of gestation
• Subject provides a signed and dated informed consent
• If subject undergoes a routine ultrasound between weeks 16 and 28, she agrees to provide the fetal sex results
• If subject undergoes an invasive procedure, she agrees to provide the fetal sex results

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (3)

NCOG Medical Group; 🇺🇸 San Diego, California, United States

IGO; 🇺🇸 San Diego, California, United States

Scripps Clinic Medial Group; 🇺🇸 San Diego, California, United States