Development of a Noninvasive Fetal Sex Determination Test Between 6 and 16 Weeks of Gestation

Sequenom, Inc.3 sites in 1 country500 target enrollmentJune 2008

ConditionsFetal Sex Determination

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Fetal Sex Determination
Sponsor: Sequenom, Inc.
Enrollment: 500
Locations: 3
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2008

End Date

July 2010

Last Updated

15 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Sequenom, Inc.

Eligibility Criteria

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