Evaluation of Fetal Sex in Assisted Reproductive Technology (ART) Achieved Pregnancies

Completed

• Conditions: Fetal Sex Determination

• Registration Number: NCT01021085
• Lead Sponsor: Sequenom, Inc.

Brief Summary

Whole blood and urine samples will be collected from pregnant woman of gestational age 36-56 days as confirmed by artificial reproductive technology (ART). The samples will be used to develop a prenatal sex test using circulating cell free fetal DNA (ccffDNA) in maternal plasma or urine.

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 and urine collection will occur between 36-42, 43-49, and 50-56 days gestation. The fetal gender will be requested at or soon after delivery. The accuracy of the test and the optimal time to perform the test during pregnancy will be assessed by comparing the test results from maternal blood and/or urine samples obtained between days 36 and 56 of gestation to the fetal sex results obtained at birth.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-10-29
• Study First Submitted QC: 2009-11-25
• Study First Posted: 2009-11-26
• Primary Completion: 2011-08
• Status Verified: 2011-09
• Study Completion: 2011-09
• Last Update Submitted: 2011-09-01
• Last Update Posted: 2011-09-05

Recruitment & Eligibility

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

Inclusion Criteria

• Subject is 18-45 years of age inclusive
• Subject is female
• Subject is pregnant
• Gestational age can be determined via IVF or IUI
• Subject is 36-42 days pregnant as determined by IVF transfer or IUI
• Subject agrees to provide 3 separate blood and urine samples

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Develop a prenatal sex test using blood and/or urine samples from pregnant women.	36 to 56 days of gestation

Secondary Outcome Measures

Name	Time	Method
Establish the earliest time point between days 36 and 56 of gestation that the prenatal sex test has optimal performance.	36 to 56 days of gestation

Trial Locations

Locations (3)

Fertility Center of Las Vegas; 🇺🇸 Las Vegas, Nevada, United States

Fertility Centers of Illinois; 🇺🇸 Glenview, Illinois, United States

San Diego Fertility Center; 🇺🇸 San Diego, California, United States