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

Sequenom

Status: Completed

Conditions: Fetal Sex Determination

Study type: Observational

Funder types: Industry

Identifiers

NCT01021085

SQNM-IVF-FS-102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

Pregnant women

Description:

Pregnant women who have conceived via ART and are between days 36 and 56 of gestation