Development of a Fetal Sex Assay From Maternal Whole Blood

Sequenom

Status: Completed

Conditions: Fetal Sex Determination

Study type: Observational

Funder types: Industry

Identifiers

NCT00970047

SQNM-FS-101

Details and patient eligibility

About

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

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 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.

Enrollment: 500 estimated patients

Sex: Female

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

Pregnant females

Description:

Women who are pregnant and between 6 and 16 weeks of gestation and who are 18 to 64 years of age.