Development of a Fetal Sex Assay From Maternal Whole Blood

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00970047

Enrollment

500

Registered

2009-09-02

Start date

2008-06-30

Completion date

2010-07-31

Last updated

2011-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Sex Determination

Keywords

pregnant, fetal sex determination, gender determination, noninvasive test, fetal DNA

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 64 Years

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

Countries

United States

Outcome results