Development of a Fetal Sex Assay From Maternal Whole Blood

Sequenom, Inc.500 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Fetal Sex Determination

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Locations (3)

NCOG Medical Group

San Diego, California, United States

IGO

San Diego, California, United States

Scripps Clinic Medial Group

San Diego, California, United States

Data from ClinicalTrials.gov

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