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OpenTrials
Completed

NCT Number: NCT00970047

Development of a Fetal Sex Assay From Maternal Whole Blood

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

Completed

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Key information

Conditions

Fetal Sex Determination

Age range

18 year–64 year

Sex eligibility

Female

Study type

Observational

Primary location

IGO, San Diego, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Sequenom, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 2, 2009
Registry last updated
Feb 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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