Development of a Fetal Sex Assay From Maternal Whole Blood

This study has been completed.
Sponsor:
Information provided by:
Sequenom, Inc.
ClinicalTrials.gov Identifier:
NCT00970047
First received: August 31, 2009
Last updated: January 31, 2011
Last verified: October 2009
  Purpose

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


Condition
Fetal Sex Determination

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Development of a Noninvasive Fetal Sex Determination Test Between 6 and 16 Weeks of Gestation

Further study details as provided by Sequenom, Inc.:

Biospecimen Retention:   Samples With DNA

Plasma and PBMCs


Estimated Enrollment: 500
Study Start Date: June 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pregnant females
Women who are pregnant and between 6 and 16 weeks of gestation and who are 18 to 64 years of age.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pregnant women between 6 and 16 weeks of gestation.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00970047

Locations
United States, California
IGO
San Diego, California, United States, 92121
NCOG Medical Group
San Diego, California, United States, 92037
Scripps Clinic Medial Group
San Diego, California, United States, 92128
Sponsors and Collaborators
Sequenom, Inc.
Investigators
Study Director: Allan Bombard, MD, MBA Sequenom, Inc.
  More Information

No publications provided

Responsible Party: Allan Bombard / Chief Medical Officer, Sequenom, Inc.
ClinicalTrials.gov Identifier: NCT00970047     History of Changes
Other Study ID Numbers: SQNM-FS-101
Study First Received: August 31, 2009
Last Updated: January 31, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Sequenom, Inc.:
pregnant
fetal sex determination
gender determination
noninvasive test
fetal DNA

ClinicalTrials.gov processed this record on September 18, 2014