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Evaluation of Fetal Sex in Assisted Reproductive Technology (ART) Achieved Pregnancies (PREVIEW)

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ClinicalTrials.gov Identifier: NCT01021085
Recruitment Status : Completed
First Posted : November 26, 2009
Last Update Posted : September 5, 2011
Sponsor:
Information provided by (Responsible Party):
Sequenom, Inc.

Brief Summary:
Whole blood and urine samples will be collected from pregnant woman of gestational age 36-56 days as confirmed by artificial reproductive technology (ART). The samples will be used to develop a prenatal sex test using circulating cell free fetal DNA (ccffDNA) in maternal plasma or urine.

Condition or disease
Fetal Sex Determination

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 and urine collection will occur between 36-42, 43-49, and 50-56 days gestation. The fetal gender will be requested at or soon after delivery. The accuracy of the test and the optimal time to perform the test during pregnancy will be assessed by comparing the test results from maternal blood and/or urine samples obtained between days 36 and 56 of gestation to the fetal sex results obtained at birth.

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Evaluation Of A Fetal Sex Determination Test At 36-56 Days Gestation In Assisted Reproductive Technology (ART) Achieved Pregnancies
Study Start Date : April 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : September 2011

Group/Cohort
Pregnant women
Pregnant women who have conceived via ART and are between days 36 and 56 of gestation



Primary Outcome Measures :
  1. Develop a prenatal sex test using blood and/or urine samples from pregnant women. [ Time Frame: 36 to 56 days of gestation ]

Secondary Outcome Measures :
  1. Establish the earliest time point between days 36 and 56 of gestation that the prenatal sex test has optimal performance. [ Time Frame: 36 to 56 days of gestation ]

Biospecimen Retention:   Samples With DNA
Maternal whole blood and urine will be collected. Whole blood will be processed to plasma and buffy coat.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women who are pregnant via assisted reproductive technology between days 36 and 56 gestational age
Criteria

Inclusion Criteria:

  • Subject is 18-45 years of age inclusive
  • Subject is female
  • Subject is pregnant
  • Gestational age can be determined via IVF or IUI
  • Subject is 36-42 days pregnant as determined by IVF transfer or IUI
  • Subject agrees to provide 3 separate blood and urine samples

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01021085


Locations
United States, California
San Diego Fertility Center
San Diego, California, United States, 92130
United States, Illinois
Fertility Centers of Illinois
Glenview, Illinois, United States, 60026
United States, Nevada
Fertility Center of Las Vegas
Las Vegas, Nevada, United States, 89117
Sponsors and Collaborators
Sequenom, Inc.
Investigators
Study Director: Allan Bombard, MD MBA Sequenom, Inc.

Responsible Party: Sequenom, Inc.
ClinicalTrials.gov Identifier: NCT01021085     History of Changes
Other Study ID Numbers: SQNM-IVF-FS-102
First Posted: November 26, 2009    Key Record Dates
Last Update Posted: September 5, 2011
Last Verified: September 2011

Keywords provided by Sequenom, Inc.:
Assisted Reproductive Technology
circulating cell free fetal DNA
First trimester