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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sequenom, Inc.
ClinicalTrials.gov Identifier:
NCT01021085
First received: October 29, 2009
Last updated: September 1, 2011
Last verified: September 2011
  Purpose

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
Fetal Sex Determination

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sequenom, Inc.:

Primary Outcome Measures:
  • Develop a prenatal sex test using blood and/or urine samples from pregnant women. [ Time Frame: 36 to 56 days of gestation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Maternal whole blood and urine will be collected. Whole blood will be processed to plasma and buffy coat.


Estimated Enrollment: 500
Study Start Date: April 2009
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pregnant women
Pregnant women who have conceived via ART and are between days 36 and 56 of gestation

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

Responsible Party: Sequenom, Inc.
ClinicalTrials.gov Identifier: NCT01021085     History of Changes
Other Study ID Numbers: SQNM-IVF-FS-102
Study First Received: October 29, 2009
Last Updated: September 1, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 22, 2014