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

September 1, 2011 updated by: Sequenom, Inc.

Evaluation Of A Fetal Sex Determination Test At 36-56 Days Gestation In Assisted Reproductive Technology (ART) Achieved Pregnancies

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92130
        • San Diego Fertility Center
    • Illinois
      • Glenview, Illinois, United States, 60026
        • Fertility Centers of Illinois
    • Nevada
      • Las Vegas, Nevada, United States, 89117
        • Fertility center of Las Vegas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women who are pregnant via assisted reproductive technology between days 36 and 56 gestational age

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
36 to 56 days of gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sequenom, Inc.

Investigators

  • Study Director: Allan Bombard, MD MBA, Sequenom, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

October 29, 2009

First Submitted That Met QC Criteria

November 25, 2009

First Posted (Estimate)

November 26, 2009

Study Record Updates

Last Update Posted (Estimate)

September 5, 2011

Last Update Submitted That Met QC Criteria

September 1, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SQNM-IVF-FS-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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