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OpenTrials
Completed

NCT Number: NCT01021085

Evaluation of Fetal Sex 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.

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Key information

Conditions

Fetal Sex Determination

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

San Diego Fertility Center, 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 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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Develop a prenatal sex test using blood and/or urine samples from pregnant women.

    Time frame: 36 to 56 days of gestation

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sequenom, Inc.

Industry

Registry information

Official study title

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

Acronym: PREVIEW

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 26, 2009
Registry last updated
Sep 5, 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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