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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-09-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Fetal Sex Determination

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Pregnant women

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

No interventions assigned to this group

Eligibility Criteria

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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