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.
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
500
San Diego Fertility Center
San Diego, California, United States
Fertility Centers of Illinois
Glenview, Illinois, United States
Fertility Center of Las Vegas
Las Vegas, Nevada, United States
Develop a prenatal sex test using blood and/or urine samples from pregnant women.
Time frame: 36 to 56 days of gestation
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
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