Fetal Sex Determination
Conditions
Keywords
Assisted Reproductive Technology, circulating cell free fetal DNA, First trimester
Brief summary
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.
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.
Interventions
None listed
Sponsors
Sequenom, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Develop a prenatal sex test using blood and/or urine samples from pregnant women. | 36 to 56 days of gestation |
Secondary
| Measure | Time frame |
|---|---|
| Establish the earliest time point between days 36 and 56 of gestation that the prenatal sex test has optimal performance. | 36 to 56 days of gestation |
Countries
United States
Outcome results
None listed