Evaluation Of A Fetal Sex Determination Test At 36-56 Days Gestation In Assisted Reproductive Technology (ART) Achieved Pregnancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Develop a prenatal sex test using blood and/or urine samples from pregnant women.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Develop a prenatal sex test using blood and/or urine samples from pregnant women.
时间窗: 36 to 56 days of gestation
次要结局
- 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)