Fetal Aneuploidies Screening (21,18 and 13) by Cell Free Fetal DNA Analysis. Pilot Study in Low Risk Population and Pregnant Women After in Vitro Fertilisation (IFV)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 933
- 试验地点
- 2
- 主要终点
- Diagnostic performance measured by specificity (%) of genetic Non Invasive Prenatal Testing (NIPT) in the two populations (with and without IVF) compared to regular serum screening
研究概览
简要总结
The purpose of this study is to evaluate the performance of non invasive screening in a population of pregnant women with and without in vitro fertilisation (IVF) concomitantly to regular first trimester trisomy 21 (T21) screening using maternal age, nucal fold measurement and serum screening.
详细描述
All pregnant women in 9 institutions in France will be offer both regular first trimester screening for trisomy 21 (T21) and cell free DNA non invasive (NI) screening test at the same time. Specificity and the positive and negative predictive values of the NI test will be analysed. The population will be divided in women who did and did not get pregnant after an In vitro fertilisation (IVF) procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnancy
- •Having a spontaneous pregnancy or obtained by AMP ,
- •Having chosen to carry out a screening of the T21 to the first or second trimester of pregnancy ,
- •Gestational age >=10 weeks of amenorrhea
- •Consenting to invasive prenatal diagnosis,
- •Having health insurance,
- •Having signed the informed consent
排除标准
- •The Patients whose fetus has an abnormality on the first trimester ultrasound including nuchal translucency > 3.5mm ,
- •Participant to another biomedical research.
- •Pregnancy twins including the presence of a twin vanishing
研究组 & 干预措施
Genetic NIPT and regular serum screening
All woman will be tested using the two tests, genetic NIPT (Non Invasive Prenatal Testing) and regular serum screening.
干预措施: Genetic NIPT (Device)
Genetic NIPT and regular serum screening
All woman will be tested using the two tests, genetic NIPT (Non Invasive Prenatal Testing) and regular serum screening.
干预措施: Regular serum screening (Biological)
结局指标
主要结局
Diagnostic performance measured by specificity (%) of genetic Non Invasive Prenatal Testing (NIPT) in the two populations (with and without IVF) compared to regular serum screening
时间窗: Between the 11th and the 13th week of amenorrhea
次要结局
- Diagnostic performance measured by positive predictive values (%) of genetic NIPT (Non Invasive Prenatal Testing) in the two populations compared to regular serum screening(Between the 11th and the 13th week of amenorrhea)
- Diagnostic performance measured by negative predictive values (%) of genetic NIPT (Non Invasive Prenatal Testing) in the two populations compared to regular serum screening(Between the 11th and the 13th week of amenorrhea)