A Randomized, Controlled Trial of Cyclosporin A for Women With Unexplained Recurrent Miscarriage
试验速览
- 阶段
- 2 期
- 入组人数
- 384
- 试验地点
- 1
- 主要终点
- Live birth rate
研究概览
简要总结
The purpose of this study is to determine whether Cyclosporin A (CsA) - an immunosuppressant drug - in early pregnancy will reduce the risk of miscarriage in women who had a history of unexplained recurrent miscarriages, as compared with that treated with Dydrogesterone-an active comparator. The hypothesis is based on the evidence found in vitro and in vivo experiments that CsA can induce maternal-fetal tolerance so that it may reduce the risk of miscarriage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Both the woman and her husband agree to participate and sign the informed consent form.
- •Have a history of two or more unexplained recurrent miscarriages.
- •Spontaneous conception.
- •Gestational age less than 5 weeks.
- •Have a normal menstrual cycle (>=23 and <=35 days) and biphasic pattern of basal body temperature before pregnancy.
- •No significant chromosomal aberrations in the couple.
- •Semen quality tests show not apparent abnormalities in husband
排除标准
- •Age below 18 or above 41 years at conception.
- •Present pregnancy is a result of donor insemination or egg donation.
- •Significant uterine anomalies detected by ultrasonography, hysterosalpingography, or hysteroscopy.
- •Contraindications of CsA (e.g. severe infectious diseases, tumor or immunodeficiency) or Dydrogesterone.
- •Smoking more than 20 daily.
研究组 & 干预措施
Cyclosporin A
Patients allocated to Cyclosporin A group will receive oral Cyclosporin A in a dose of 50 mg three times a day for 20-30 days in early pregnancy.
干预措施: Cyclosporin A (Drug)
Dydrogesterone
Patients allocated to dydrogesterone group will receive oral dydrogesterone in a dose of 10 mg three times a day for 30 days in early pregnancy.
干预措施: Dydrogesterone (Drug)
结局指标
主要结局
Live birth rate
时间窗: Up to 36 months
The difference in the live birth rates between patients with recurrent miscarriage assigned oral CsA and Dydrogesterone.
次要结局
- The difference in the rate of miscarriage between patients with recurrent miscarriage treated with CsA and Dydrogesterone.(Up to 36 months)
- Fetal death(Up to 36 months)
- The difference in the rate of premature delivery between patients treated with CsA and Dydrogesterone.(Up to 36 months)
- Congenital malformations(Up to 36 months)
- Maternal outcomes: morbidity of infectious disease(Up to 36 months)