hCG or Progesterone Effect on Unexplained Recurrent Pregnancy Loss
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Miscarriage
研究概览
简要总结
Up to half of all cases of recurrent pregnancy loss are unexplained (uRPL). Evidence points towards endometriosis and progesterone resistance as an underlying cause of uRPL. Previous non-RCT studies have suggested the luteal hCG provides a useful treatment for uRPL. We propose performing a randomized controlled trial to compare mid-luteal hCG with oral progesterone to prevent early pregnancy losses. the endpoint will be ongoing pregnancy and live birth rates. Equal numbers of patients will be randomized to each group.
详细描述
Fifty (50) patients with unexplained recurrent pregnancy loss, defined as 2 or more losses. Workup will exclude structural, genetic, hormonal, and anti-phospholipid syndrome-related causes of RPL. Women with unexplained RPL will be randomized to receive a mid-luteal injection of ovidril (250 ug) 1 week after ovulation vs prometrium (200 mg qhs) starting 4 days after ovulation. If pregnant, prometrium will be continued until 8 weeks of pregnancy. If pregnancy does not occur, subjects will be allowed to repeat this protocol for up to 3 cycles. Outcomes will be listed as "not pregnant", "biochemical pregnancy", "miscarriage" or "ongoing pregnancy" for each cycle. Endpoints of pregnant cycles will be compared for pregnancy rate, miscarriage rate, ongoing pregnancy rate and live birth rate.
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
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •2 first trimester losses
- •unexplained recurrent pregnancy loss
排除标准
- •Antiphospholipid syndrome
- •uterine septum
- •Asherman's syndrome
- •Paternal or maternal genetic abnormalities (i.e. balanced translocation)
- •Endocrine causes of RPL (thyroid, diabetes, hyperprolactinemia)
研究组 & 干预措施
Progesterone
Women receive prometrium 200 mg qhs for up to 8 weeks
干预措施: Progesterone Pill (Drug)
hCG
A single shot of hCG (ovidril 250 ug) will be given as a subcutaneous injection 1 week after ovulation
干预措施: hCG (Drug)
结局指标
主要结局
Miscarriage
时间窗: 4 to 11 weeks
Loss of pregnancy before 11 weeks of pregnancy
Ongoing pregnancy
时间窗: 8 weeks
Successgful pregnancy beyond 8 weeks of gestation with a heart beat
次要结局
- Live birth rate(40 weeks)