先兆子痫率的自然周期或刺激周期与激素替代周期
冻融胚胎移植患者自然周期或刺激周期与激素替代周期的活产率
研究概览
地位
条件
详细说明
Recent sutdies indicate that the existence of corpus lutein in the ovary is a key point to prevent preeclampsia, and patients undergoing FET with hormone replaced cycle have no corpus lutein and the absence of corpus lutein significantly increases the risk of preeclampsia in these patients. We aim to conduct a single center randomized controlled non-inferiority trial to compare the live birth rate and gestational hypertention disease rate between the natural cycle and the hormone replaced cycle in women undergoing FET.
The investigators plan to enroll women scheduled for frozen-thawed cycles. Eligible participants will be randomised 1:1 to the natural cycle and the hormone replaced cycle for endometrium preparation. All other IVF procedures will be carried out following a routine method in each center. Women will be followed up until six months after randomisation for those who fail to get pregnant after the completion of the first embryo transfer or delivery for those who get pregnant after the embryo transfer. The primary outcome is live birth after the embryo transfer. Primary analysis will be by intention-to-treat analysis. A 10% live birth is considered to be valid. Considering 10% loss to follow-up with a significance level at 0.05 and a power of 80%, the investigators plan to recruit 960 women to demonstrate women treated with natural cycle have no inferiority regarding live birth rate than those treated with hormone replacement cycle.
研究类型
阶段
- 不适用
联系人和位置
参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准:
- 18至42岁的女性;
- 正常排卵;
- 计划进行冻融胚胎移植。
- 同意知情同意。
排除标准:
- 胚胎移植周期至少3次失败者;
- 切除了一个或两个卵巢;
- 胚胎移植前的高血压病;
- 没有可供移植的胚胎
- 卵母细胞或精子捐赠周期
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:natural cycle for endometrium preparation
patients will not receive oral contraceptive drugs for menstruation or drugs for ovulation induction before embryo transfer and patients will ovulate before embryo transfer
|
patients will not use oral contraceptive drugs
其他名称:
|
|
有源比较器:hormone replaced cycle for endometrium preparation
patients will receive oral contraceptive drugs for menstruation before embryo transfer and patients will not ovulate before embryo transfer
|
patients will receive oral contraceptive drugs for menstruation before embryo transfer
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The Gestational hypertension rate
大体时间:delivery
|
defined with blood pressure over 140/90 mmhg from gestational week 20 to delivery with or without other complications by the enrolled patients
|
delivery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The pre-eclampsia rate
大体时间:From gestational week 20 to delivery
|
Preeclampsia is defined using the current American College of Obstetricians and Gynecologists definitions (Gynecologists; and Pregnancy 2013)
|
From gestational week 20 to delivery
|
合作者和调查者
调查人员
- 首席研究员:Dan Zhang, M.D. Ph.D.、Women's Hospital School Of Medicine Zhejiang University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- PREECLAMPSIA (Al-Ahliyya Amman University)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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