RCT on the Effect of Endometrial Injury on Ongoing Pregnancy Rate in Subfertile Women Undergoing IVF
A Randomized Controlled Trial on the Effect of Endometrial Injury on Improving Ongoing Pregnancy Rate in Subfertile Women Undergoing in Vitro Fertilization Treatment
研究概览
详细说明
Consecutive women attending subfertility clinic at Queen Mary Hospital, University of Hong Kong who are scheduled for IVF treatment will be recruited. Women who have normal uterine cavity will be randomized into study and control groups in 1 to 1 ratio according to a computer-generated randomization list. Patients will be stratified according to the first or repeated cycle.
For patients in the study group, in the cycle immediately preceding the scheduled IVF treatment, LH surge will be determined by daily serum LH level starting from 18 days before the next expected period. LH surge is defined as an elevation of LH to 2 times the level of the average of the previous 3 days and the absolute level of the LH should be more than or equal to 20 IU/L. Women randomized into the study group will have endometrial biopsy performed by pipelle 7 days after the LH surge (LH+7) and they will be instructed to use non-hormonal means of contraception during that cycle. All patients will then proceed to IVF treatment in the next cycle as scheduled. They will receive standard ovarian stimulation according to the departmental protocol and have a maximum of two embryos replaced 2 days after the oocyte retrieval. On-going pregnancy rates between the two groups will be compared.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Hong Kong、香港
- University of Hong Kong
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Undergoing IVF for tubal, unexplained or male factor subfertility
- Normal uterine cavity as shown on saline sonogram / hysteroscopy done at baseline
Exclusion Criteria:
- Presence of hydrosalpinx
- Presence of endometrial polyp or fibroid distorting uterine cavity
- IVF cycles carried out for preimplantation genetic diagnosis
- Use of donor gametes
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:Endometrial Aspirate (EA) group
Endometrial aspirate by pipelle
|
Endometrial aspiration by pipelle is to be performed on LH+7 in the cycle preceding scheduled IVF treatment
|
|
无干预:Control group
No intervention prior to scheduled IVF
|
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 |
|---|---|---|
|
Ongoing pregnancy rate
大体时间:10-12 weeks gestation
|
Ongoing pregnancy rate per fresh embryo transfer
|
10-12 weeks gestation
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
implantation rate
大体时间:4 weeks after embryo transfer
|
number of gestation sac on pelvic scan per number of embryo transferred
|
4 weeks after embryo transfer
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Clinical pregnancy rate
大体时间:4 weeks after embryo transfer
|
Presence of at least one fetal heart pulsation per fresh embryo transfer 4 weeks after transfer
|
4 weeks after embryo transfer
|
合作者和调查者
调查人员
- 首席研究员:Tracy Yeung, MRCOG、The University of Hong Kong
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
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 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.