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临床试验/NCT01334762
NCT01334762已完成不适用

Letrozole and CC Alone in an IUI Program in Women With Surgically Treated Minimal to Mild Endometriosis

Mansoura University1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2007年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
136
试验地点
1
主要终点
Clinical pregnancy rate per cycle

研究概览

简要总结

To evaluate pregnancy rates with letrozole and CC alone in an IUI program for women with recently surgically treated minimal to mild endometriosis.

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
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 36 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patient with minimal-mild endometriosis recently treated by laparoscopy with a waiting period of 6 to 12 months following the procedure
  • No other infertility factors.
  • Normal serum basal hormone levels as well as documented ovulation

排除标准

  • Moderate or severe endometriosis
  • Dense adnexal and/or ovarian adhesions due to pelvic inflammatory disease or previous pelvic surgery
  • Age more than 36 years, BMI more than 30 kg/m2
  • women with a previous pregnancy

研究组 & 干预措施

Letrozole/IUI

Experimental

Patients received 5 mg letrozole daily for 5 days. A single insemination was performed 32-36 hours after hCG (10,000 IU, IM). Patients underwent up to four cycles of treatment.

干预措施: Letrozole/IUI (Drug)

CC/IUI

Active Comparator

Patients received 100 mg CC daily for 5 days. A single insemination was performed 32-36 hours after hCG (10,000 IU, IM). Patients underwent up to four cycles of treatment.

干预措施: CC/IUI (Drug)

结局指标

主要结局

Clinical pregnancy rate per cycle

时间窗: 6-7 weeks gestation

次要结局

  • Miscarriage rate.(Up to 20 weeks gestation)

研究者

申办方类型
Other

研究点 (1)

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