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临床试验/NCT02349750
NCT02349750已完成不适用

Endometrial Scratch Injury Induced Higher Pregnancy Rate for Women With Unexplained Infertility Undergoing IUI With Ovarian Stimulation

Cairo University0 个研究点目标入组 154 人开始时间: 2010年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
154
主要终点
clinical pregnancy

研究概览

简要总结

The study included 154 infertile women Patients received 100 mg of oral clomiphene citrate for five days starting on day 3 of the menstrual cycle, followed by daily injection of 150 IU of hMG and when more than two dominant follicles reached a diameter of 17 mm 5,000 IU of hCG was injected intramuscularly. Patients were randomly allocated into two equal groups: Group C received IUI without ESI and Group S had ESI using No.8 neonatal feeding tube and after 24 to 36 hours, IUI was performed. Successful pregnancy was con-firmed by ultrasound and patients had failed trial underwent another trial of IUI for a maximum of three trials.

详细描述

The study included 154 infertile women with mean duration of infertility of 3.9±0.4 years. Patients received 100 mg of oral clomiphene citrate for five days starting on day 3 of the menstrual cycle, followed by daily injection of 150 IU of hMG and when more than two dominant follicles reached a diameter of 17 mm 5,000 IU of hCG was injected intramuscularly. Patients were randomly allocated into two equal groups: Group C received IUI without ESI and Group S had ESI using No.8 neonatal feeding tube and after 24 to 36 hours, IUI was performed. Successful pregnancy was con-firmed by ultrasound and patients had failed trial underwent another trial of IUI for a maximum of three trials.

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

  • •Couple with unexplained infertility and assigned for IUI

排除标准

  • •Woman's age of more than 40 years
  • •Ovarian cyst detected in the ultrasound examination
  • •Uterine lesions such as submucosal leiomyoma
  • •A previous diagnosis of moderate to severe pelvic endometriosis
  • •Women with body mass index ≥35 kg/m2 o
  • •Women with signs of hyperandrogenemia dy

研究组 & 干预措施

Non endometrial scratch injury

No Intervention

Patients received 100 mg of oral clomiphene citrate for five days starting on day 3 of the menstrual cycle, followed by daily injection of 150 IU of hMG and when more than two dominant follicles reached a diameter of 17 mm 5,000 IU of hCG was injected intramuscularly. Group C received IUI without ESI and after 24 to 36 hours, IUI was performed.

endometrial scratch injury

Active Comparator

Patients received 100 mg of oral clomiphene citrate for five days starting on day 3 of the menstrual cycle, followed by daily injection of 150 IU of hMG and when more than two dominant follicles reached a diameter of 17 mm 5,000 IU of hCG was injected intramuscularly. Group S had ESI using No.8 neonatal feeding tube and after 24 to 36 hours, IUI was performed.

干预措施: endometrial scratch injury (Procedure)

结局指标

主要结局

clinical pregnancy

时间窗: 14 days after IUI

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Maged

Assistant professor

Cairo University

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