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临床试验/NCT02787811
NCT02787811已完成不适用

Factors Affecting Success of IUI in Women With Unexplained Infertility

Cairo University0 个研究点目标入组 100 人开始时间: 2016年5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
100
主要终点
chemical pregnancy rate

研究概览

简要总结

Superovulation will be conducted with 100 mg of oral clomiphene citrate (Clomifene; Young Poong Pharmaceutical, Incheon, Korea) for 5 days starting on day 3 of the menstrual cycle, followed by daily injection of 150 IU of human menopausal gonadotropin (hMG;Menogon; FerringPharamceutical Co, Germany). When more than 2 dominant follicles reached a diameter of 17 mm or the urinary specimen showed positive results for luteinizing hormone (LH) surge, 5000 IU of hCG (Pregnyl; Organon, Oss, the Netherlands) was injected intramuscularly.

详细描述

Superovulation will conducted with 100 mg of oral clomiphene citrate (Clomifene; Young Poong Pharmaceutical, Incheon, Korea) for 5 days starting on day 3 of the menstrual cycle, followed by daily injection of 150 IU of human menopausal gonadotropin (hMG;Menogon; FerringPharamceutical Co, Germany). When more than 2 dominant follicles reached a diameter of 17 mm or the urinary specimen showed positive results for luteinizing hormone (LH) surge, 5000 IU of hCG (Pregnyl; Organon, Oss, the Netherlands) was injected intramuscularly. Successful pregnancy after IUI was confirmed by ultrasound as one or more visible gestational sacs in the uterine cavity.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •These patients had at least 1 tube patent
  • •there were no significant intrauterine or pelvic abnormalities demonstrated on pelvic-abdominal ultrasonography, hysteroscopy, and/or laparoscopy
  • •serum follicular stimulating hormone (FSH) level of12 mIU/mL or less

排除标准

  • •A woman's age of more than 40 years,
  • •ovarian cyst detected in the ultrasound examination
  • •uterine lesions such as submucosal leiomyoma, and a previous diagnosis of moderate to severe pelvic endometriosis.
  • •women with body mass index > 35 kg/m2,
  • •PCOS/anovulatory patients
  • •signs of hyperandrogenemia

研究组 & 干预措施

Pregnant

Active Comparator

women with positive serum beta HCG done 14 days after Intrauterine insemenation

干预措施: Intrauterine insemenation (Device)

Nonpregnant

Active Comparator

women with negative serum beta HCG done 14 days after Intrauterine insemenation

干预措施: Intrauterine insemenation (Device)

结局指标

主要结局

chemical pregnancy rate

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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