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临床试验/NCT03920514
NCT03920514Unknown4 期

Different Timing of Intrauterine Insemination and Pregnancy Outcome in Patient With Unexplained Infertility :A Randomized Controlled Study

Sohag University0 个研究点目标入组 80 人开始时间: 2019年4月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
80
主要终点
Primary outcome

研究概览

简要总结

to determine the most suitable time for administration of (human chorionic gonadotropin )hCG prior to intrauterine insemination (IUI) to optimize pregnancy outcome and to have the best success rates so the cases divided in to four groups according to the time of hCG administration .

详细描述

IUI with or without ovarian stimulation is a common treatment for infertility ,it is a simple procedure the semen is prepared in the laboratory and transferred by a catheter and injected intrauterine .ultrasound folliculometry is used for monitoring follicular growth where some clinicians prefer the natural cycles and others prefer ovarian stimulation and human chorionic gonadotropin (hCG)trigger for better timing .so cases will take induction and folliculometry will be done until the follicle reach 18mm trigger with hCG .women will be randomly divided to four groups .the first group will undergo IUI at 24 after trigger the second IUI at36 hour after trigger the thirdG at 48 after trigger and finaly the last group IUI will be done simultaneos with trigger the out come the number of pregnant women for each group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

入排标准

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

入选标准

  • Mild male infertility or unexplained infertility

排除标准

  • Adanced male factor endometriosis uterine abnormality sever semen parameters i impairment according to WHO 2010 non ovulatory cycles bilatral tubal block

研究组 & 干预措施

GROUP 1

Active Comparator

IUI 24 hours after hCGadminstration

干预措施: hCG (Drug)

GROUP 2

Active Comparator

IUI 36 hours after hCG adminstration

干预措施: hCG (Drug)

GROUP 3

Active Comparator

IUI 48 hours after hCG adminstration

干预措施: hCG (Drug)

GROUP 4

Active Comparator

IUI at time of hCG adminstration

干预措施: hCG (Drug)

结局指标

主要结局

Primary outcome

时间窗: 14 days after IUI

Positive serum beta hCG test

Secondary outcome

时间窗: 4 weeks after insemination

Clinical pregnancy defined as prescence of at least one Intrauterine gestational sac with fetal pole on Transvaginal scan

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

Salwa Sabry Ahmed Mohamed

Faculty of medicine sohag university

Sohag University

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