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临床试验/NCT03580031
NCT03580031已完成4 期

Booster Dose of Human Chorionic Gonadotrophin for Unruptured Follicle in Non IVF/ICSI Cycles: A Randomized Controlled Study

Tanta University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2018年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
110
试验地点
1
主要终点
Ovulation rate

研究概览

简要总结

This study will be conducted to assess the effect of booster dose of hCG on the unruptured follicles in non IVF/ICSI cycles.

详细描述

In this study enrolled patients (n=160) who underwent controlled ovarian stimulation and timed intercourse with unruptured mature graffian follicle 48 hours after IM 10,000 IU HCG dose. Patients were allocated randomly into intervention group and control group. In the intervention group another booster dose (10,000 IU of hCG) was given IM while in the control group 2 ml normal saline was given IM leaving follicles for spontaneous rupture

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
Double (Participant, Investigator)

盲法说明

Double blinded

入排标准

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

入选标准

  • Ordinary stimulated cycles
  • IUI stimulated cycles
  • Unruptured follicle after 10000 IU IM HCG triggering

排除标准

  • IVF/ICSI cycles

研究组 & 干预措施

Study group

Experimental

HCG IM 10,000 IU Im 48 hours after first triggering dose

干预措施: hCG (Drug)

Control group

Placebo Comparator

Saline 2m Injection im 48 hours after the first triggering dose

干预措施: Saline Solution (Drug)

结局指标

主要结局

Ovulation rate

时间窗: 48 hours

rupture of dominant follicle manifested by disappearance of follicle and presence of free fluid in douglas pouch

次要结局

  • Pregnancy rate(15 days)

研究者

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

Ayman S Dawood, MD

Lecturer

Tanta University

研究点 (1)

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