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临床试验/NCT04179253
NCT04179253已完成不适用

Hysteroscopic Evaluation of Uterine Cavity in Women With Unexplained Infertility

Beni-Suef University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年4月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Abnormal hysteroscopic findings

研究概览

简要总结

Hysteroscopy is still considered the gold standard procedure for uterine cavity exploration. Therefore, many specialists have used hysteroscopy as their first-line of routine exam for infertility patients regardless of guidelines. Thus, scheduling the office micro hysteroscopy as one of the routine steps in the fertility workup program has become mandatory before the final diagnosis of unexplained infertility.

详细描述

Although hysteroscopy is generally accepted as the gold standard in diagnosis and treatment of uterine cavity pathology, many gynecologist are reluctant to perform hysteroscopy as an initial test without a high degree of suspicion for pathology due to the need for anesthesia in an operating room setting. The basic infertility work-up has included a HSG to evaluate the uterine cavity and tubal patency. However, HSG does not allow for simultaneous correction of uterine pathology. Moreover HSG may miss 35% of uterine abnormalities. Hysterolaparoscopy (Pan Endoscopic) approach is better than HSG and should be encouraged as first and final procedure in selected infertile women.

Sonohysterography (SHG) has been proposed as a better diagnostic test of the uterine cavity. However, it also suffers from a sensitivity and specificity inferior to that of hysteroscopy in most studies.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Normal HSG
  • Normal Ultrasound
  • Normal Hormonal Profile
  • Normal Semen

排除标准

  • Abnormal findings in different investigations of infertility

结局指标

主要结局

Abnormal hysteroscopic findings

时间窗: one year

Description of different hysteroscopic abnormalities using micro-office hysteroscope

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

Nesreen Abdel Fattah Abdullah Shehata

Associate Professor in Obstetrics and Gynecology Department

Beni-Suef University

研究点 (1)

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