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临床试验/NCT03380364
NCT03380364Unknown不适用

Role of Routine Hysteroscopy in Management of Cases of Unexplained Infertility

Ain Shams University2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2018年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
75
试验地点
2
主要终点
Pregnancy

研究概览

简要总结

The aim of this work is to assess the value of hysteroscopy in unexplained infertility.

详细描述

The diagnosis of unexplained infertility is one of exclusion and is made only after an infertility evaluation has failed to reveal abnormalities. There is no consensus on which tests should be performed before making this diagnosis (Salim et al., 2011).

The Europe society for human and embryology (ESHRE) suggested standard diagnostic tests for infertility evaluation. These tests include semen analysis, demonstration of tubal patency by hystosalpingography (HSG) or laparascopy and laboratory assessment of ovulation (Polisseni et al., 2003). Moreover post coital test has been included by some authors as a fundamental requirement before the diagnosis of unexplained infertility while other authors found that it is unnecessary however conducting additional investigation and treating any abnormalities detected may be effective in management of women with unexplained infertility especially in older couples (Wortman et al., 2013).

For evaluation of the uterine cavity, the basic work-up consists of transvaginal sonography (TVS) with or without the use of saline or gel as a contrast medium, possibly followed by either HSG or hysteroscopy to directly assess the uterine cavity.

Both TVS, as well as saline infusion sonography (SIS) and gel instillation sonography (GIS) are inexpensive, non-invasive and have been shown to be excellent diagnostic tool to detect subtle intrauterine abnormalities (Rodrigues et al., 2014).

However, hysteroscopy allows direct visualization of the endometrial lining and detects multiple lesions and subtle uterine abnormalities that cannot be identified by the previous techniques. Moreover, hysteroscopy enables treatment of small uterine pathology in the same setting. Therefore, it is frequently referred to as the golden standard. Many studies have concluded that whenever laparoscopy is performed, it should be combined with hysteroscopy in order to complete the assessment before starting the infertility treatment (Chan et al., 2011).

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
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • All women aged (20-35) years old.
  • Unexplained infertility

排除标准

  • Female genital tract cancer, including cervical or uterine cancer
  • Active pelvic infection
  • Known uterine factor for infertility.

研究组 & 干预措施

Group Undergoing Hysterosopy

Experimental

This group will include 75 women with unexplained infertility. 5 mm rigid sheath Office hysteroscopy will be performed during the proliferative phaseof the menstrual cycle.

干预措施: hystroscope (Device)

结局指标

主要结局

Pregnancy

时间窗: 6 months

Biochemical and clinical Pregnancy Biochemical pregnancy will be determined by a positive pregnancy test performed 1week after a missed period and clinical pregnancy will be defined by the presence of a gestational sac using transvaginal ultrasound performed 6 weeks after a missed period.

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

Sameh Habib

dr

Ain Shams University

研究点 (2)

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