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临床试验/NCT00391781
NCT00391781Unknown不适用

Prospective Randomised Controlled Trian of Warmed vs. Room Temperature Contrast Media for Hystersalpingography

Shaare Zedek Medical Center1 个研究点 分布在 1 个国家开始时间: 2006年12月最近更新:
适应症

试验速览

阶段
不适用
试验地点
1
主要终点
Pain level

研究概览

简要总结

The aim of this study is to compare between body-temperature to room-temperature contrast media used during hysterosalpingography. We hypothesize that warmed medium will reduce pain associated with the procedure.

详细描述

Infertility occurs in about 15% of all couples. One of the common methods for evaluation of mechanical infertility is hysterosalpingography (HSG). Several reports have shown that this common procedure is associated with moderate pain, i.e. around 5 on a visual analog scale (VAS)of 1-10. It is therefore important to find modes for pain reduction for HSG. According to a report on sonohydrosonograpy, a similar technique using sonography, insertion of media warmed to body temperature into the uterus significantly reduced the pain during the procedure compared with media at room-temprature. The use of room-temperature media is the routine in our institution, as well as in many others. A comparison between the media at different temperatures has not been reported so far.

We plan to perform a prospective trial in which patients referred for HSG will be randomized to the procedure using either warmed or room-temperature media. we will asses pain levels using VAS during the procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Diagnosis: infertility
  • sex: female
  • age: 18-45

排除标准

  • active pelvic inflammotory disease
  • known sensitivity to contrast medium

结局指标

主要结局

Pain level

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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