Warm Contrast Media for Pain Reduction During Hystersalpingography

Infertility Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

• NCT number: NCT00391781
• Study type: Interventional
• Source: Shaare Zedek Medical Center
• Contact: Avi Tsafrir, MD
• Phone: 972-508685802
• Email: avits@netvision.net.il
• Status: Recruiting
• Phase: N/A
• Start date: December 2006
• Completion date: December 2008