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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00391781
• Other study ID #: WARMHSG.CTIL
• Status: Recruiting
• Phase: N/A
• First received: October 23, 2006
• Last updated: September 24, 2007
• Start date: December 2006
• Est. completion date: December 2008

Study information

• Verified date: August 2007
• Source: Shaare Zedek Medical Center
• Contact: Avi Tsafrir, MD
• Phone: 972-508685802
• Email: avits[@]netvision.net.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Diagnosis: infertility

• sex: female

• age: 18-45

Exclusion Criteria:

• active pelvic inflammotory disease

• known sensitivity to contrast medium

Study Design

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

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• Temperature of contrast medium

Locations

Country	Name	City	State
Israel	women's health center, Ramot Eshkol	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Nirmal D, Griffiths AN, Jose G, Evans J. Warming Echovist contrast medium for hysterocontrastsonography and the effect on the incidence of pelvic pain. A randomized controlled study. Hum Reprod. 2006 Apr;21(4):1052-4. Epub 2005 Dec 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain level