Warm Contrast Media for Pain Reduction During Hystersalpingography - Full Text View

Sponsored by:	Shaare Zedek Medical Center
Information provided by:	Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:	NCT00391781

Purpose

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.

Condition	Intervention
Infertility	Procedure: Temperature of contrast medium

MedlinePlus related topics: Infertility

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Single Group Assignment
Official Title:	Prospective Randomised Controlled Trian of Warmed vs. Room Temperature Contrast Media for Hystersalpingography

Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:

Pain level

Study Start Date:	December 2006
Estimated Study Completion Date:	December 2008

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis: infertility
sex: female
age: 18-45

Exclusion Criteria:

active pelvic inflammotory disease
known sensitivity to contrast medium

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391781

Contacts

Contact: Avi Tsafrir, MD

972-508685802

avits@netvision.net.il

Locations

Israel
women's health center, Ramot Eshkol	Recruiting
Jerusalem, Israel
Contact: Avi Tsafrir, MD 050-8573805 avits@szmc.org.il

Sponsors and Collaborators

Shaare Zedek Medical Center

Investigators

Principal Investigator:

Avi Tsafrir, MD

Shaare Zedek Medical Center

More Information

Publications:

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.

Study ID Numbers:	WARMHSG.CTIL
Study First Received:	October 23, 2006
Last Updated:	September 24, 2007
ClinicalTrials.gov Identifier:	NCT00391781
Health Authority:	Israel: Ministry of Health

Keywords provided by Shaare Zedek Medical Center:

mechanical infertility
hysterosalpingogram
hysterosalpingography

Study placed in the following topic categories:

Genital Diseases, Female
Infertility
Pain
Genital Diseases, Male

ClinicalTrials.gov processed this record on January 15, 2009