Warm Contrast Media for Pain Reduction During Hystersalpingography

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Shaare Zedek Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00391781
First received: October 23, 2006
Last updated: September 24, 2007
Last verified: August 2007

October 23, 2006
September 24, 2007
December 2006
Not Provided
Pain level
Same as current
Complete list of historical versions of study NCT00391781 on ClinicalTrials.gov Archive Site
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Warm Contrast Media for Pain Reduction During Hystersalpingography
Prospective Randomised Controlled Trian of Warmed vs. Room Temperature Contrast Media for Hystersalpingography

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.

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.

Interventional
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Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Infertility
Procedure: Temperature of contrast medium
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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December 2008
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Inclusion Criteria:

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

Exclusion Criteria:

  • active pelvic inflammotory disease
  • known sensitivity to contrast medium
Female
18 Years to 45 Years
No
Contact: Avi Tsafrir, MD 972-508685802 avits@netvision.net.il
Israel
 
NCT00391781
WARMHSG.CTIL
Not Provided
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Shaare Zedek Medical Center
Not Provided
Principal Investigator: Avi Tsafrir, MD Shaare Zedek Medical Center
Shaare Zedek Medical Center
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP