Warm Contrast Media for Pain Reduction During Hystersalpingography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00391781
Recruitment Status : Unknown
Verified August 2007 by Shaare Zedek Medical Center.
Recruitment status was:  Recruiting
First Posted : October 24, 2006
Last Update Posted : September 26, 2007
Information provided by:
Shaare Zedek Medical Center

October 23, 2006
October 24, 2006
September 26, 2007
December 2006
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Pain level
Same as current
Complete list of historical versions of study NCT00391781 on 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.

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Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Procedure: Temperature of contrast medium
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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 Identifier (NCT Number) in Medline.
Unknown status
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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
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Shaare Zedek Medical Center
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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