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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
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Prospective Randomised Controlled Trian of Warmed vs. Room Temperature Contrast Media for Hystersalpingography

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

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:

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

Keywords provided by Shaare Zedek Medical Center:
mechanical infertility
hysterosalpingogram
hysterosalpingography

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 23, 2013