Warm Contrast Media for Pain Reduction During Hystersalpingography
Primary Purpose
Infertility
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Temperature of contrast medium
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring mechanical infertility, hysterosalpingogram, hysterosalpingography
Eligibility Criteria
Inclusion Criteria:
- Diagnosis: infertility
- sex: female
- age: 18-45
Exclusion Criteria:
- active pelvic inflammotory disease
- known sensitivity to contrast medium
Sites / Locations
- women's health center, Ramot EshkolRecruiting
Outcomes
Primary Outcome Measures
Pain level
Secondary Outcome Measures
Full Information
NCT ID
NCT00391781
First Posted
October 23, 2006
Last Updated
September 24, 2007
Sponsor
Shaare Zedek Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00391781
Brief Title
Warm Contrast Media for Pain Reduction During Hystersalpingography
Official Title
Prospective Randomised Controlled Trian of Warmed vs. Room Temperature Contrast Media for Hystersalpingography
Study Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Unknown status
Study Start Date
December 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Shaare Zedek Medical Center
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
mechanical infertility, hysterosalpingogram, hysterosalpingography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Temperature of contrast medium
Primary Outcome Measure Information:
Title
Pain level
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis: infertility
sex: female
age: 18-45
Exclusion Criteria:
active pelvic inflammotory disease
known sensitivity to contrast medium
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Avi Tsafrir, MD
Phone
972-508685802
Email
avits@netvision.net.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avi Tsafrir, MD
Organizational Affiliation
Shaare Zedek Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
women's health center, Ramot Eshkol
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avi Tsafrir, MD
Phone
050-8573805
Email
avits@szmc.org.il
12. IPD Sharing Statement
Citations:
PubMed Identifier
16373408
Citation
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. doi: 10.1093/humrep/dei440. Epub 2005 Dec 22.
Results Reference
background
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Warm Contrast Media for Pain Reduction During Hystersalpingography
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