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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00391781
Enrollment
Unknown
Registered
2006-10-24
Start date
2006-12-31
Completion date
2008-12-31
Last updated
2007-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

mechanical infertility, hysterosalpingogram, hysterosalpingography

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.

Interventions

PROCEDURETemperature of contrast medium

Sponsors

Shaare Zedek Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* active pelvic inflammotory disease * known sensitivity to contrast medium

Design outcomes

Primary

MeasureTime frame
Pain level

Countries

Israel

Contacts

Primary ContactAvi Tsafrir, MD
avits@netvision.net.il972-508685802

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026