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Warm Contrast Media for Pain Reduction During Hystersalpingography

NCT ID: NCT00391781

Last Updated: 2007-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-12-31

Brief Summary

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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

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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.

Conditions

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Infertility

Keywords

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mechanical infertility hysterosalpingogram hysterosalpingography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Temperature of contrast medium

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* active pelvic inflammotory disease
* known sensitivity to contrast medium
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Avi Tsafrir, MD

Role: PRINCIPAL_INVESTIGATOR

Shaare Zedek Medical Center

Locations

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women's health center, Ramot Eshkol

Jerusalem, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Avi Tsafrir, MD

Role: CONTACT

Phone: 972-508685802

Email: [email protected]

Facility Contacts

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Avi Tsafrir, MD

Role: primary

References

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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. doi: 10.1093/humrep/dei440. Epub 2005 Dec 22.

Reference Type BACKGROUND
PMID: 16373408 (View on PubMed)

Other Identifiers

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WARMHSG.CTIL

Identifier Type: -

Identifier Source: org_study_id