NCT00391781

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

September 26, 2007

Status Verified

August 1, 2007

First QC Date

October 23, 2006

Last Update Submit

September 24, 2007

Conditions

Infertility

Keywords

mechanical infertilityhysterosalpingogramhysterosalpingography

Outcome Measures

Primary Outcomes (1)

  • Pain level

Interventions

Temperature of contrast mediumPROCEDURE

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • active pelvic inflammotory disease
  • known sensitivity to contrast medium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

women's health center, Ramot Eshkol

Jerusalem, Israel

RECRUITING

Related Publications (1)

  • 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.

    PMID: 16373408BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Avi Tsafrir, MD

    Shaare Zedek Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Avi Tsafrir, MD

CONTACT

972-508685802avits@netvision.net.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 23, 2006

First Posted

October 24, 2006

Study Start

December 1, 2006

Study Completion

December 1, 2008

Last Updated

September 26, 2007

Record last verified: 2007-08

Locations

IL(1)