Evaluation of Pain During Hysterosalpingography With The Use Of Balloon Catheter Versus Metal Cannula

December 24, 2013 updated by: Sadiman Kiykac Altinbas
The aim of this study is to compare the metal cannula routinely used in our clinical practice with intrauterine hysterosalpingography catheter as a probable alternative device in a prospective, single-blinded, randomized study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

194

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06010
        • Etlik Zubeyde Hanim Women's Health Teaching and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 47 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women aged between 18-47 years,
  • applying for basic infertility evaluation to the Reproductive Endocrinology unit

Exclusion Criteria:

  • The patients with a known hypersensitivity to iodine or radio-opaque contrast dye,
  • vaginal bleeding,
  • genital malignancy and
  • any sign of pelvic inflammatory disease (PID) were excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: balloon catheter
Device: Balloon catheter
OTHER: metal cannula
Device: metal cannula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the degree of pain experienced during the procedure
Time Frame: 1 hour after the procedure
The primary outcome was the degree of pain experienced during the procedure, pain was evaluated with the Wong Baker Faces Pain Rating Scale (WBS), which ranked the pain from 0 to 5.
1 hour after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sadiman Kiykac Altinbas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ACTUAL)

February 1, 2013

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

December 19, 2013

First Submitted That Met QC Criteria

December 24, 2013

First Posted (ESTIMATE)

December 25, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 25, 2013

Last Update Submitted That Met QC Criteria

December 24, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20.12.13/160

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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