A Trial to Compare Three Methods of Performing Hysterosalpingography

December 2, 2010 updated by: IRCCS Burlo Garofolo

A Prospective, Randomized Study to Compare the Efficacy and the Tolerability of Three Methods of Performing Hysterosalpingography

The purpose of this study is:

  • to determine whether the choice of the device for performing hysterosalpingography on the basis of the cervix characteristics can reduce the procedure failure rate;
  • to determine whether patient medical history is correlated with the degree of pain experienced during the HSG procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A group of women will be randomized to undergo HSG, using 1) a balloon catheter in a first group of patients; 2) a cervical vacuum cup in a second group; 3) one of the two devices decided by the operator depending on the cervix characteristics in a third group (that will be named "operator's choice").

The operator will ask the woman to evaluate the degree of pain experienced during the application of the device and the injection of the contrast, after 2, 6 and 24 hours. The degree of pain will be evaluated using the VAS system, an analogue scale rating from 1 to 10.

A nurse will notice the patient's reaction and will evaluate the pain, depending on the movements of the hands and the body and the woman's moaning. Moreover, the assistant will note down the personal data and the history of the patient. The operator will record the objective and subjective difficulty of the performance, using a rating scale from 0 to 9. The length of the procedure, the volume of contrast used, the amount of radiations and the time of exposure of the patient will also be considered.

At the end of HSG both the gynaecologist and the radiologist will express their satisfaction upon the examination with a score from 0 to 10.

Study Type

Interventional

Enrollment (Anticipated)

222

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

  • Italy
      • Trieste, Italy, 3438
        • IRCCS Burlo Garofolo

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

25 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • infertility

Exclusion Criteria:

  • hypersensitivity to iodine or radio-opaque contrast dye
  • cervicitis
  • genital bleeding
  • genital malignancy

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Balloon catheter
Hysterosalpingography using intrauterine Balloon catheter
Procedure: Balloon catheter
Hysterosalpingography is performed using intrauterine balloon catheter
Active Comparator: Cervical vacuum cup
Hysterosalpingography using cervical vacuum cup
Procedure: Cervical vacuum cup
Hysterosalpingography is performed using cervical vacuum cup
Experimental: Operator choice
Hysterosalpingography is performed using either balloon catheter or cervical vacuum cup on the basis of the operator's choice
Procedure: Balloon catheter
Hysterosalpingography is performed using intrauterine balloon catheter
Procedure: Cervical vacuum cup
Hysterosalpingography is performed using cervical vacuum cup

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
failure rate to complete hysterosalpingography (HSG)
Time Frame: two years
two years

Secondary Outcome Measures

Outcome Measure
Time Frame
the objective difficulty to perform HSG
Time Frame: two years
two years
the subjective difficulty to perform HSG
Time Frame: two years
two years
the fluoroscopic time
Time Frame: two years
two years
the length of the procedure of device application
Time Frame: two years
two years
the volume of contrast medium used
Time Frame: two years
two years
gynecologist satisfaction with the procedure
Time Frame: two years
two years
radiologist satisfaction with the procedure
Time Frame: two years
two years
the percentage of short-term complications
Time Frame: two years
two years
the percentage of long-term complications
Time Frame: two years
two years
correlation between patient medical history and the degree of pain experienced during the HSG procedure
Time Frame: two years
two years
the degree of pain experienced during the HSG procedure
Time Frame: two years
two years

Collaborators and Investigators

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

Sponsor

IRCCS Burlo Garofolo

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

August 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

March 26, 2009

First Submitted That Met QC Criteria

March 26, 2009

First Posted (Estimate)

March 27, 2009

Study Record Updates

Last Update Posted (Estimate)

December 3, 2010

Last Update Submitted That Met QC Criteria

December 2, 2010

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RU02/07

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.

Clinical Trials on Infertility

Clinical Trials on Balloon catheter

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe