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A Trial to Compare Three Methods of Performing Hysterosalpingography

This study has been completed.
Sponsor:
Information provided by:
IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier:
NCT00870935
First received: March 26, 2009
Last updated: December 2, 2010
Last verified: March 2009
  Purpose

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.

Condition Intervention
Infertility
Procedure: Balloon catheter
Procedure: Cervical vacuum cup

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Prospective, Randomized Study to Compare the Efficacy and the Tolerability of Three Methods of Performing Hysterosalpingography

Resource links provided by NLM:


Further study details as provided by IRCCS Burlo Garofolo:

Primary Outcome Measures:
  • failure rate to complete hysterosalpingography (HSG) [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the objective difficulty to perform HSG [ Time Frame: two years ] [ Designated as safety issue: No ]
  • the subjective difficulty to perform HSG [ Time Frame: two years ] [ Designated as safety issue: No ]
  • the fluoroscopic time [ Time Frame: two years ] [ Designated as safety issue: Yes ]
  • the length of the procedure of device application [ Time Frame: two years ] [ Designated as safety issue: No ]
  • the volume of contrast medium used [ Time Frame: two years ] [ Designated as safety issue: No ]
  • gynecologist satisfaction with the procedure [ Time Frame: two years ] [ Designated as safety issue: No ]
  • radiologist satisfaction with the procedure [ Time Frame: two years ] [ Designated as safety issue: No ]
  • the percentage of short-term complications [ Time Frame: two years ] [ Designated as safety issue: Yes ]
  • the percentage of long-term complications [ Time Frame: two years ] [ Designated as safety issue: Yes ]
  • correlation between patient medical history and the degree of pain experienced during the HSG procedure [ Time Frame: two years ] [ Designated as safety issue: No ]
  • the degree of pain experienced during the HSG procedure [ Time Frame: two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 222
Study Start Date: August 2007
Study Completion Date: September 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   25 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • infertility

Exclusion Criteria:

  • hypersensitivity to iodine or radio-opaque contrast dye
  • cervicitis
  • genital bleeding
  • genital malignancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00870935

Locations
Italy
IRCCS Burlo Garofolo
Trieste, Italy, 3438
Sponsors and Collaborators
IRCCS Burlo Garofolo
Investigators
Principal Investigator: Giuseppe Ricci, MD IRCCS Burlo Garofolo
  More Information

No publications provided

Responsible Party: Giuseppe Ricci, IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier: NCT00870935     History of Changes
Other Study ID Numbers: RU02/07
Study First Received: March 26, 2009
Last Updated: December 2, 2010
Health Authority: Italy: Ministry of Health

Keywords provided by IRCCS Burlo Garofolo:
Balloon catheter
Cervical vacuum cup
Hysterosalpingography
Infertility
Pain
Fallopian Tube Patency Tests
Female Infertility

Additional relevant MeSH terms:
Infertility
Genital Diseases, Female
Genital Diseases, Male

ClinicalTrials.gov processed this record on November 25, 2014