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A Trial to Compare Three Methods of Performing Hysterosalpingography

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Balloon catheter
Cervical vacuum cup
Sponsored by
IRCCS Burlo Garofolo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infertility focused on measuring Balloon catheter, Cervical vacuum cup, Hysterosalpingography, Infertility, Pain, Fallopian Tube Patency Tests, Female Infertility

Eligibility Criteria

25 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • infertility

Exclusion Criteria:

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

Sites / Locations

  • IRCCS Burlo Garofolo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Balloon catheter

Cervical vacuum cup

Operator choice

Arm Description

Hysterosalpingography using intrauterine Balloon catheter

Hysterosalpingography using cervical vacuum cup

Hysterosalpingography is performed using either balloon catheter or cervical vacuum cup on the basis of the operator's choice

Outcomes

Primary Outcome Measures

failure rate to complete hysterosalpingography (HSG)

Secondary Outcome Measures

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

Full Information

First Posted
March 26, 2009
Last Updated
December 2, 2010
Sponsor
IRCCS Burlo Garofolo
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1. Study Identification

Unique Protocol Identification Number
NCT00870935
Brief Title
A Trial to Compare Three Methods of Performing Hysterosalpingography
Official Title
A Prospective, Randomized Study to Compare the Efficacy and the Tolerability of Three Methods of Performing Hysterosalpingography
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
IRCCS Burlo Garofolo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Balloon catheter, Cervical vacuum cup, Hysterosalpingography, Infertility, Pain, Fallopian Tube Patency Tests, Female Infertility

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
222 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Balloon catheter
Arm Type
Active Comparator
Arm Description
Hysterosalpingography using intrauterine Balloon catheter
Arm Title
Cervical vacuum cup
Arm Type
Active Comparator
Arm Description
Hysterosalpingography using cervical vacuum cup
Arm Title
Operator choice
Arm Type
Experimental
Arm Description
Hysterosalpingography is performed using either balloon catheter or cervical vacuum cup on the basis of the operator's choice
Intervention Type
Procedure
Intervention Name(s)
Balloon catheter
Intervention Description
Hysterosalpingography is performed using intrauterine balloon catheter
Intervention Type
Procedure
Intervention Name(s)
Cervical vacuum cup
Intervention Description
Hysterosalpingography is performed using cervical vacuum cup
Primary Outcome Measure Information:
Title
failure rate to complete hysterosalpingography (HSG)
Time Frame
two years
Secondary Outcome Measure Information:
Title
the objective difficulty to perform HSG
Time Frame
two years
Title
the subjective difficulty to perform HSG
Time Frame
two years
Title
the fluoroscopic time
Time Frame
two years
Title
the length of the procedure of device application
Time Frame
two years
Title
the volume of contrast medium used
Time Frame
two years
Title
gynecologist satisfaction with the procedure
Time Frame
two years
Title
radiologist satisfaction with the procedure
Time Frame
two years
Title
the percentage of short-term complications
Time Frame
two years
Title
the percentage of long-term complications
Time Frame
two years
Title
correlation between patient medical history and the degree of pain experienced during the HSG procedure
Time Frame
two years
Title
the degree of pain experienced during the HSG procedure
Time Frame
two years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: infertility Exclusion Criteria: hypersensitivity to iodine or radio-opaque contrast dye cervicitis genital bleeding genital malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Ricci, MD
Organizational Affiliation
IRCCS Burlo Garofolo
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Burlo Garofolo
City
Trieste
ZIP/Postal Code
3438
Country
Italy

12. IPD Sharing Statement

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A Trial to Compare Three Methods of Performing Hysterosalpingography

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