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
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
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
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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