A Trial to Compare Three Methods of Performing Hysterosalpingography

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infertility

Intervention / Treatment
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* Procedure: Balloon catheter
* Procedure: Cervical vacuum cup


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: infertility Exclusion Criteria: hypersensitivity to iodine or radio-opaque contrast dye cervicitis genital bleeding genital malignancy

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| failure rate to complete hysterosalpingography (HSG) |  | two years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Balloon catheter, Cervical vacuum cup, Hysterosalpingography, Infertility, Pain, Fallopian Tube Patency Tests, Female Infertility