A Prospective, Randomized Study to Compare the Efficacy and the Tolerability of Three Methods of Performing Hysterosalpingography
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 222
- Locations
- 2
- Primary Endpoint
- failure rate to complete hysterosalpingography (HSG)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 42 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •infertility
Exclusion Criteria
- •hypersensitivity to iodine or radio-opaque contrast dye
- •cervicitis
- •genital bleeding
- •genital malignancy
Outcomes
Primary Outcomes
failure rate to complete hysterosalpingography (HSG)
Time Frame: two years
Secondary Outcomes
- 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)