A Trial to Compare Three Methods of Performing Hysterosalpingography

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Procedure: Balloon catheter; Procedure: Cervical vacuum cup

• Registration Number: NCT00870935
• Lead Sponsor: IRCCS Burlo Garofolo

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 Timeline

• Study Start: 2007-08
• Status Verified: 2009-03
• Study First Submitted: 2009-03-26
• Study First Submitted QC: 2009-03-26
• Study First Posted: 2009-03-27
• Primary Completion: 2009-08
• Study Completion: 2009-09
• Last Update Submitted: 2010-12-02
• Last Update Posted: 2010-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 222

Inclusion Criteria

• infertility

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Balloon catheter	Balloon catheter	Hysterosalpingography using intrauterine Balloon catheter
Cervical vacuum cup	Cervical vacuum cup	Hysterosalpingography using cervical vacuum cup
Operator choice	Balloon catheter	Hysterosalpingography is performed using either balloon catheter or cervical vacuum cup on the basis of the operator's choice
Operator choice	Cervical vacuum cup	Hysterosalpingography is performed using either balloon catheter or cervical vacuum cup on the basis of the operator's choice

Primary Outcome Measures

Name	Time	Method
failure rate to complete hysterosalpingography (HSG)	two years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

IRCCS Burlo Garofolo; 🇮🇹 Trieste, Italy