A Trial to Compare Three Methods of Performing Hysterosalpingography

IRCCS Burlo Garofolo

Status: Completed

Conditions: Infertility

Treatments: Procedure: Cervical vacuum cup; Procedure: Balloon catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT00870935

RU02/07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 222 estimated patients

Sex: Female

Ages: 25 to 42 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• infertility

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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222 participants in 3 patient groups

Balloon catheter

Active Comparator group

Description:

Hysterosalpingography using intrauterine Balloon catheter

Treatment:

Procedure: Balloon catheter

Cervical vacuum cup

Active Comparator group

Description:

Hysterosalpingography using cervical vacuum cup

Treatment:

Procedure: Cervical vacuum cup

Operator choice

Experimental group

Description:

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

Treatment:

Procedure: Balloon catheter

Procedure: Cervical vacuum cup