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A Trial to Compare Three Methods of Performing Hysterosalpingography

NCT ID: NCT00870935

Last Updated: 2010-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-09-30

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.

Conditions

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Infertility

Keywords

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Balloon catheter Cervical vacuum cup Hysterosalpingography Infertility Pain Fallopian Tube Patency Tests Female Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Balloon catheter

Hysterosalpingography using intrauterine Balloon catheter

Group Type ACTIVE_COMPARATOR

Balloon catheter

Intervention Type PROCEDURE

Hysterosalpingography is performed using intrauterine balloon catheter

Cervical vacuum cup

Hysterosalpingography using cervical vacuum cup

Group Type ACTIVE_COMPARATOR

Cervical vacuum cup

Intervention Type PROCEDURE

Hysterosalpingography is performed using cervical vacuum cup

Operator choice

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

Group Type EXPERIMENTAL

Balloon catheter

Intervention Type PROCEDURE

Hysterosalpingography is performed using intrauterine balloon catheter

Cervical vacuum cup

Intervention Type PROCEDURE

Hysterosalpingography is performed using cervical vacuum cup

Interventions

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Balloon catheter

Hysterosalpingography is performed using intrauterine balloon catheter

Intervention Type PROCEDURE

Cervical vacuum cup

Hysterosalpingography is performed using cervical vacuum cup

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* infertility

Exclusion Criteria

* hypersensitivity to iodine or radio-opaque contrast dye
* cervicitis
* genital bleeding
* genital malignancy
Minimum Eligible Age

25 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Burlo Garofolo

OTHER

Sponsor Role lead

Responsible Party

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IRCCS Burlo Garofolo

Principal Investigators

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Giuseppe Ricci, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Burlo Garofolo

Locations

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IRCCS Burlo Garofolo

Trieste, , Italy

Site Status

Countries

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Italy

Other Identifiers

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RU02/07

Identifier Type: -

Identifier Source: org_study_id