Clinical trial NCT00870935: A Trial to Compare Three Methods of Performing Hysterosalpingography
Official title: A Prospective, Randomized Study to Compare the Efficacy and the Tolerability of Three Methods of Performing Hysterosalpingography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Balloon catheter
Cervical vacuum cup
Hysterosalpingography
Infertility
Pain
Fallopian Tube Patency Tests
Female Infertility
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2009-03-27
Enrollment: 222
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* infertility

Exclusion Criteria:

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

Primary outcomes:
measure: failure rate to complete hysterosalpingography (HSG)
timeFrame: two years
Secondary outcomes:
measure: the objective difficulty to perform HSG
timeFrame: two years
measure: the subjective difficulty to perform HSG
timeFrame: two years
measure: the fluoroscopic time
timeFrame: two years
measure: the length of the procedure of device application
timeFrame: two years
measure: the volume of contrast medium used
timeFrame: two years
measure: gynecologist satisfaction with the procedure
timeFrame: two years
measure: radiologist satisfaction with the procedure
timeFrame: two years
measure: the percentage of short-term complications
timeFrame: two years
measure: the percentage of long-term complications
timeFrame: two years
measure: correlation between patient medical history and the degree of pain experienced during the HSG procedure
timeFrame: two years
measure: the degree of pain experienced during the HSG procedure
timeFrame: two years
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: IRCCS Burlo Garofolo
Study officials:
affiliation: IRCCS Burlo Garofolo
name: Giuseppe Ricci, MD
role: PRINCIPAL_INVESTIGATOR
References: