A Trial to Compare Three Methods of Performing Hysterosalpingography

Infertility Clinical Trial

Official title:

A Prospective, Randomized Study to Compare the Efficacy and the Tolerability of Three Methods of Performing Hysterosalpingography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00870935
• Other study ID #: RU02/07
• Status: Completed
• Phase: N/A
• First received: March 26, 2009
• Last updated: December 2, 2010
• Start date: August 2007
• Est. completion date: September 2009

Study information

• Verified date: March 2009
• Source: IRCCS Burlo Garofolo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: September 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 42 Years

Eligibility

Inclusion Criteria:

• infertility

Exclusion Criteria:

• hypersensitivity to iodine or radio-opaque contrast dye

• cervicitis

• genital bleeding

• genital malignancy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• Balloon catheter
Hysterosalpingography is performed using intrauterine balloon catheter
• Cervical vacuum cup
Hysterosalpingography is performed using cervical vacuum cup

Locations

Country	Name	City	State
Italy	IRCCS Burlo Garofolo	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	failure rate to complete hysterosalpingography (HSG)		two years	No
Secondary	the objective difficulty to perform HSG		two years	No
Secondary	the subjective difficulty to perform HSG		two years	No
Secondary	the fluoroscopic time		two years	Yes
Secondary	the length of the procedure of device application		two years	No
Secondary	the volume of contrast medium used		two years	No
Secondary	gynecologist satisfaction with the procedure		two years	No
Secondary	radiologist satisfaction with the procedure		two years	No
Secondary	the percentage of short-term complications		two years	Yes
Secondary	the percentage of long-term complications		two years	Yes
Secondary	correlation between patient medical history and the degree of pain experienced during the HSG procedure		two years	No
Secondary	the degree of pain experienced during the HSG procedure		two years	No