A Trial to Compare Three Methods of Performing Hysterosalpingography

Tracking Information
First Submitted Date ICMJE	March 26, 2009
First Posted Date ICMJE	March 27, 2009
Last Update Posted Date	December 3, 2010
Study Start Date ICMJE	August 2007
Actual Primary Completion Date	August 2009 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 26, 2009)	failure rate to complete hysterosalpingography (HSG) [ Time Frame: two years ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00870935 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: March 26, 2009)	the objective difficulty to perform HSG [ Time Frame: two years ]; the subjective difficulty to perform HSG [ Time Frame: two years ]; the fluoroscopic time [ Time Frame: two years ]; the length of the procedure of device application [ Time Frame: two years ]; the volume of contrast medium used [ Time Frame: two years ]; gynecologist satisfaction with the procedure [ Time Frame: two years ]; radiologist satisfaction with the procedure [ Time Frame: two years ]; the percentage of short-term complications [ Time Frame: two years ]; the percentage of long-term complications [ Time Frame: two years ]; correlation between patient medical history and the degree of pain experienced during the HSG procedure [ Time Frame: two years ]; the degree of pain experienced during the HSG procedure [ Time Frame: two years ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	A Trial to Compare Three Methods of Performing Hysterosalpingography
Official Title ICMJE	A Prospective, Randomized Study to Compare the Efficacy and the Tolerability of Three Methods of Performing Hysterosalpingography
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 Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
Condition ICMJE	Infertility
Intervention ICMJE	Procedure: Balloon catheter Hysterosalpingography is performed using intrauterine balloon catheter; Procedure: Cervical vacuum cup Hysterosalpingography is performed using cervical vacuum cup
Study Arms	Active Comparator: Balloon catheter Hysterosalpingography using intrauterine Balloon catheter Intervention: Procedure: Balloon catheter; Active Comparator: Cervical vacuum cup Hysterosalpingography using cervical vacuum cup Intervention: Procedure: Cervical vacuum cup; Experimental: Operator choice Hysterosalpingography is performed using either balloon catheter or cervical vacuum cup on the basis of the operator's choice Interventions: Procedure: Balloon catheter Procedure: Cervical vacuum cup
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Estimated Enrollment ICMJE; (submitted: March 26, 2009)	222
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	September 2009
Actual Primary Completion Date	August 2009 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: infertility Exclusion Criteria: hypersensitivity to iodine or radio-opaque contrast dye; cervicitis; genital bleeding; genital malignancy
Sex/Gender	Sexes Eligible for Study: Female
Ages	25 Years to 42 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Italy
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00870935
Other Study ID Numbers ICMJE	RU02/07
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Giuseppe Ricci, IRCCS Burlo Garofolo
Study Sponsor ICMJE	IRCCS Burlo Garofolo
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Giuseppe Ricci, MD IRCCS Burlo Garofolo
PRS Account	IRCCS Burlo Garofolo
Verification Date	March 2009
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP