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A Trial to Compare Three Methods of Performing Hysterosalpingography

This study has been completed.
Sponsor:
Information provided by:
IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier:
NCT00870935
First received: March 26, 2009
Last updated: December 2, 2010
Last verified: March 2009

March 26, 2009
December 2, 2010
August 2007
August 2009   (final data collection date for primary outcome measure)
failure rate to complete hysterosalpingography (HSG) [ Time Frame: two years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00870935 on ClinicalTrials.gov Archive Site
  • the objective difficulty to perform HSG [ Time Frame: two years ] [ Designated as safety issue: No ]
  • the subjective difficulty to perform HSG [ Time Frame: two years ] [ Designated as safety issue: No ]
  • the fluoroscopic time [ Time Frame: two years ] [ Designated as safety issue: Yes ]
  • the length of the procedure of device application [ Time Frame: two years ] [ Designated as safety issue: No ]
  • the volume of contrast medium used [ Time Frame: two years ] [ Designated as safety issue: No ]
  • gynecologist satisfaction with the procedure [ Time Frame: two years ] [ Designated as safety issue: No ]
  • radiologist satisfaction with the procedure [ Time Frame: two years ] [ Designated as safety issue: No ]
  • the percentage of short-term complications [ Time Frame: two years ] [ Designated as safety issue: Yes ]
  • the percentage of long-term complications [ Time Frame: two years ] [ Designated as safety issue: Yes ]
  • correlation between patient medical history and the degree of pain experienced during the HSG procedure [ Time Frame: two years ] [ Designated as safety issue: No ]
  • the degree of pain experienced during the HSG procedure [ Time Frame: two years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Trial to Compare Three Methods of Performing Hysterosalpingography
A Prospective, Randomized Study to Compare the Efficacy and the Tolerability of Three Methods of Performing Hysterosalpingography

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Infertility
  • Procedure: Balloon catheter
    Hysterosalpingography is performed using intrauterine balloon catheter
  • Procedure: Cervical vacuum cup
    Hysterosalpingography is performed using cervical vacuum cup
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
222
September 2009
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • infertility

Exclusion Criteria:

  • hypersensitivity to iodine or radio-opaque contrast dye
  • cervicitis
  • genital bleeding
  • genital malignancy
Female
25 Years to 42 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00870935
RU02/07
No
Giuseppe Ricci, IRCCS Burlo Garofolo
IRCCS Burlo Garofolo
Not Provided
Principal Investigator: Giuseppe Ricci, MD IRCCS Burlo Garofolo
IRCCS Burlo Garofolo
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP