A Trial to Compare Three Methods of Performing Hysterosalpingography

• 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 ]

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.

• 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

Inclusion Criteria:

• infertility

Exclusion Criteria:

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