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Completed

NCT Number: NCT00870935

A Trial to Compare 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.

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Key information

Age range

25 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Burlo Garofolo

Trieste, 3438, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • infertility

Exclusion criteria

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

Treatment and study plan

balloon catheter

Procedure

Hysterosalpingography is performed using intrauterine balloon catheter

Cervical vacuum cup

Procedure

Hysterosalpingography is performed using cervical vacuum cup

Primary outcomes

  1. failure rate to complete hysterosalpingography (HSG)

    Time frame: two years

Secondary outcomes

  1. the objective difficulty to perform HSG

    Time frame: two years

  2. the subjective difficulty to perform HSG

    Time frame: two years

  3. the fluoroscopic time

    Time frame: two years

  4. the length of the procedure of device application

    Time frame: two years

  5. the volume of contrast medium used

    Time frame: two years

  6. gynecologist satisfaction with the procedure

    Time frame: two years

  7. radiologist satisfaction with the procedure

    Time frame: two years

  8. the percentage of short-term complications

    Time frame: two years

  9. the percentage of long-term complications

    Time frame: two years

  10. correlation between patient medical history and the degree of pain experienced during the HSG procedure

    Time frame: two years

  11. the degree of pain experienced during the HSG procedure

    Time frame: two years

Sponsors and collaborators

Lead sponsor

IRCCS Burlo Garofolo

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 27, 2009
Registry last updated
Dec 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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