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Thin Catheter for Hysterosalpigography

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HSG cannula
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infertility focused on measuring hysterosalpingography, catheter, pain, visual analogue scale

Eligibility Criteria

18 Years - 43 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • infertile women seeking evaluation of fallopian tubes

Exclusion Criteria:

  • any woman with allergy to the iodine dye or condition contraindicating pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    infertile women

    Arm Description

    infertile women undergoing hysterosalpingography for evaluating fallopian tubes

    Outcomes

    Primary Outcome Measures

    the level of pain using a visual analogue scale (VAS)
    pain score will be assessed during introduction of catheter and during the injection of dye

    Secondary Outcome Measures

    visualising uterus and tubes
    the efficiency of the new technique in filling the uterine cavity with the dye and studying fallopian tubes.

    Full Information

    First Posted
    July 11, 2011
    Last Updated
    January 30, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03826823
    Brief Title
    Thin Catheter for Hysterosalpigography
    Official Title
    Hysterosalpigography Using a Thin Catheter and Closing the Cervix With the Vaginal Speculum to Reduce the Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2010 (undefined)
    Primary Completion Date
    February 2010 (Actual)
    Study Completion Date
    July 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Hysterosalpingography is usually painful and the use of thin catheters of IUI could be an attractive alternative . we conducted a randomised controlled trial to compare the standard metal cannula to the thin catheter originally manufactured for intrauterine insemination. Pain assessment was done using visual analogue scale
    Detailed Description
    HSG is widely practiced in our country, however, for cost effective reasons, the standard metal cannula is the only method used at our hospital. It is painful procedure because it requires grasping the cervix with a tenaculum and inducing some cervical dilatation during introduction of the cannula. The aim of this pilot study was to modify the technique of HSG using a thinner than normal catheter, and without grasping the cervix with a tenaculum. Leakage of the dye through the cervix was prevented by pressing on the portiovaginalis of the cervix using the vaginal speculum.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility
    Keywords
    hysterosalpingography, catheter, pain, visual analogue scale

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    89 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    infertile women
    Arm Type
    Experimental
    Arm Description
    infertile women undergoing hysterosalpingography for evaluating fallopian tubes
    Intervention Type
    Device
    Intervention Name(s)
    HSG cannula
    Intervention Description
    a thin catheter originally designed for IUI was introduced through the cervical canal into the lower part of the uterine cavity. After introducing the catheter, the screw of the vaginal speculum was loosened to allow the two valves of the speculum to press on the portiovaginalis of the cervix to prevent leakage of the dye. Then the dye was injected slowly and the procedure was watched on the screen and x-ray films were taken.
    Primary Outcome Measure Information:
    Title
    the level of pain using a visual analogue scale (VAS)
    Description
    pain score will be assessed during introduction of catheter and during the injection of dye
    Time Frame
    8 month
    Secondary Outcome Measure Information:
    Title
    visualising uterus and tubes
    Description
    the efficiency of the new technique in filling the uterine cavity with the dye and studying fallopian tubes.
    Time Frame
    8 month

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    43 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: infertile women seeking evaluation of fallopian tubes Exclusion Criteria: any woman with allergy to the iodine dye or condition contraindicating pregnancy

    12. IPD Sharing Statement

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