Thin Catheter for Hysterosalpigography
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HSG cannula
Sponsored by
About this trial
This is an interventional supportive care trial for Infertility focused on measuring hysterosalpingography, catheter, pain, visual analogue scale
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
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
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
Learn more about this trial
Thin Catheter for Hysterosalpigography
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