Thin Catheter for Hysterosalpigography

Study Overview
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Brief Summary
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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
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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.

Official Title
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Hysterosalpigography Using a Thin Catheter and Closing the Cervix With the Vaginal Speculum to Reduce the Pain

Conditions
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Infertility

Intervention / Treatment
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* Device: HSG cannula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: infertile women seeking evaluation of fallopian tubes Exclusion Criteria: any woman with allergy to the iodine dye or condition contraindicating pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: infertile women<br>infertile women undergoing hysterosalpingography for evaluating fallopian tubes | Device: HSG cannula<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 8 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visualising uterus and tubes | the efficiency of the new technique in filling the uterine cavity with the dye and studying fallopian tubes. | 8 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hysterosalpingography, catheter, pain, visual analogue scale