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Thin Catheter for Hysterosalpigography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03826823
Recruitment Status : Completed
First Posted : February 1, 2019
Last Update Posted : February 1, 2019
Information provided by (Responsible Party):
Ragaa Mansour, The Egyptian IVF-ET Center

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

Condition or disease Intervention/treatment Phase
Infertility Device: HSG cannula Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Hysterosalpigography Using a Thin Catheter and Closing the Cervix With the Vaginal Speculum to Reduce the Pain
Study Start Date : February 2010
Actual Primary Completion Date : February 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Experimental: infertile women
infertile women undergoing hysterosalpingography for evaluating fallopian tubes
Device: HSG cannula
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 Measures :
  1. the level of pain using a visual analogue scale (VAS) [ Time Frame: 8 month ]
    pain score will be assessed during introduction of catheter and during the injection of dye

Secondary Outcome Measures :
  1. visualising uterus and tubes [ Time Frame: 8 month ]
    the efficiency of the new technique in filling the uterine cavity with the dye and studying fallopian tubes.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • infertile women seeking evaluation of fallopian tubes

Exclusion Criteria:

  • any woman with allergy to the iodine dye or condition contraindicating pregnancy
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Responsible Party: Ragaa Mansour, Director, The Egyptian IVF-ET Center Identifier: NCT03826823    
Other Study ID Numbers: 1-Mansour
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: March 2008
Keywords provided by Ragaa Mansour, The Egyptian IVF-ET Center:
hysterosalpingography, catheter, pain, visual analogue scale
Additional relevant MeSH terms:
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Genital Diseases, Male
Genital Diseases, Female