Thin Catheter for Hysterosalpigography

• ClinicalTrials.gov Identifier: NCT03826823
• Recruitment Status: Completed
• First Posted: February 1, 2019
• Last Update Posted: February 1, 2019
• Sponsor: Cairo University
• Information provided by (Responsible Party): Ragaa Mansour, The Egyptian IVF-ET Center

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

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• infertile women seeking evaluation of fallopian tubes

Exclusion Criteria:

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Ragaa Mansour, Director, The Egyptian IVF-ET Center
• ClinicalTrials.gov Identifier: NCT03826823
• Other Study ID Numbers: 1-Mansour
• First Posted: February 1, 2019
• 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:

Infertility