Thin Catheter for Hysterosalpigography

NCT ID: NCT03826823

Last Updated: 2019-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2010-07-31

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.

Conditions

Infertility

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

infertile women

infertile women undergoing hysterosalpingography for evaluating fallopian tubes

Group Type: EXPERIMENTAL

HSG cannula

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ragaa Mansour

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

1-Mansour

Identifier Type: -

Identifier Source: org_study_id