Thin Catheter for Hysterosalpigography

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03826823
• Other study ID #: 1-Mansour
• Status: Completed
• Phase: N/A
• Start date: February 2010
• Est. completion date: July 2010

Study information

• Verified date: March 2008
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: July 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

Inclusion Criteria:

• infertile women seeking evaluation of fallopian tubes

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Infertility

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	visualising uterus and tubes	the efficiency of the new technique in filling the uterine cavity with the dye and studying fallopian tubes.	8 month