Evaluation of Pain During Hysterosalpingography With The Use Of Balloon Catheter Versus Metal Cannula

Not Applicable

Completed

• Conditions: Pain During Hysterosalpingography
• Interventions: Device: Balloon catheter; Device: metal cannula

• Registration Number: NCT02020733
• Lead Sponsor: Sadiman Kiykac Altinbas

Brief Summary

The aim of this study is to compare the metal cannula routinely used in our clinical practice with intrauterine hysterosalpingography catheter as a probable alternative device in a prospective, single-blinded, randomized study.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-12
• Study First Submitted: 2013-12-19
• Study First Submitted QC: 2013-12-24
• Last Update Submitted: 2013-12-24
• Study First Posted: 2013-12-25
• Last Update Posted: 2013-12-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 194

Inclusion Criteria

• Women aged between 18-47 years,
• applying for basic infertility evaluation to the Reproductive Endocrinology unit

Exclusion Criteria

• The patients with a known hypersensitivity to iodine or radio-opaque contrast dye,
• vaginal bleeding,
• genital malignancy and
• any sign of pelvic inflammatory disease (PID) were excluded

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
balloon catheter	Balloon catheter	-
metal cannula	metal cannula	-

Primary Outcome Measures

Name	Time	Method
the degree of pain experienced during the procedure	1 hour after the procedure	The primary outcome was the degree of pain experienced during the procedure, pain was evaluated with the Wong Baker Faces Pain Rating Scale (WBS), which ranked the pain from 0 to 5.

Trial Locations

Locations (1)

Etlik Zubeyde Hanim Women's Health Teaching and Research Hospital; 🇹🇷 Ankara, Turkey