NCT02020733CompletedNot Applicable
Evaluation of Pain During Hysterosalpingography With The Use Of Balloon Catheter Versus Metal Cannula
Sadiman Kiykac Altinbas2 sites in 1 country194 target enrollmentStarted: June 1, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 194
- Locations
- 2
- Primary Endpoint
- the degree of pain experienced during the procedure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 47 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
the degree of pain experienced during the procedure
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Sadiman Kiykac Altinbas
M. D.
Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
Study Sites (2)
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