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CompletedNCT02020733Updated Dec 25, 2013

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

An interventional study of Balloon catheter and metal cannula in Pain During Hysterosalpingography, sponsored by Sadiman Kiykac Altinbas. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 47 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-12-25.

Sponsored by Sadiman Kiykac Altinbas · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
194
Allocation
Randomized
Ages
18 Years to 47 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Pain During Hysterosalpingography

Keywords

  • Hysterosalpingography
  • balloon catheter
  • metal cannula
  • pain assessment
03

In context

Lead sponsor

This is the only study on the registry with Sadiman Kiykac Altinbas as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 47 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
194 participants (actual)

Study arms

  • Other
    balloon catheter

    Device: Balloon catheter

  • Other
    metal cannula

    Device: metal cannula

Interventions

  • DeviceBalloon catheter
  • Devicemetal cannula
06

What researchers measure

Primary outcomes

  1. the degree of pain experienced during 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.

    Time frame: 1 hour after the procedure

07

Study locations

1 site
  • Etlik Zubeyde Hanim Women's Health Teaching and Research Hospital
    Ankara, 06010, Turkey (Türkiye)
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02020733
Lead sponsor
Sadiman Kiykac Altinbas
Responsible party
Sadiman Kiykac Altinbas (M. D., Etlik Zubeyde Hanim Womens' Health and Teaching Hospital) — Sponsor-investigator
First posted
Dec 25, 2013
Start date
Jun 2012
Primary completion
Feb 2013
Completion
Feb 2013
Last update
Dec 25, 2013
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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