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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02020733
Recruitment Status : Completed
First Posted : December 25, 2013
Last Update Posted : December 25, 2013
Sponsor:
Information provided by (Responsible Party):
Sadiman Kiykac Altinbas, Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital

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.

Condition or disease Intervention/treatment Phase
Pain During Hysterosalpingography Device: Balloon catheter Device: metal cannula Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Study Start Date : June 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Arm Intervention/treatment
balloon catheter Device: Balloon catheter
metal cannula Device: metal cannula



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 47 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020733


Locations
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Turkey
Etlik Zubeyde Hanim Women's Health Teaching and Research Hospital
Ankara, Turkey, 06010
Sponsors and Collaborators
Sadiman Kiykac Altinbas
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Responsible Party: Sadiman Kiykac Altinbas, M. D., Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
ClinicalTrials.gov Identifier: NCT02020733    
Other Study ID Numbers: 20.12.13/160
First Posted: December 25, 2013    Key Record Dates
Last Update Posted: December 25, 2013
Last Verified: December 2013
Keywords provided by Sadiman Kiykac Altinbas, Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital:
Hysterosalpingography
balloon catheter
metal cannula
pain assessment