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OpenTrials
Completed

NCT Number: NCT02020733

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

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.

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Key information

Conditions

Pain During Hysterosalpingography

Age range

18 year–47 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Etlik Zubeyde Hanim Women's Health Teaching and Research Hospital

Ankara, 06010, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

balloon catheter

Device

metal cannula

Device

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sadiman Kiykac Altinbas

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 25, 2013
Registry last updated
Dec 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.