NCT02020733

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 25, 2013

Completed
Last Updated

December 25, 2013

Status Verified

December 1, 2013

Enrollment Period

8 months

First QC Date

December 19, 2013

Last Update Submit

December 24, 2013

Conditions

Pain During Hysterosalpingography

Keywords

Hysterosalpingographyballoon cathetermetal cannulapain assessment

Outcome Measures

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.

    1 hour after the procedure

Study Arms (2)

balloon catheter

OTHER
Device: Balloon catheter

metal cannula

OTHER
Device: metal cannula

Interventions

Balloon catheterDEVICE
balloon catheter
metal cannulaDEVICE
metal cannula

Eligibility Criteria

Age18 Years - 47 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Etlik Zubeyde Hanim Women's Health Teaching and Research Hospital

Ankara, 06010, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M. D.

Study Record Dates

First Submitted

December 19, 2013

First Posted

December 25, 2013

Study Start

June 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

December 25, 2013

Record last verified: 2013-12

Locations

TU(1)