Evaluation of Pain During Hysterosalpingography With The... | NCT02020733

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

NCT02020733

Sponsor

Sadiman Kiykac Altinbas

Status

Completed

Last Update Posted

Dec 25, 2013Estimated

Enrollment

194Actual

Phase

Not Applicable

Conditions

Pain During Hysterosalpingography

Interventions

Balloon catheter
metal cannula

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Feb 2013Actual

Completion Date

Feb 2013Actual

First Submitted Date

Dec 19, 2013

First Submission Date that Met QC Criteria

Dec 24, 2013

First Posted Date

Dec 25, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 24, 2013

Last Update Posted Date

Dec 25, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sadiman Kiykac Altinbas, M. D., Etlik Zubeyde Hanim Womens' Health and Teaching HospitalSponsor-Investigator

Lead Sponsor

Sadiman Kiykac AltinbasOTHER

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

194Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
balloon catheter	Other		Device: Balloon catheter
metal cannula	Other		Device: metal cannula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Balloon catheter	Device		balloon catheter
metal cannula

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

47 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Etlik Zubeyde Hanim Women's Health Teaching and Research Hospital		Ankara		06010	Turkey (Türkiye)