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

NCT ID: NCT02020733

Last Updated: 2013-12-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-02-28

Brief Summary

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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

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Conditions

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Pain During Hysterosalpingography

Keywords

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Hysterosalpingography balloon catheter metal cannula pain assessment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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balloon catheter

Group Type OTHER

Balloon catheter

Intervention Type DEVICE

metal cannula

Group Type OTHER

metal cannula

Intervention Type DEVICE

Interventions

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Balloon catheter

Intervention Type DEVICE

metal cannula

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

47 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sadiman Kiykac Altinbas

OTHER

Sponsor Role lead

Responsible Party

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Sadiman Kiykac Altinbas

M. D.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Etlik Zubeyde Hanim Women's Health Teaching and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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20.12.13/160

Identifier Type: -

Identifier Source: org_study_id