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Comparison Between Two Different Distention Medium in Diagnostic Hysteroscopy

NCT ID: NCT02958722

Last Updated: 2017-10-06

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

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-04-30

Brief Summary

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The investigators aim to enroll 2000 patients to undergo diagnostic hysteroscopy for suspected uterine pathologies. Women will be randomized into two groups on the basis of distension medium : group A CO2; group B physiological solution. Pain discomfort will be evaluated after the examination.

Detailed Description

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Conditions

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Hysteroscopy, Distension Medium, Pain

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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carbon dioxide

Diagnostic hysteroscopy performed with the carbon dioxide (gas)

Group Type ACTIVE_COMPARATOR

diagnostic hysteroscopy

Intervention Type PROCEDURE

Endoscopic procedure to visualize uterine cavity

carbon dioxide

Intervention Type DRUG

physiological solution

Diagnostic hysteroscopy performed with liquid solution (physiologic solution)

Group Type ACTIVE_COMPARATOR

diagnostic hysteroscopy

Intervention Type PROCEDURE

Endoscopic procedure to visualize uterine cavity

physiological solution

Intervention Type DRUG

Interventions

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diagnostic hysteroscopy

Endoscopic procedure to visualize uterine cavity

Intervention Type PROCEDURE

physiological solution

Intervention Type DRUG

carbon dioxide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* suspected uterine pathologies
* infertility

Exclusion Criteria

* pregnancy
* severe hypertension, cardiovascular disease or respiratory disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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ISC2

Identifier Type: -

Identifier Source: org_study_id