Clinical Efficacy of Virtual Reality During Office Hysteroscopy and Endometrial Biopsy in Subfertility

NCT ID: NCT04438759

Last Updated: 2022-07-11

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

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-10

Study Completion Date

2021-12-31

Brief Summary

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This study is a comparison between the current standard practice of performing a diagnostic hysteroscopy and a relatively recently developed technology that is added to the standard diagnostic hysteroscopy. The aim of the study is to find out whether this newer technology has an advantage for the patient, in the form of anxiety and pain reduction.

Detailed Description

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Conditions

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Infertility, Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

This study is a comparison between the current standard practice of performing a diagnostic hysteroscopy and a relatively recently developed technology that is added to the standard diagnostic hysteroscopy. The aim of the study is to find out whether this newer technology has an advantage for the patient, in the form of anxiety and pain reduction.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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investigational group

Virtual Reality

Group Type EXPERIMENTAL

Oncomfort, commercially available Virtual Reality headset

Intervention Type DEVICE

Virtual Reality headset, consisting of headphones with smartphone glasses - see oncomfort.com/en, CE approval conform 93/42/EEC and 2007/47/EEC

reference group

standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Oncomfort, commercially available Virtual Reality headset

Virtual Reality headset, consisting of headphones with smartphone glasses - see oncomfort.com/en, CE approval conform 93/42/EEC and 2007/47/EEC

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* undergoing fertility treatments
* for which outpatient hysteroscopy has been prescribed
* for different possible indications: suspicion of intracavitary pathology, recurrent implantation failure, recurrent early pregnancy loss, …

Exclusion Criteria

1. Hearing impairments and blindness
2. Motion sickness
3. Any known anatomical characteristics that may make performing the office procedure impossible.
4. The unwillingness of the patient to undergo an office hysteroscopy
5. Denial or withdrawal of informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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valerie schutyser

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Locations

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UZ Brussel CRG

Jette, Brussels Capital, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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HYSVIR

Identifier Type: -

Identifier Source: org_study_id

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