Impact of Virtual Reality Before Oocytes Retrieval on Anxiety and Pregnancy Rate

NCT ID: NCT03064061

Last Updated: 2018-03-22

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-17

Study Completion Date

2019-06-30

Brief Summary

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The primary objective of this study is to evaluate the impact of a session of virtual reality (VR) with the objective of lowering the anxiety level on the clinical pregnancy rate following an In-vitro fertilisation (IVF) procedure. Indeed, anxiety in relation to infertility happens frequently and over time, can become stressful for our patients. This level of stress influences the effect of the infertility treatment. Reducing anxiety levels could promote the ability of the patients to face this stress and promote a greater chance of pregnancy in that context.

Detailed Description

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Conditions

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Anxiety in Vitro Fertilization Virtual Reality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Virtual Reality Neutral

neutral VR session before oocytes retrieval

Group Type SHAM_COMPARATOR

Virtual reality

Intervention Type DEVICE

a device with virtual reality is given to the patients with a film of 18 minutes

Virtual reality Anxiety

VR session with the goal of reducing anxiety before oocytes retrieval

Group Type ACTIVE_COMPARATOR

Virtual reality

Intervention Type DEVICE

a device with virtual reality is given to the patients with a film of 18 minutes

Interventions

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Virtual reality

a device with virtual reality is given to the patients with a film of 18 minutes

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult patients benefiting from an oocytes retrieval as part of their IVF at Cliniques universitaires Saint-Luc.
* Simple IVF / IVF Intracytoplasmic sperm injection (ICSI)

Exclusion Criteria

* Patients with long-term psychotherapeutic treatment
* Patients taking psychotropic drugs
* patient blind and deaf
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Roelants

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cliniques universitaires Saint-luc

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Facility Contacts

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Fabienne Roelants, MD

Role: primary

+3227641821

Célilne Pirard, MD PhD

Role: backup

+3227644112

Other Identifiers

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2016/20JUL/346

Identifier Type: -

Identifier Source: org_study_id

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