NCT03064061

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

February 17, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 24, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

2 years

First QC Date

December 26, 2016

Last Update Submit

March 20, 2018

Conditions

Anxietyin Vitro FertilizationVirtual Reality

Outcome Measures

Primary Outcomes (1)

  • impact of the virtual reality on the pregnancy rate (Ultrasound)

    measured by ultrasound

    12 weeks

Secondary Outcomes (4)

  • impact of the virtual reality on anxiety (numeric scale)

    immediate

  • impact of the virtual reality on satisfaction

    immediate

  • impact of the virtual reality on pregnancy test

    6 weeks

  • state-trait Anxiety Inventory

    immediate

Study Arms (2)

Virtual Reality Neutral

SHAM COMPARATOR

neutral VR session before oocytes retrieval

Device: Virtual reality

Virtual reality Anxiety

ACTIVE COMPARATOR

VR session with the goal of reducing anxiety before oocytes retrieval

Device: Virtual reality

Interventions

Virtual realityDEVICE

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

Virtual Reality NeutralVirtual reality Anxiety

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Patients with long-term psychotherapeutic treatment
  • Patients taking psychotropic drugs
  • patient blind and deaf

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires Saint-luc

Brussels, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 26, 2016

First Posted

February 24, 2017

Study Start

February 17, 2017

Primary Completion

March 1, 2019

Study Completion

June 30, 2019

Last Updated

March 22, 2018

Record last verified: 2018-03

Locations

BE(1)