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

Not Applicable

• Conditions: Anxiety; Virtual Reality; in Vitro Fertilization
• Interventions: Device: Virtual reality

• Registration Number: NCT03064061
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-26
• Study Start: 2017-02-17
• Study First Submitted QC: 2017-02-21
• Study First Posted: 2017-02-24
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-20
• Last Update Posted: 2018-03-22
• Primary Completion: 2019-03
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual reality Anxiety	Virtual reality	VR session with the goal of reducing anxiety before oocytes retrieval
Virtual Reality Neutral	Virtual reality	neutral VR session before oocytes retrieval

Primary Outcome Measures

Name	Time	Method
impact of the virtual reality on the pregnancy rate (Ultrasound)	12 weeks	measured by ultrasound

Secondary Outcome Measures

Name	Time	Method
state-trait Anxiety Inventory	immediate	measured with STAI Y-A Spielberger before and after the VR and when leaving the hospital
impact of the virtual reality on satisfaction	immediate	measured by a numeric scale 0-10
impact of the virtual reality on pregnancy test	6 weeks	measured by blood beta HCG level
impact of the virtual reality on anxiety (numeric scale)	immediate	measured with numeric scale (0-10) before and after the VR

Trial Locations

Locations (1)

Cliniques universitaires Saint-luc; 🇧🇪 Brussels, Belgium