Interest of Virtual Reality in the Management of Anxiety and Pain During Embryo Transfer (ET) (VR-INVENT)

Effect of Virtual Reality On IN-Vitro fEcuNdation ouTcomes: a Randomized Controlled Trial (VR-INVENT)

This study compares the use of virtual Reality versus the usual service protocol for the management of anxiety and pain related to In-Vitro fertilization (IVF) procedure

Study Overview

• Status: Recruiting
• Conditions: Stress; Anxiety; IVF
• Intervention / Treatment: Device: Virtual Reality during Embryo Transfer

Detailed Description

Medical interventions that they often cause pain, distress or anxiety for most patients.

The use of music and movies has been shown to be effective in pediatrics.

Actually, Virtual Reality (VR) is a recent technology that allows the representation of a pleasant environment in three dimensions with a complete immersion by a helmet. By distracting patients, this technology can reduce anxiety, discomfort and ultimately pain associated with care.

This randomized monocentric trial compares the effect of the use of VR vs without VR during blastocyst transfer at day 5 on the pregnancy rate and the level of anxiety and stress of the patient.

Data on the level of anxiety and stress will be collected via quiz before and after the procedure. Also, pregnancy rate will be assessed 10 days after the procedure by β_HCG assessment.

• Study Type: Interventional
• Enrollment (Estimated): 340
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lee NGUYEN, MD; Phone Number: 01 73 06 02 00; Email: lee.nguyen@clinique-a-pare.fr

Study Locations

• France
  • Neuilly-sur-Seine, France, 92200
    • Recruiting
    • Clinique Pierre Cherest
    • Contact: Nadia KAZDAR, MD
    • Principal Investigator: Nadia KAZDAR, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Will benefit from in vitro Fertilization (IVF or ICSI)
• Aged over 18 and under 43,
• Attempt Rank 1 or 2
• To benefit from a transfer of a single fresh blastocyst on the 5th day of development
• Fresh embryo transfer
• Having received information and given their consent to participate in accordance with the regulations
• Benefiting from a social security scheme or entitled.

Exclusion Criteria:

• Use of frozen sperm
• Use of testicular sperm
• Fecundation technique used: IMSI
• Early embryo transfer on D2 or D3
• Inability to understand the information given
• Under guardianship, under curatorship or under safeguard of justice,
• Communication difficulties or neuropsychic disorders,
• Current corneal or conjunctival pathologies,
• Claustrophobia,
• Appearance of nausea in the mountains or at sea,
• Taking an anxiolytic or a sleeping pill within 12 hours prior to randomization

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: ET on D5 without RV; Patients who will be randomized to the control group will be waiting for the embryo transfer procedure according to the usual service protocol.
Experimental: ET on D5 with RV; The transfer and preparation in the transfer room will be done according to the usual service protocol. Exposure to virtual reality environment exposure	Device: Virtual Reality during Embryo Transfer; Patients randomized to the study group, will be provided with the VR headset. The VR exposure will take place 30 minutes before the Embryo Transfer (ET) and a 10 min immersion after the ET

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Pregnancy Rate	The rate of pregnancy , defined by a plasma beta-HCG dosage greater than 1000 UI , 10 days after the transfer, and sonographic evidence of a gestational sac on the echography of 6 weeks	Assessed 4 weeks after embryo transfer

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
State and Trait Anxiety Inventory (STAI) questionnaires	The rate of anxiety and stress level before and after embryo transfer, measured by the State and Trait Anxiety Inventory (STAI) StAI-Y1-State ranging from 20 to 80 (20 = Low Level of Anxiety), 80 = High Level Of Anxiety) StAI-Y2-Trait ranging from 20 to 80 (20 = Low Level of Anxiety), 80 = High Level Of Anxiety)	Questionnaires will be filled out in 2 different time points during the study: 1) ET day, 60 minutes before ET 2) ET day, 10 minutes after ET procedure
Beck Depression Index (C-BDI-II) questionnaires	The rate of anxiety and stress level before and after embryo transfer, measured by Beck Depression Index (C-BDI-II) questionnaires BDI-II ranging from 0 to 63 (0= No or Minimal Stress, 63= Worst Possible Stress)	Questionnaires will be filled out in 2 different time points during the study: 1) ET day, 60 minutes before ET 2) ET day, 10 minutes after ET procedure

Collaborators and Investigators

• Sponsor: CMC Ambroise Paré

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): January 15, 2027

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: June 21, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Virtual Reality; Embryo transfer; Pregnancy rate
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2022/02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No