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

NCT05925400 | Terminated

• 1 other identifier: 2022/02
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

IVF; Stress; Anxiety

Keywords

Virtual Reality; Embryo transfer; Pregnancy rate

Outcome Measures

Primary Outcomes (1)

• Clinical Pregnancy Rate

  Clinical Pregnancy Rate defined by the presence of one or more gestational sacs with one or more embryos showing cardiac activity

  Assessed 12 weeks after embryo transfer

Secondary Outcomes (2)

• State and Trait Anxiety Inventory (STAI) questionnaires

  Questionnaires will be filled out in 2 different time points during the study: 1) ET day, 45 minutes before ET 2) ET day, 10 minutes after ET procedure

• Generalized Anxiety Disorder - 7 (GAD-7) questionnaires

  Questionnaires will be filled out in 2 different time points during the study: 1) ET day, 45 minutes before ET 2) ET day, 10 minutes after ET procedure

Study Arms (2)

ET without RV

NO INTERVENTION

Patients who will be randomized to the control group will wait for transfer of a fresh blastocyst on the 5th day of development OR a frozen embryo on the 5th day of development according to the usual service protocol.

ET with RV

EXPERIMENTAL

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

Interventions

Virtual Reality during Embryo Transfer DEVICE

Patients randomized to the study group, will be provided with the VR headset. The VR exposure will take place 10-15 minutes before the Embryo Transfer (ET) and a 10 min immersion after the ET

ET with RV

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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,
• Regular use of anxiolytics

Sponsors & Collaborators

• CMC Ambroise Paré: lead

Study Sites (1)

Clinique Pierre Cherest

Neuilly-sur-Seine, 92200, France

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: June 29, 2023
• Study Start: November 15, 2023
• Primary Completion: July 16, 2025
• Study Completion: July 16, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)