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

NCT ID: NCT05925400

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-15
• Study Completion Date: 2025-07-16

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

Detailed Description

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

The use of music and movies has proven effective in pediatrics.

Virtual Reality (VR) is a newer technology that immerses users in a pleasant, three-dimensional environment via a headset. 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 versus without VR during the transfer of a fresh blastocyst on the 5th day of development OR a frozen embryo on the 5th day of development.

The primary outcome will include clinical pregnancy rate and the secondary outcome focuses on the patient's levels of anxiety and stress.

Data on the level of anxiety and stress will be collected through questionnaires before and after the procedure. Also, clinical pregnancy, defined by the presence of one or more gestational sacs with one or more embryos showing cardiac activity, will be assessed through ultrasons 8 ± 4 weeks after the procedure

Conditions

IVF; Stress; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

ET without RV

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

ET 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

Group Type: EXPERIMENTAL

Virtual Reality during Embryo Transfer

Intervention Type: 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

Interventions

Virtual Reality during Embryo Transfer

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

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,
• Regular use of anxiolytics

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

CMC Ambroise Paré

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique Pierre Cherest

Neuilly-sur-Seine, , France

Countries

France

Other Identifiers

2022/02

Identifier Type: -

Identifier Source: org_study_id