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

Sponsor
CMC Ambroise Paré (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05925400
Collaborator
(none)
340
Enrollment
1
Location
2
Arms
36
Anticipated Duration (Months)
9.4
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: Virtual Reality during Embryo Transfer
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
340 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Effect of Virtual Reality On IN-Vitro fEcuNdation ouTcomes: a Randomized Controlled Trial (VR-INVENT)
Anticipated Study Start Date :
Jul 25, 2023
Anticipated Primary Completion Date :
Jul 25, 2026
Anticipated Study Completion Date :
Jul 25, 2026

Arms and Interventions

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 5 minutes before the Embryo Transfer (ET) and a 10 min immersion after the ET

Outcome Measures

Primary Outcome Measures

  1. Clinical Pregnancy Rate [Assessed 4 weeks after embryo transfer]

    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

Secondary Outcome Measures

  1. State and Trait Anxiety Inventory (STAI) questionnaires [Questionnaires will be filled out in 2 different time points during the study: 1) ET day, 30 minutes before ET 2) ET day, 10 minutes after ET procedure]

    Therate of anxiety and stress level before and after embryo transfer, measured by the State and Trait Anxiety Inventory (STAI)

  2. Beck Depression Index (C-BDI-II) questionnaires [Questionnaires will be filled out in 2 different time points during the study: 1) ET day, 30 minutes before ET 2) ET day, 10 minutes after ET procedure]

    The rate of anxiety and stress level before and after embryo transfer, measured by Beck Depression Index (C-BDI-II) questionnaires

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 43 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinique Pierre Cherest Neuilly-sur-Seine France 92200

Sponsors and Collaborators

  • CMC Ambroise Paré

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CMC Ambroise Paré
ClinicalTrials.gov Identifier:
NCT05925400
Other Study ID Numbers:
  • 2022/02
First Posted:
Jun 29, 2023
Last Update Posted:
Jun 29, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by CMC Ambroise Paré
Virtual Reality
Embryo transfer
Pregnancy rate
Additional relevant MeSH terms:
Anxiety Disorders

Study Results

No Results Posted as of Jun 29, 2023