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

Primary Purpose

IVF, Stress, Anxiety

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Virtual Reality during Embryo Transfer
Sponsored by
CMC Ambroise Paré
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for IVF focused on measuring Virtual Reality, Embryo transfer, Pregnancy rate

Eligibility Criteria

18 Years - 43 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Clinique Pierre Cherest

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

ET on D5 without RV

ET on D5 with RV

Arm Description

Patients who will be randomized to the control group will be waiting for the embryo transfer procedure according to the usual service protocol.

The transfer and preparation in the transfer room will be done according to the usual service protocol. Exposure to virtual reality environment exposure

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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)

Full Information

First Posted
June 21, 2023
Last Updated
September 19, 2023
Sponsor
CMC Ambroise Paré
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1. Study Identification

Unique Protocol Identification Number
NCT05925400
Brief Title
Interest of Virtual Reality in the Management of Anxiety and Pain During Embryo Transfer (ET)
Acronym
VR-INVENT
Official Title
Effect of Virtual Reality On IN-Vitro fEcuNdation ouTcomes: a Randomized Controlled Trial (VR-INVENT)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 25, 2023 (Anticipated)
Primary Completion Date
October 25, 2026 (Anticipated)
Study Completion Date
October 25, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CMC Ambroise Paré

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IVF, Stress, Anxiety
Keywords
Virtual Reality, Embryo transfer, Pregnancy rate

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
340 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ET on D5 without RV
Arm Type
No Intervention
Arm Description
Patients who will be randomized to the control group will be waiting for the embryo transfer procedure according to the usual service protocol.
Arm Title
ET on D5 with RV
Arm Type
Experimental
Arm Description
The transfer and preparation in the transfer room will be done according to the usual service protocol. Exposure to virtual reality environment exposure
Intervention Type
Device
Intervention Name(s)
Virtual Reality during Embryo Transfer
Intervention Description
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
Primary Outcome Measure Information:
Title
Clinical Pregnancy Rate
Description
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
Time Frame
Assessed 4 weeks after embryo transfer
Secondary Outcome Measure Information:
Title
State and Trait Anxiety Inventory (STAI) questionnaires
Description
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)
Time Frame
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
Title
Beck Depression Index (C-BDI-II) questionnaires
Description
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)
Time Frame
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lee NGUYEN, MD
Phone
01 73 06 02 00
Email
lee.nguyen@clinique-a-pare.fr
Facility Information:
Facility Name
Clinique Pierre Cherest
City
Neuilly-sur-Seine
ZIP/Postal Code
92200
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadia KAZDAR, MD
First Name & Middle Initial & Last Name & Degree
Nadia KAZDAR, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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