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

Anxiety Clinical Trial

— VR-INVENT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05925400
• Other study ID #: 2022/02
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: January 15, 2027

Study information

• Verified date: January 2024
• Source: CMC Ambroise Paré
• Contact: Lee NGUYEN, MD
• Phone: 01 73 06 02 00
• Email: lee.nguyen[@]clinique-a-pare.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 340
• Est. completion date: January 15, 2027
• Est. primary completion date: November 15, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• IVF
• Stress

Intervention

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

Locations

Country	Name	City	State
France	Clinique Pierre Cherest	Neuilly-sur-Seine

Sponsors (1)

Lead Sponsor	Collaborator
CMC Ambroise Paré

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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