NCT05925400

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: CMC Ambroise Paré · Academic / Other
• Sex: Female
• Age: 18 Years – 43 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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 10-15 minutes before the Embryo Transfer (ET) and a 10 min immersion after the ET

Timeline

• Start date: 2023-11-15
• Primary completion: 2025-07-16
• Completion: 2025-07-16
• First posted: 2023-06-29
• Last updated: 2025-08-03

Locations

1 site across 1 country: France