Using Virtual Reality to Manage Anxiety and Pain During Embryo Transfer
Effect of Virtual Reality On IN-Vitro fEcuNdation ouTcomes: a Randomized Controlled Trial (VR-INVENT)
This study is testing if using virtual reality can help reduce anxiety and pain during embryo transfers for people undergoing IVF, and see if it leads to better pregnancy outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 760 (estimated) |
| Ages | 18 Years to 43 Years |
| Sex | Female |
| Sponsor | CMC Ambroise Paré Academic / other |
| Locations | 1 site (Neuilly-sur-Seine) |
| Trial ID | NCT05925400 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of virtual reality (VR) against standard care in managing anxiety and pain during the embryo transfer process in in-vitro fertilization (IVF). Participants will be randomly assigned to either receive VR treatment or standard care while undergoing the transfer of a fresh or frozen embryo. The primary outcome will be the clinical pregnancy rate, while secondary outcomes will assess changes in anxiety and stress levels through questionnaires administered before and after the procedure. The goal is to determine if VR can enhance patient comfort and improve pregnancy outcomes.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 43 undergoing their first or second IVF attempt requiring a single embryo transfer.
Not a fit: Patients who have communication difficulties, neuropsychic disorders, or conditions such as claustrophobia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce anxiety and pain for patients undergoing embryo transfer, potentially leading to higher pregnancy rates.
How similar studies have performed: Other studies have shown positive outcomes using virtual reality for pain and anxiety management in various medical procedures, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Neuilly-sur-Seine
- Clinique Pierre Cherest — Neuilly-sur-Seine, France (Recruiting)
Study contacts
- Study coordinator: Lee NGUYEN, MD
- Email: lee.nguyen@clinique-a-pare.fr
- Phone: 01 73 06 02 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.