Virtual Reality Hypnosis as Sedation During Oocyte Retrieval: Effect on Propofol Consumption

NCT07104409 | Not Yet Recruiting

• 2 other identifiers: 2025/24JUI/253VRH-IVF
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

An egg retrieval is performed during an IVF course. This painful procedure is performed using sedation to ensure patient comfort. A combination of sedative and analgesic medications combined with local anesthesia (paracervical block) is used. Propofol, the intravenous anesthetic of choice (rapid-acting and short-acting), and remifentanil (an ultra-short-acting opioid analgesic) are generally combined. The potential impact of these agents used for egg retrieval on egg fertilization and embryo quality is of interest. Indeed, certain drugs such as propofol could accumulate in the follicular fluid. The few studies conducted to date show contradictory results. While a harmful effect appears to be reported in experimental studies on mice, this effect is uncertain in clinical studies. Given this uncertainty, any method aimed at reducing propofol consumption in this context may be of interest. Virtual reality hypnosis (VRH) is a digital tool that has already been shown to be effective in reducing preoperative anxiety during oocyte retrieval. Furthermore, VRH has also demonstrated analgesic effects. The primary objective of this study is to compare VRH with a control group (usual sedation) on propofol consumption during oocyte retrieval. Secondary objectives are to compare preoperative anxiety, APAIS score, catastrophizing score, remifentanil consumption, intra- and/or post-operative nausea and vomiting, post-procedural analgesic consumption, time perception during the procedure, fertilization parameters, and pregnancy rate at 12 weeks. The degrees of absorption, dissociation, immersion, and presence for the VRH group will also be noted.

Conditions

Oocyte Retrieval for IVF

Keywords

virtual reality; hypnosis; oocyte retrieval

Outcome Measures

Primary Outcomes (1)

• The primary outcome of this study is to compare VRH with a control group (usual sedation) on propofol consumption during the procedure.

  Day 0

Study Arms (2)

control group

NO INTERVENTION

sedation with remifentanil and propofol

RVH group

EXPERIMENTAL

RVH session + sedation with remifentanil and propofol

Other: virtual reality hypnosis device

Interventions

virtual reality hypnosis device OTHER

VRH group, in which patients will receive conventional sedation (remifentanil 0.1 mcg/kg/min and propofol 0.5 mg/kg if necessary) and a Virtual Reality headset with an environment chosen by the patient and hypnosis support with suggestions to reduce their anxiety.

RVH group

Eligibility Criteria

• Age: 18 Years - 42 Years
• Gender Eligibility Details: only people who has oocyte retrieval for IVF
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• egg retrieval as part of their IVF at the Cliniques universitaires Saint-Luc,
• to be French-speaking,
• simple IVF or ICSI IVF
• yrs

You may not qualify if:

• morbid obesity
• blindness and/or deafness
• history contraindicating the use of anti-inflammatory drugs
• long-term psychotherapeutic treatment or taking psychotropic medications.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Related Publications (3)

• Rousseaux F, Panda R, Toussaint C, Bicego A, Niimi M, Faymonville ME, Nyssen AS, Laureys S, Gosseries O, Vanhaudenhuyse A. Virtual reality hypnosis in the management of pain: Self-reported and neurophysiological measures in healthy subjects. Eur J Pain. 2023 Jan;27(1):148-162. doi: 10.1002/ejp.2045. Epub 2022 Oct 24.

  PMID: 36196745 BACKGROUND

• Pirard C, Laurent P, Wyns C, Giudice MG, Watremez C, Momeni M, Roelants F. Impact of virtual reality with or without hypnosis before oocyte retrieval: A randomised study. Complement Ther Med. 2025 Mar;88:103125. doi: 10.1016/j.ctim.2024.103125. Epub 2025 Jan 3.

  PMID: 39756588 BACKGROUND

• Matsota P, Sidiropoulou T, Vrantza T, Boutsikou M, Midvighi E, Siristatidis C. Comparison of Two Different Sedation Protocols during Transvaginal Oocyte Retrieval: Effects on Propofol Consumption and IVF Outcome: A Prospective Cohort Study. J Clin Med. 2021 Mar 1;10(5):963. doi: 10.3390/jcm10050963.

  PMID: 33804575 BACKGROUND

Study Officials

• Fabienne Roelants, MD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabienne Roelants, MD

CONTACT

+3227641821; fabienne.roelants@saintluc.uclouvain.be

Céline Pirard, MD, PhD

CONTACT

+3227644115; celine.pirard@saintluc.uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: September 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share