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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2027-02-01

Brief Summary

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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.

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Detailed Description

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This is a prospective, single-center, randomized, controlled interventional study that will include 72 patients. Patients will be randomized into two groups: a Control group, in which patients will receive conventional sedation (remifentanil 0.1 mcg/kg/min and propofol 0.5 mg/kg if necessary) during the retrieval, and an RVH 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. To be included, patients must have undergone egg retrieval as part of their IVF at the Cliniques universitaires Saint-Luc, be French-speaking, have undergone simple IVF or ICSI IVF, and must not be undergoing long-term psychotherapeutic treatment or taking psychotropic medications. They must also have given their free, informed and written consent signed by the investigator and the patient in the days preceding the intervention. Patients with morbid obesity, blindness and/or deafness and with a history contraindicating the use of anti-inflammatory drugs will be excluded from the study.

Conditions

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Oocyte Retrieval for IVF

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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control group

sedation with remifentanil and propofol

Group Type NO_INTERVENTION

No interventions assigned to this group

RVH group

RVH session + sedation with remifentanil and propofol

Group Type EXPERIMENTAL

virtual reality hypnosis device

Intervention Type 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.

Interventions

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virtual reality hypnosis device

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* egg retrieval as part of their IVF at the Cliniques universitaires Saint-Luc,
* to be French-speaking,
* simple IVF or ICSI IVF
* 18-42 yrs

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No