Oocyte Retrieval and Virtual Reality (REVPO)

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-09

Study Completion Date

2024-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of the study is to ass wether or not the use of virtual reality during oocyte retrieval provides a better pain relief for patients, compared to a standard analgesic procedure.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Assessment of the Influence of the Virtual Reality Headset on Pain and Anxiety During Oocyte Retrieval Under Local Anesthesia

NCT05528497

Oocyte Retrieval Local Anaesthesia Virtual Reality

UNKNOWN NA

The Use of Virtual Reality Technology During Oocyte Retrieval for in Vitro Fertilization

NCT06733701

Oocyte Retrieval Adverse Events Procedural Anxiety +3 more

NOT_YET_RECRUITING NA

OPU-LUX: Virtual Reality for Pain and Anxiety Management During Oocyte Pick-up

NCT05830513

Pain, Postoperative IVF

UNKNOWN NA

Interest of Hypnosis in Virtual Reality on Nociception During Oocyte Retrieval in a Medically Assisted Reproduction Procedure

NCT05567315

Oocyte Retrieval

COMPLETED NA

Monocentric Randomised Controlled Trial to Assess Whether Virtual Reality Reduces the Use of Hypnotic Agents During IVF/ICSI Oocyte Retrieval

NCT07190729

Medically Assisted Procreation (MAP) Oocyte Retrieval

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients will be included during the consultation with the gynaecologist, whom will explain the protocol to the patient and give her the consent to sign.

The patient will be then randomized by a computer (using the software REDCAP) into either the experimental group or the standard group.

In the experimental group, a virtual reality device will be installed on the patient as soon as she arrives in the operating room, and the intervention will start after 3-5 minutes.

In both group, the patient will benefit of a local anesthesia in the vagina, and if they want it of an oral analgesic before the intervention.

Just at the end of the intervention, the pain will be evaluated orally by the nurse, using a Numeric Rating Scale. This consist of the Primary Outcome.

After the intervention, the gynaecologist will fill a form assessing his satisfaction concerning the use of virtual reality during the intervention (efficacy, security...) One hour after the intervention, the patient will fill a form about her self-estimation of the post-procedural pain and her satisfaction concerning the use of virtual reality.

The number of oocytes collected and the number of oocytes expected on the ultrasound monitoring will be gathered and a ratio will be calculated, in order to estimate the efficacy of the retrieval.

Five days after the intervention, the patient will have to fill a form evaluating her consumption of painkillers during the 48hours following the intervention.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oocyte Retrieval Pain Fertilization in Vitro

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

participants receive an intervention throughout the protocol

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Virtual Reality Group

in this group, patients will use virtual reality during the oocyte retrieval plus the standard anesthesic procedure (local anesthesia)

Group Type EXPERIMENTAL

Hypnotic relaxation induced by virtual reality (device)

Intervention Type DEVICE

A virtual reality device will be install on the patient 3-5 minutes before the beginning of the oocyte retrieval. The device will be wearing by the patient during the entire intervention and 2 minutes after the end of the ponction.

local anesthesia

Intervention Type DRUG

standard anesthesic procedure

Standard Group

in this group, patients will receive the standard anesthesic procedure during the oocyte retrieval wich is local anesthesia

Group Type SHAM_COMPARATOR

local anesthesia

Intervention Type DRUG

standard anesthesic procedure

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hypnotic relaxation induced by virtual reality (device)

A virtual reality device will be install on the patient 3-5 minutes before the beginning of the oocyte retrieval. The device will be wearing by the patient during the entire intervention and 2 minutes after the end of the ponction.

Intervention Type DEVICE

local anesthesia

standard anesthesic procedure

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Aged between 18 and 43 years
* First attempt of oocyte retrieval under local anesthesia in the context of a protocol for Medically Assisted Procreation