Oocyte Retrieval and Virtual Reality (REVPO)

NCT04935658 | Completed

• 2 other identifiers: AOI 2020 VALDEYRON2020-A03233-36
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oocyte Retrieval; Pain; Fertilization in Vitro

Keywords

Reproductive Techniques, Assisted; Oocyte retrieval; Virtual reality; Medically Assisted Procreation; Pain; Analgesia

Outcome Measures

Primary Outcomes (1)

• Pain during oocyte retrieval, assessed by NRS

  Oral evaluation of pain during the intervention for oocyte retrieval, evaluated by a Numeric Rating Scale (NRS) : from 0 (meaning no pain at all) to 10 (meaning worse pain possible).

  day 0 (During the intervention for oocyte retrieval)

Secondary Outcomes (5)

• Pain after oocyte retrieval, assessed by NRS

  hour 1 (In the hour following the oocyte retrival)

• Painkillers consumption during the 48 hours following the oocyte retrieval.

  Day 5

• Patient satisfaction concerning the use of virtual reality during the oocyte retrieval

  hour 1 (In the hour following the oocyte retrival)

• Gynaecologist satisfaction concerning the use of virtual reality during the oocyte retrieval

  hour 1 (In the hour following the oocyte retrival)

• Efficacy of the use of virtual reality during oocyte retrieval

  hour 1 (In the hour following the oocyte retrival)

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

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

Device: Hypnotic relaxation induced by virtual reality (device); Drug: local anesthesia

Standard Group

SHAM COMPARATOR

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

Drug: local anesthesia

Interventions

Hypnotic relaxation induced by virtual reality (device) 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.

Virtual Reality Group

local anesthesia DRUG

standard anesthesic procedure

Standard Group; Virtual Reality Group

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Former attempt of oocyte retrieval
• Poor oocyte stock : \> 40 years AND low markers (AMH \< 0.5-1.1 ng/ml OR AFC \< 5-7)
• Unsteady epilepsia

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Pain; Helping Behavior; Agnosia

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Camille Valdeyron

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: participants receive an intervention throughout the protocol

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: June 23, 2021
• Study Start: June 9, 2021
• Primary Completion: March 1, 2024
• Study Completion: July 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)