Oocyte Retrieval and Virtual Reality (REVPO) (REVPO)

Study of Analgesic Effect of Virtual Reality During Oocyte Retrieval in In Vitro Fecondation Protocols: Controlled Randomized Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Oocyte Retrieval; Fertilization in Vitro
• Intervention / Treatment: Device: Hypnotic relaxation induced by virtual reality (device); Drug: local anesthesia

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: LISE LACLAUTRE; Phone Number: +33473754963; Email: promo_interne_drci@chu-clermontferrand.fr

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • Recruiting
    • CHU de Clermont-Ferrand
    • Sub-Investigator: Florence Brugnon
    • Principal Investigator: Camille Valdeyron
    • Contact: LISE LACLAUTRE; Phone Number: +33473754963; Email: promo_interne_drci@chu-clermontferrand.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 43 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Group; 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); 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.; Drug: local anesthesia; standard anesthesic procedure
Sham Comparator: Standard Group; in this group, patients will receive the standard anesthesic procedure during the oocyte retrieval wich is local anesthesia	Drug: local anesthesia; standard anesthesic procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain after oocyte retrieval, assessed by NRS	Written evaluation of pain after 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).	hour 1 (In the hour following the oocyte retrival)
Painkillers consumption during the 48 hours following the oocyte retrieval.	Written auto-evaluation (questionnaire) of the amount and type of painkillers taken by the patient during the 48hours following the intervention	Day 5
Patient satisfaction concerning the use of virtual reality during the oocyte retrieval	Written evaluation of the patient global satisfaction concerning the virtual reality during the oocyte retrieval. (2 questions : "Concerning the use of virtual reality during the oocyte retrieval, are you : very satisfied, little satisfied, not satisfied, not at all satisfied"; "if you had to re-take an oocyte retrieval, would you : do it again with virtual reality, do it again without virtual reality, do it under general anesthesia")	hour 1 (In the hour following the oocyte retrival)
Gynaecologist satisfaction concerning the use of virtual reality during the oocyte retrieval	Written evaluation of the gynaecologist satisfaction concerning the use of virtual reality during the oocyte retrieval (4 questions : "Concerning the security during the oocyte retrieval, are you very satisfied, little satisfied, not satisfied, not at all satisfied", "Concerning the easiness of the oocyte retrieval, are you very satisfied, little satisfied, not satisfied, not at all satisfied", "During the oocyte retrieval, the patient seemed : very relaxed, relaxed, not relaxed, not at relaxed"; "as a whole, if this patient should re-take an oocyte retrieval, ould you recommend the use of virtual reality? Yes/No, can you tell us why in a few words")	hour 1 (In the hour following the oocyte retrival)
Efficacy of the use of virtual reality during oocyte retrieval	Ratio between the number of oocytes collected during the retrieval compared to the number of oocytes expected on the ultrasound monitoring	hour 1 (In the hour following the oocyte retrival)

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Camille Valdeyron, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 25, 2021
• First Submitted That Met QC Criteria: June 15, 2021
• First Posted (Actual): June 23, 2021

Study Record Updates

• Last Update Posted (Actual): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Analgesia; Virtual reality; Reproductive Techniques, Assisted; Oocyte retrieval; Medically Assisted Procreation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Hypnotics and Sedatives
• Other Study ID Numbers: AOI 2020 VALDEYRON; 2020-A03233-36 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No