Skip to main content
OpenTrials
Completed

NCT Number: NCT04935658

Oocyte Retrieval and Virtual Reality (REVPO)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Oocyte Retrieval Agnosia Behavior Fertilization in Vitro Helping Behavior Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Social Behavior

Age range

18 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Local anesthesia

Drug

standard anesthesic procedure

Primary outcomes

  1. Pain during oocyte retrieval, assessed by NRS

    Time frame: day 0 (During the intervention for oocyte retrieval)

    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).

Secondary outcomes

  1. Pain after oocyte retrieval, assessed by NRS

    Time frame: hour 1 (In the hour following the oocyte retrival)

    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).

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

    Time frame: Day 5

    Written auto-evaluation (questionnaire) of the amount and type of painkillers taken by the patient during the 48hours following the intervention

  3. Patient satisfaction concerning the use of virtual reality during the oocyte retrieval

    Time frame: hour 1 (In the hour following the oocyte retrival)

    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")

  4. Gynaecologist satisfaction concerning the use of virtual reality during the oocyte retrieval

    Time frame: hour 1 (In the hour following the oocyte retrival)

    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")

  5. Efficacy of the use of virtual reality during oocyte retrieval

    Time frame: hour 1 (In the hour following the oocyte retrival)

    Ratio between the number of oocytes collected during the retrieval compared to the number of oocytes expected on the ultrasound monitoring

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: REVPO

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 23, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.