Clinical trial NCT04935658: Oocyte Retrieval and Virtual Reality (REVPO)
Official title: Study of Analgesic Effect of Virtual Reality During Oocyte Retrieval in in Vitro Fecondation Protocols: Controlled Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oocyte Retrieval
Pain
Fertilization in Vitro
Keywords: Reproductive Techniques, Assisted
Oocyte retrieval
Virtual reality
Medically Assisted Procreation
Pain
Analgesia
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: participants receive an intervention throughout the protocol
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain during oocyte retrieval, assessed by NRS
timeFrame: day 0 (During the intervention for oocyte retrieval)
Secondary outcomes:
measure: Pain after oocyte retrieval, assessed by NRS
timeFrame: hour 1 (In the hour following the oocyte retrival)
measure: Painkillers consumption during the 48 hours following the oocyte retrieval.
timeFrame: Day 5
measure: Patient satisfaction concerning the use of virtual reality during the oocyte retrieval
timeFrame: hour 1 (In the hour following the oocyte retrival)
measure: Gynaecologist satisfaction concerning the use of virtual reality during the oocyte retrieval
timeFrame: hour 1 (In the hour following the oocyte retrival)
measure: Efficacy of the use of virtual reality during oocyte retrieval
timeFrame: hour 1 (In the hour following the oocyte retrival)
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Camille Valdeyron
role: PRINCIPAL_INVESTIGATOR
References: