Oocyte Retrieval and Virtual Reality (REVPO)

University Hospital, Clermont-Ferrand

Status: Completed

Conditions: Fertilization in Vitro; Oocyte Retrieval; Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04935658

2020-A03233-36 (Other Identifier)

AOI 2020 VALDEYRON

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Virtual Reality Group

Experimental group

Description:

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

Treatment:

Device: Hypnotic relaxation induced by virtual reality (device)

Drug: local anesthesia

Standard Group

Sham Comparator group

Description:

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

Treatment:

Drug: local anesthesia