Medically Assisted Procreation (MAP)REVAHPOVONCT07190729
Monocentric Randomised Controlled Trial to Assess Whether Virtual Reality Reduces the Use of Hypnotic Agents During IVF/ICSI Oocyte Retrieval
A study testing Propofol sedation + Audiovisual distraction and Propofol sedation in people with Medically Assisted Procreation (MAP) and Oocyte Retrieval, run by Groupe Hospitalier Diaconesses Croix Saint-Simon at 1 site in France.
Trial summary
Over the last few years, audiovisual distraction devices using animation, films and 3D immersion have been developed, with the aim to provide patients with a relaxing experience that disconnects them from the operating environment while still allowing them to interact with the surgeon. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Medically Assisted Procreation (MAP), Oocyte Retrieval
- What is being tested?
- Propofol sedation + Audiovisual distraction and Propofol sedation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 4 Apr 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Over 18 and under 43 years of age.
- Requiring propofol sedation for oocyte puncture.
- Who can be contacted directly by telephone the day after the procedure.
- Have given their consent to participate in accordance with the regulations.
- Benfeting of a social security scheme or entitled persons (excluding AME).
Who cannot join
- Active endometriosis.
- Presence of at least one anatomically high ovary which is difficult to puncture.
- Inability to understand the information provided.
- Under guardianship, curatorship or legal protection.
- Under psychiatric care.
- Admitted to a health or social establishment for purposes other than this research.
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- Under constraint or deprived of liberty by judicial or administrative decision.
- Impaired communication or neuropsychological disorders.
- Ongoing corneal or conjunctival pathologies.
- Claustrophobia.
- Nausea in the mountains or at sea.
- Use of an anxiolytic or sleeping pill in the 12 hours prior to randomisation.
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Diaconesses Croix Saint-Simon
Paris, PARIS, 75020
About this study
Over the last few years, audiovisual distraction devices using animation, films and 3D immersion have been developed, with the aim to provide patients with a relaxing experience that disconnects them from the operating environment while still allowing them to interact with the surgeon. These devices make it easier for surgeons to perform short procedures and improve patients' experiences.
Virtual distraction techniques have been evaluated in several areas, particularly in managing preoperative pain and anxiety in adults.
However, to date, no study comparing different techniques for focusing attention and the anaesthetic management of oocyte punctures has been published. Our study will evaluate if using the Deepsen™ mask device to focus attention in a virtual reality environment is more effective than the usual verbal reassurance technique at reducing anxiety levels and sedation requirements during oocyte punctures, while improving comfort and enabling faster walking.
Read the detailed description
Over the last few years, audiovisual distraction devices using animation, films and 3D immersion have been developed. These devices aim to provide patients with a relaxing experience that disconnects them from the operating environment while still allowing them to interact with the surgeon. These devices make it easier for surgeons to perform short procedures and improve patients' experiences.
Virtual distraction techniques have been evaluated in several areas, particularly in managing preoperative pain and anxiety in adults.
However, no study comparing different techniques for focusing attention and the anaesthetic management of oocyte punctures has been published to date. This study hypothesises that using the Deepsen™ mask device to focus attention in a virtual reality environment is more effective than the usual verbal reassurance technique at reducing anxiety levels and sedation requirements during oocyte punctures, while improving comfort and enabling faster walking.
- Being tested
- Propofol sedation + Audiovisual distraction, Propofol sedation
- Keywords
- Virtual reality, Propofol sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol sedation + Audiovisual distractionDevice
The participants will receive standard propofol sedation procedure and the mask -RV Deepsen™
Propofol sedationOther
The participants will receive standard propofol sedation procedure
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Active comparator | Control group: the participants will receive standard propofol sedation procedure Receives: Other: Propofol sedation |
| Experimental arm | Experimental | Experimental group: the participants will receive standard propofol sedation procedure and the mask -RV Deepsen™ Receives: Device: Propofol sedation + Audiovisual distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Cp50 value of propofol in each group.
The Cp50 is defined as the median of the target concentration at which 50% of participants showed movement during the oocyte puncture procedure. Any difference between the two groups will be determined using Dixon's up and down technique
Measured: Day 0
The number and proportion of participants not requiring sedation
Measured: Day 0
Secondary outcomes (9)
Effect on procedural anxiety
The participant's anxiety was measured prior to the study. It was assessed using the STAI questionnaire in order to define the general state of anxiety (STRAI) and the level of immediate anxiety in relation to the examination (STATE). This is a two-part questionnaire with around thirty questions in each section, for which a single response is used to describe the intensity of the relationship: very often, often, rarely, never. An anxiety VAS will be requested at the time of the WHO checklist, together with the intensity of any pain. These questions will be asked again in the intensive care unit when the patient is put in the standing position.
Measured: Day 0
Tolerating audiovisual distraction
Tolerance of the device and the audiovisual distraction session is defined by the occurrence of undesirable effects (dizziness, nausea, headaches). This is done using a 4-level scale for each item (none, mild, moderate, severe).
Measured: 48 hours
Pain on injection of propofol
The intensity of pain on propofol injection was assessed using a three-point behavioural scale for facial expression (0: none, 1: frown, or 2: grimace), verbal response (0: none, 1: groan, or 2: clear expression of pain) and attempt to withdraw the arm (0: none, 1: medium, or 2: strong). The discomfort scale is the sum of these three clinical parameters and therefore ranges from 0 to 6.
Measured: Day 0
Complications observed during anaesthesia
Any complications linked to anaesthesia from induction to recovery are collected:
- Number of events with arterial oxygen desaturation below 92%,
- Number of episodes with a ventilatory frequency of less than 10 cycles/min,
- Occurrence of bronchospasm.
Measured: Day 0
The time required to walk
Time to street readiness will be assessed using the CHUNG
Measured: Day 0
Acceptance of audiovisual distraction by anaesthetists, gynaecologists and other healthcare professionals
Acceptance of audiovisual distraction by anaesthetists, gynaecologists and nursers will be assessed using a 4-level scale (very satisfied, satisfied, partially satisfied, not satisfied) and by collecting reasons for not being satisfied (partially satisfied, not satisfied) (short open answers).
Measured: Day 0
Participant satisfaction with the procedure
Participant satisfaction is assessed on leaving the post-interventional monitoring room using a 4-level scale (very satisfied, satisfied, partially satisfied, not satisfied), with a free text provided in addition. Any interruption of the audiovisual distraction session at the participant's request will be noted. Satisfaction with the procedure may also be obtained from healthcare professionals.
Measured: Day 0
Resumption of activities of daily living
Resumption of activities of daily living was assessed during the next day's telephone call using a subjective numerical rating scale ranging from 0 (bedridden) to 10 (full recovery).
Measured: Day 1
Recovery room discharge time
Post-intervention monitoring room discharge time is defined as the time between the end of the operation and the achievement of an ALDRETE score of 10.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start4 Apr 2023
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medically Assisted Procreation (MAP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control group: standard propofol sedation procedure Experimental group: standard propofol sedation procedure + mask -RV Deepsen™
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-Simon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190729
- Sponsor's protocol ID
- 2022-A00311-42
- Acronym
- REVAHPOVO
- Status last verified
- Nov 2025
- First submitted
- 17 Sep 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric Randomised Controlled Trial to Assess Whether Virtual Reality Reduces the Use of Hypnotic Agents During IVF/ICSI Oocyte Retrieval
- ClinicalTrials.gov ID
- NCT07190729
- Acronym / sponsor ID
- REVAHPOVO / 2022-A00311-42
- Keywords
- Virtual reality, Propofol sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-SimonUniversity, hospital or other
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Over the last few years, audiovisual distraction devices using animation, films and 3D immersion have been developed, with the aim to provide patients with a relaxing experience that disconnects them from the operating environment while still allowing them to interact with the surgeon. These devices make it easier for surgeons to perform short procedures and improve patients' experiences.
Virtual distraction techniques have been evaluated in several areas, particularly in managing preoperative pain and anxiety in adults.
However, to date, no study comparing different techniques for focusing attention and the anaesthetic management of oocyte punctures has been published. Our study will evaluate if using the Deepsen™ mask device to focus attention in a virtual reality environment is more effective than the usual verbal reassurance technique at reducing anxiety levels and sedation requirements during oocyte punctures, while improving comfort and enabling faster walking.
Detailed description
Over the last few years, audiovisual distraction devices using animation, films and 3D immersion have been developed. These devices aim to provide patients with a relaxing experience that disconnects them from the operating environment while still allowing them to interact with the surgeon. These devices make it easier for surgeons to perform short procedures and improve patients' experiences.
Virtual distraction techniques have been evaluated in several areas, particularly in managing preoperative pain and anxiety in adults.
However, no study comparing different techniques for focusing attention and the anaesthetic management of oocyte punctures has been published to date. This study hypothesises that using the Deepsen™ mask device to focus attention in a virtual reality environment is more effective than the usual verbal reassurance technique at reducing anxiety levels and sedation requirements during oocyte punctures, while improving comfort and enabling faster walking.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Control group: standard propofol sedation procedure Experimental group: standard propofol sedation procedure + mask -RV Deepsen™
| Arm | Type | Receives |
|---|---|---|
| Control arm | Active comparator | Other: Propofol sedationControl group: the participants will receive standard propofol sedation procedure |
| Experimental arm | Experimental | Device: Propofol sedation + Audiovisual distractionExperimental group: the participants will receive standard propofol sedation procedure and the mask -RV Deepsen™ |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Over 18 and under 43 years of age.
- Requiring propofol sedation for oocyte puncture.
- Who can be contacted directly by telephone the day after the procedure.
- Have given their consent to participate in accordance with the regulations.
- Benfeting of a social security scheme or entitled persons (excluding AME).
Key exclusion criteria (12 listed)
- Active endometriosis.
- Presence of at least one anatomically high ovary which is difficult to puncture.
- Inability to understand the information provided.
- Under guardianship, curatorship or legal protection.
- Under psychiatric care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propofol sedation + Audiovisual distractionThe participants will receive standard propofol sedation procedure and the mask -RV Deepsen™ | Device | Experimental arm |
| Propofol sedationThe participants will receive standard propofol sedation procedure | Other | Control arm |
Primary outcome
The Cp50 value of propofol in each group.
Time frame: Day 0
The Cp50 is defined as the median of the target concentration at which 50% of participants showed movement during the oocyte puncture procedure. Any difference between the two groups will be determined using Dixon's up and down technique
The number and proportion of participants not requiring sedation
Time frame: Day 0
9 secondary outcomes
Effect on procedural anxiety
Time frame: Day 0
Tolerating audiovisual distraction
Time frame: 48 hours
Pain on injection of propofol
Time frame: Day 0
Complications observed during anaesthesia
Time frame: Day 0
The time required to walk
Time frame: Day 0
Acceptance of audiovisual distraction by anaesthetists, gynaecologists and other healthcare professionals
Time frame: Day 0
Participant satisfaction with the procedure
Time frame: Day 0
Resumption of activities of daily living
Time frame: Day 1
Recovery room discharge time
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol sedation + Audiovisual distraction and Propofol sedation in people with Medically Assisted Procreation (MAP) and Oocyte Retrieval, run by Groupe Hospitalier Diaconesses Croix Saint-Simon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Cp50 value of propofol in each group. (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.