Oocyte RetrievalOVOREVNCT05528497
Assessment of the Influence of the Virtual Reality Headset on Pain and Anxiety During Oocyte Retrieval Under Local Anesthesia
A study testing VR+ in people with Oocyte Retrieval and Local Anaesthesia, run by Rennes University Hospital at 1 site in France.
Trial summary
Medically Assisted Reproduction provides help to infertile couples, single women and couples of women with a pregnancy project, and to women who wish to preserve their gametes. In the context of In Vitro Fertilization (IVF), oocyte donation or oocyte preservation, it is necessary to perform an oocyte stimulation… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Oocyte Retrieval, Local Anaesthesia, Virtual Reality
- What is being tested?
- VR+
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 26 Sep 2022to 31 Aug 2023
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female adult (at least 18 years old)
- For whom an oocyte retrieval is planned
- Who has had an anesthesia consultation
- Who has chosen local anesthesia
- Who has signed an informed and written consent
- Affiliated to a social security system.
Who cannot join
- Pre-existing dizzying sensations
- Severe facial wounds
- History of epilepsy
- Adults under legal protection, curatorship or guardianship, adults deprived of liberty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Influence of the Virtual Reality Headset on Pain and Anxiety During Oocyte Retrieval Under Local Anesthesia (OVOREV)
Medically Assisted Reproduction provides help to infertile couples, single women and couples of women with a pregnancy project, and to women who wish to preserve their gametes. In the context of In Vitro Fertilization (IVF), oocyte donation or oocyte preservation, it is necessary to perform an oocyte stimulation, followed by an ovarian puncture in order to retrieve mature oocytes. Several types of anesthesia can be used for this procedure: general anesthesia, local anesthesia and spinal anesthesia. The puncture can also be performed under hypnosis, but this practice is difficult to generalize, as it requires specific training. None of these different types of anesthesia has proven to be superior in terms of number and quality of oocytes collected, so the choice is left to the patient. General anesthesia is mostly chosen at Rennes, although it exposes to more risks and represents a higher socio-economic cost.
Improving the comfort of these patients during oocyte retrieval is a priority, especially since they may have to undergo several successive retrievals during their treatment. What if virtual reality could be a way to improve the comfort of these patients? Indeed, this technology, which allows activity in an artificial 3-dimensional world, is considered as a non-pharmacological tool for pain management and its use during surgery would also reduce the level of anxiety. In our study, during the oocyte retrieval under local anesthesia, the patients randomized in the experimental group will wear a virtual reality headset diffusing an atmosphere considered as relaxing. The expected results of this work would be a significant decrease in pain during oocyte retrieval under local anesthesia in patients wearing the virtual reality headset, associated with a decrease of anxiety and a significantly higher satisfaction score. The final objective would be to consider this tool as a non-invasive means that could be used in routine in the department of Medically Assisted Reproduction of Rennes, but also in other cities. In the longer term, the reduction of pain and anxiety could encourage patients to choose local anesthesia and therefore increase its use.
Observational, prospective, randomized, open-label, monocentric study.
- Conditions
- Oocyte Retrieval, Local Anaesthesia, Virtual Reality
- Being tested
- VR+
- Keywords
- Oocyte Retrieval, Local anaesthesia, Virtual reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR+Other
Use of a virtual reality helmet during ovocyte retrieval
| Study group | Role | What they receive |
|---|---|---|
| VR+ | Experimental | For patients in the experimental group, using the virtual reality headset, the caregiver will place the headset on the patient as she is laid on the surgical table. The caregiver will ensure that the patient can see and hear the sequence that is being performed. The caregiver can then proceed to the different stages of ovocyte retrieval. Once the procedure is finished, the caregiver tells the patient that she can remove the headset Receives: Other: VR+ |
| Control | No intervention | For patients in the control group, without a headset, the oocyte retrieval procedure will not be modified. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during oocyte retrieval
The assessment criteria used is the numerical pain scale from 0 to 10 (0 = no pain, 10 = extremely painful)
Measured: 30 minutes
Secondary outcomes (5)
Anxiety during oocyte retrieval
The assessment criteria used a numerical scale ranging from 0 to 10 (0 = no anxiety, 10 = extremely anxious).
Measured: 30 minutes
Immediate postoperative pain
The assessment criteria used is the numerical pain scale from 0 to 10 (0 = no pain, 10 = extremely painful)
Measured: 30 minutes
The pain felt by the patient during the oocyte retrieval, according to the gynecologist who did the retrieval
The assessment criteria used is the numerical pain scale from 0 to 10 (0 = no pain, 10 = extremely painful)
Measured: 30 minutes
immediate postoperative satisfaction
The assessment criteria used is the Likert scale ranging from 1 (Very dissatisfied) to 5 (Very satisfied)
Measured: 30 minutes
Use of a complementary sedation or a general anesthesia
This criteria will be filled in by the gynecologistby the gynecologist who performed the retrieval:
- Only local anesthesia
- Use of an additional sedation
- Switch to general anesthesia
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start26 Sep 2022
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oocyte RetrievalStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528497
- Sponsor's protocol ID
- 35RC22_8923_OVOREV
- Other IDs
- 2022-A01275-38
- Acronym
- OVOREV
- Status last verified
- Jun 2026
- First submitted
- 30 Aug 2022
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Influence of the Virtual Reality Headset on Pain and Anxiety During Oocyte Retrieval Under Local Anesthesia (OVOREV)
- ClinicalTrials.gov ID
- NCT05528497
- Acronym / sponsor ID
- OVOREV / 35RC22_8923_OVOREV
- Conditions
- Oocyte Retrieval, Local Anaesthesia, Virtual Reality
- Keywords
- Oocyte Retrieval, Local anaesthesia, Virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 6 Sep 2022 (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.
Medically Assisted Reproduction provides help to infertile couples, single women and couples of women with a pregnancy project, and to women who wish to preserve their gametes. In the context of In Vitro Fertilization (IVF), oocyte donation or oocyte preservation, it is necessary to perform an oocyte stimulation, followed by an ovarian puncture in order to retrieve mature oocytes. Several types of anesthesia can be used for this procedure: general anesthesia, local anesthesia and spinal anesthesia. The puncture can also be performed under hypnosis, but this practice is difficult to generalize, as it requires specific training. None of these different types of anesthesia has proven to be superior in terms of number and quality of oocytes collected, so the choice is left to the patient. General anesthesia is mostly chosen at Rennes, although it exposes to more risks and represents a higher socio-economic cost.
Improving the comfort of these patients during oocyte retrieval is a priority, especially since they may have to undergo several successive retrievals during their treatment. What if virtual reality could be a way to improve the comfort of these patients? Indeed, this technology, which allows activity in an artificial 3-dimensional world, is considered as a non-pharmacological tool for pain management and its use during surgery would also reduce the level of anxiety. In our study, during the oocyte retrieval under local anesthesia, the patients randomized in the experimental group will wear a virtual reality headset diffusing an atmosphere considered as relaxing. The expected results of this work would be a significant decrease in pain during oocyte retrieval under local anesthesia in patients wearing the virtual reality headset, associated with a decrease of anxiety and a significantly higher satisfaction score. The final objective would be to consider this tool as a non-invasive means that could be used in routine in the department of Medically Assisted Reproduction of Rennes, but also in other cities. In the longer term, the reduction of pain and anxiety could encourage patients to choose local anesthesia and therefore increase its use.
Observational, prospective, randomized, open-label, monocentric study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR+ | Experimental | Other: VR+For patients in the experimental group, using the virtual reality headset, the caregiver will place the headset on the patient as she is laid on the surgical table. The caregiver will ensure that the patient can see and hear the sequence that is being performed. The caregiver can then proceed to the different stages of ovocyte retrieval. Once the procedure is finished, the caregiver tells the patient that she can remove the headset |
| Control | No intervention | –For patients in the control group, without a headset, the oocyte retrieval procedure will not be modified. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female adult (at least 18 years old)
- For whom an oocyte retrieval is planned
- Who has had an anesthesia consultation
- Who has chosen local anesthesia
- Who has signed an informed and written consent
Key exclusion criteria (4 listed)
- Pre-existing dizzying sensations
- Severe facial wounds
- History of epilepsy
- Adults under legal protection, curatorship or guardianship, adults deprived of liberty
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 |
|---|---|---|
| VR+Use of a virtual reality helmet during ovocyte retrieval | Other | VR+ |
Primary outcome
Pain during oocyte retrieval
Time frame: 30 minutes
The assessment criteria used is the numerical pain scale from 0 to 10 (0 = no pain, 10 = extremely painful)
5 secondary outcomes
Anxiety during oocyte retrieval
Time frame: 30 minutes
Immediate postoperative pain
Time frame: 30 minutes
The pain felt by the patient during the oocyte retrieval, according to the gynecologist who did the retrieval
Time frame: 30 minutes
immediate postoperative satisfaction
Time frame: 30 minutes
Use of a complementary sedation or a general anesthesia
Time frame: 30 minutes
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 17 Jun 2026.
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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 VR+ in people with Oocyte Retrieval and Local Anaesthesia, run by Rennes University Hospital 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 6 inclusion and 4 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 17 Jun 2026. 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?
Pain during oocyte retrieval (time frame: 30 minutes). 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 17 Jun 2026.