Oocyte RetrievalREVPONCT04935658
Oocyte Retrieval and Virtual Reality (REVPO)
A study testing Hypnotic relaxation induced by virtual reality (device) and local anesthesia in people with Oocyte Retrieval and Pain, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Oocyte Retrieval, Pain, Fertilization in Vitro
- What is being tested?
- Hypnotic relaxation induced by virtual reality (device) and local anesthesia
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jun 2021to 1 Jul 2024
- 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
- Aged between 18 and 43 years
- First attempt of oocyte retrieval under local anesthesia in the context of a protocol for Medically Assisted Procreation
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Study of Analgesic Effect of Virtual Reality During Oocyte Retrieval in in Vitro Fecondation Protocols: Controlled Randomized Trial
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.
Read the 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.
- Conditions
- Oocyte Retrieval, Pain, Fertilization in Vitro
- Being tested
- Hypnotic relaxation induced by virtual reality (device), local anesthesia
- Keywords
- Reproductive Techniques, Assisted, Oocyte retrieval, Virtual reality, Medically Assisted Procreation, Pain, Analgesia
- Medical subject headings
- Pain, Helping Behavior, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 anesthesiaDrug
standard anesthesic procedure
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | in this group, patients will use virtual reality during the oocyte retrieval plus the standard anesthesic procedure (local anesthesia) Receives: Device: Hypnotic relaxation induced by virtual reality (device); Drug: local anesthesia |
| Standard Group | Sham comparator | in this group, patients will receive the standard anesthesic procedure during the oocyte retrieval wich is local anesthesia Receives: Drug: local anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during oocyte retrieval, assessed by NRS
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).
Measured: day 0 (During the intervention for oocyte retrieval)
Secondary outcomes (5)
Pain after oocyte retrieval, assessed by NRS
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).
Measured: hour 1 (In the hour following the oocyte retrival)
Painkillers consumption during the 48 hours following the oocyte retrieval.
Written auto-evaluation (questionnaire) of the amount and type of painkillers taken by the patient during the 48hours following the intervention
Measured: Day 5
Patient satisfaction concerning the use of virtual reality during the oocyte retrieval
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")
Measured: hour 1 (In the hour following the oocyte retrival)
Gynaecologist satisfaction concerning the use of virtual reality during the oocyte retrieval
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")
Measured: hour 1 (In the hour following the oocyte retrival)
Efficacy of the use of virtual reality during oocyte retrieval
Ratio between the number of oocytes collected during the retrieval compared to the number of oocytes expected on the ultrasound monitoring
Measured: hour 1 (In the hour following the oocyte retrival)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start9 Jun 2021
- Primary completion1 Mar 2024
- Study completion1 Jul 2024
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- participants receive an intervention throughout the protocol
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Camille Valdeyron, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935658
- Sponsor's protocol ID
- AOI 2020 VALDEYRON
- Other IDs
- 2020-A03233-36
- Acronym
- REVPO
- Status last verified
- Sep 2024
- First submitted
- 25 May 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Analgesic Effect of Virtual Reality During Oocyte Retrieval in in Vitro Fecondation Protocols: Controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT04935658
- Acronym / sponsor ID
- REVPO / AOI 2020 VALDEYRON
- Conditions
- Oocyte Retrieval, Pain, Fertilization in Vitro
- Keywords
- Reproductive Techniques, Assisted, Oocyte retrieval, Virtual reality, Medically Assisted Procreation, Pain, Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 23 Jun 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- participants receive an intervention throughout the protocol
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Device: Hypnotic relaxation induced by virtual reality (device), Drug: local anesthesiain this group, patients will use virtual reality during the oocyte retrieval plus the standard anesthesic procedure (local anesthesia) |
| Standard Group | Sham comparator | Drug: local anesthesiain this group, patients will receive the standard anesthesic procedure during the oocyte retrieval wich is local anesthesia |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged between 18 and 43 years
- First attempt of oocyte retrieval under local anesthesia in the context of a protocol for Medically Assisted Procreation
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Hypnotic relaxation induced by virtual reality (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. | Device | Virtual Reality Group |
| local anesthesiastandard anesthesic procedure | Drug | Standard Group, Virtual Reality Group |
Primary outcome
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).
5 secondary outcomes
Pain after oocyte retrieval, assessed by NRS
Time frame: hour 1 (In the hour following the oocyte retrival)
Painkillers consumption during the 48 hours following the oocyte retrieval.
Time frame: Day 5
Patient satisfaction concerning the use of virtual reality during the oocyte retrieval
Time frame: hour 1 (In the hour following the oocyte retrival)
Gynaecologist satisfaction concerning the use of virtual reality during the oocyte retrieval
Time frame: hour 1 (In the hour following the oocyte retrival)
Efficacy of the use of virtual reality during oocyte retrieval
Time frame: hour 1 (In the hour following the oocyte retrival)
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 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Oocyte Retrieval
Not yet recruitingObservational study
Music Therapy and Sedation for Pain and Anxiety During Oocyte Retrieval
ANXIETY
RecruitingObservational study
Follicular Flushing Versus Direct Aspiration in Transabdominal Oocyte Retrieval
Fertility Preservation
Recruiting
Hormone-free Antral Retrieval for Viable Embryo Storage & Transfer
Infertility
Active, not recruitingPhase 4
Predictors of Postoperative Pain Following Oocyte Retrieval for Assisted Reproduction
Oocyte Retrieval, Postoperative Pain
Not yet recruitingPhase 4
Exogenous Progesterone as Ovulation Trigger
Ovulation, Ovarian Function
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.
Camille Valdeyron principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnotic relaxation induced by virtual reality (device) and local anesthesia in people with Oocyte Retrieval and Pain, run by University Hospital, Clermont-Ferrand 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 2 inclusion and 3 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 19 Sep 2024. 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. Some participants in this study may receive a placebo. 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, assessed by NRS (time frame: day 0 (During the intervention for oocyte retrieval)). 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 19 Sep 2024.