Oocyte Retrieval for IVFVRH-IVFNCT07104409
Virtual Reality Hypnosis as Sedation During Oocyte Retrieval: Effect on Propofol Consumption
A study testing virtual reality hypnosis device in people with Oocyte Retrieval for IVF, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Trial summary
An egg retrieval is performed during an IVF course. This painful procedure is performed using sedation to ensure patient comfort. A combination of sedative and analgesic medications combined with local anesthesia (paracervical block) is used. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Oocyte Retrieval for IVF
- What is being tested?
- virtual reality hypnosis device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- egg retrieval as part of their IVF at the Cliniques universitaires Saint-Luc,
- to be French-speaking,
- simple IVF or ICSI IVF
- 18-42 yrs
Who cannot join
- morbid obesity
- blindness and/or deafness
- history contraindicating the use of anti-inflammatory drugs
- long-term psychotherapeutic treatment or taking psychotropic medications.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Virtual Reality Hypnosis as Sedation During Oocyte Retrieval: Effect on Propofol Consumption: a Randomized Study (VRH-IVF)
An egg retrieval is performed during an IVF course. This painful procedure is performed using sedation to ensure patient comfort. A combination of sedative and analgesic medications combined with local anesthesia (paracervical block) is used. Propofol, the intravenous anesthetic of choice (rapid-acting and short-acting), and remifentanil (an ultra-short-acting opioid analgesic) are generally combined. The potential impact of these agents used for egg retrieval on egg fertilization and embryo quality is of interest. Indeed, certain drugs such as propofol could accumulate in the follicular fluid. The few studies conducted to date show contradictory results. While a harmful effect appears to be reported in experimental studies on mice, this effect is uncertain in clinical studies. Given this uncertainty, any method aimed at reducing propofol consumption in this context may be of interest. Virtual reality hypnosis (VRH) is a digital tool that has already been shown to be effective in reducing preoperative anxiety during oocyte retrieval. Furthermore, VRH has also demonstrated analgesic effects.
The primary objective of this study is to compare VRH with a control group (usual sedation) on propofol consumption during oocyte retrieval.
Secondary objectives are to compare preoperative anxiety, APAIS score, catastrophizing score, remifentanil consumption, intra- and/or post-operative nausea and vomiting, post-procedural analgesic consumption, time perception during the procedure, fertilization parameters, and pregnancy rate at 12 weeks. The degrees of absorption, dissociation, immersion, and presence for the VRH group will also be noted.
Read the detailed description
This is a prospective, single-center, randomized, controlled interventional study that will include 72 patients. Patients will be randomized into two groups: a Control group, in which patients will receive conventional sedation (remifentanil 0.1 mcg/kg/min and propofol 0.5 mg/kg if necessary) during the retrieval, and an RVH group, in which patients will receive conventional sedation (remifentanil 0.1 mcg/kg/min and propofol 0.5 mg/kg if necessary) and a Virtual Reality headset with an environment chosen by the patient and hypnosis support with suggestions to reduce their anxiety. To be included, patients must have undergone egg retrieval as part of their IVF at the Cliniques universitaires Saint-Luc, be French-speaking, have undergone simple IVF or ICSI IVF, and must not be undergoing long-term psychotherapeutic treatment or taking psychotropic medications. They must also have given their free, informed and written consent signed by the investigator and the patient in the days preceding the intervention. Patients with morbid obesity, blindness and/or deafness and with a history contraindicating the use of anti-inflammatory drugs will be excluded from the study.
- Conditions
- Oocyte Retrieval for IVF
- Being tested
- virtual reality hypnosis device
- Keywords
- virtual reality, hypnosis, oocyte retrieval
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality hypnosis deviceOther
VRH group, in which patients will receive conventional sedation (remifentanil 0.1 mcg/kg/min and propofol 0.5 mg/kg if necessary) and a Virtual Reality headset with an environment chosen by the patient and hypnosis support with suggestions to reduce their anxiety.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | sedation with remifentanil and propofol |
| RVH group | Experimental | RVH session + sedation with remifentanil and propofol Receives: Other: virtual reality hypnosis device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of this study is to compare VRH with a control group (usual sedation) on propofol consumption during the procedure.
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 posted5 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Oocyte Retrieval for IVFStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabienne Roelants, MD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104409
- Sponsor's protocol ID
- 2025/24JUI/253
- Other IDs
- VRH-IVF
- Acronym
- VRH-IVF
- Status last verified
- Jul 2025
- First submitted
- 29 Jul 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated and analyzed during the study will not be made available due to lack of consent for data sharing.
Publications
Rousseaux F, Panda R, Toussaint C, Bicego A, Niimi M, Faymonville ME, Nyssen AS, Laureys S, Gosseries O, Vanhaudenhuyse A. Virtual reality hypnosis in the management of pain: Self-reported and neurophysiological measures in healthy subjects. Eur J Pain. 2023 Jan;27(1):148-162. doi: 10.1002/ejp.2045. Epub 2022 Oct 24.
PubMed 36196745Pirard C, Laurent P, Wyns C, Giudice MG, Watremez C, Momeni M, Roelants F. Impact of virtual reality with or without hypnosis before oocyte retrieval: A randomised study. Complement Ther Med. 2025 Mar;88:103125. doi: 10.1016/j.ctim.2024.103125. Epub 2025 Jan 3.
PubMed 39756588Matsota P, Sidiropoulou T, Vrantza T, Boutsikou M, Midvighi E, Siristatidis C. Comparison of Two Different Sedation Protocols during Transvaginal Oocyte Retrieval: Effects on Propofol Consumption and IVF Outcome: A Prospective Cohort Study. J Clin Med. 2021 Mar 1;10(5):963. doi: 10.3390/jcm10050963.
PubMed 33804575
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Hypnosis as Sedation During Oocyte Retrieval: Effect on Propofol Consumption: a Randomized Study (VRH-IVF)
- ClinicalTrials.gov ID
- NCT07104409
- Acronym / sponsor ID
- VRH-IVF / 2025/24JUI/253
- Conditions
- Oocyte Retrieval for IVF
- Keywords
- virtual reality, hypnosis, oocyte retrieval
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 5 Aug 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.
An egg retrieval is performed during an IVF course. This painful procedure is performed using sedation to ensure patient comfort. A combination of sedative and analgesic medications combined with local anesthesia (paracervical block) is used. Propofol, the intravenous anesthetic of choice (rapid-acting and short-acting), and remifentanil (an ultra-short-acting opioid analgesic) are generally combined. The potential impact of these agents used for egg retrieval on egg fertilization and embryo quality is of interest. Indeed, certain drugs such as propofol could accumulate in the follicular fluid. The few studies conducted to date show contradictory results. While a harmful effect appears to be reported in experimental studies on mice, this effect is uncertain in clinical studies. Given this uncertainty, any method aimed at reducing propofol consumption in this context may be of interest. Virtual reality hypnosis (VRH) is a digital tool that has already been shown to be effective in reducing preoperative anxiety during oocyte retrieval. Furthermore, VRH has also demonstrated analgesic effects.
The primary objective of this study is to compare VRH with a control group (usual sedation) on propofol consumption during oocyte retrieval.
Secondary objectives are to compare preoperative anxiety, APAIS score, catastrophizing score, remifentanil consumption, intra- and/or post-operative nausea and vomiting, post-procedural analgesic consumption, time perception during the procedure, fertilization parameters, and pregnancy rate at 12 weeks. The degrees of absorption, dissociation, immersion, and presence for the VRH group will also be noted.
Detailed description
This is a prospective, single-center, randomized, controlled interventional study that will include 72 patients. Patients will be randomized into two groups: a Control group, in which patients will receive conventional sedation (remifentanil 0.1 mcg/kg/min and propofol 0.5 mg/kg if necessary) during the retrieval, and an RVH group, in which patients will receive conventional sedation (remifentanil 0.1 mcg/kg/min and propofol 0.5 mg/kg if necessary) and a Virtual Reality headset with an environment chosen by the patient and hypnosis support with suggestions to reduce their anxiety. To be included, patients must have undergone egg retrieval as part of their IVF at the Cliniques universitaires Saint-Luc, be French-speaking, have undergone simple IVF or ICSI IVF, and must not be undergoing long-term psychotherapeutic treatment or taking psychotropic medications. They must also have given their free, informed and written consent signed by the investigator and the patient in the days preceding the intervention. Patients with morbid obesity, blindness and/or deafness and with a history contraindicating the use of anti-inflammatory drugs will be excluded from the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –sedation with remifentanil and propofol |
| RVH group | Experimental | Other: virtual reality hypnosis deviceRVH session + sedation with remifentanil and propofol |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- egg retrieval as part of their IVF at the Cliniques universitaires Saint-Luc,
- to be French-speaking,
- simple IVF or ICSI IVF
- 18-42 yrs
Key exclusion criteria (4 listed)
- morbid obesity
- blindness and/or deafness
- history contraindicating the use of anti-inflammatory drugs
- long-term psychotherapeutic treatment or taking psychotropic medications.
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 |
|---|---|---|
| virtual reality hypnosis deviceVRH group, in which patients will receive conventional sedation (remifentanil 0.1 mcg/kg/min and propofol 0.5 mg/kg if necessary) and a Virtual Reality headset with an environment chosen by the patient and hypnosis support with suggestions to reduce their anxiety. | Other | RVH group |
Primary outcome
The primary outcome of this study is to compare VRH with a control group (usual sedation) on propofol consumption during the procedure.
Time frame: Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Background: PubMed 36196745Rousseaux F, Panda R, Toussaint C, Bicego A, Niimi M, Faymonville ME, Nyssen AS, Laureys S, Gosseries O, Vanhaudenhuyse A. Virtual reality hypnosis in the management of pain: Self-reported and neurophysiological measures in healthy subjects. Eur J Pain. 2023 Jan;27(1):148-162. doi: 10.1002/ejp.2045. Epub 2022 Oct 24.
- Background: PubMed 39756588Pirard C, Laurent P, Wyns C, Giudice MG, Watremez C, Momeni M, Roelants F. Impact of virtual reality with or without hypnosis before oocyte retrieval: A randomised study. Complement Ther Med. 2025 Mar;88:103125. doi: 10.1016/j.ctim.2024.103125. Epub 2025 Jan 3.
- Background: PubMed 33804575Matsota P, Sidiropoulou T, Vrantza T, Boutsikou M, Midvighi E, Siristatidis C. Comparison of Two Different Sedation Protocols during Transvaginal Oocyte Retrieval: Effects on Propofol Consumption and IVF Outcome: A Prospective Cohort Study. J Clin Med. 2021 Mar 1;10(5):963. doi: 10.3390/jcm10050963.
- Individual participant dataSharing planned: No. The datasets generated and analyzed during the study will not be made available due to lack of consent for data sharing.
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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.
Fabienne Roelants, MD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality hypnosis device in people with Oocyte Retrieval for IVF, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
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 4 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: opening soon, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabienne Roelants, MD (+3227641821, fabienne.roelants@saintluc.uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome of this study is to compare VRH with a control group (usual sedation) on propofol consumption during the procedure. (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07104409, which also lists 3 linked publications.
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 11 Aug 2025.