InfertilityNCT05438238
Virtual Reality for Acute Pain and Anxiety During Egg Retrieval for in Vitro Fertility Treatment
A study testing Oncomfort in people with Infertility and In Vitro Fertilization, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
This study is a comparison between the current standard practice of performing a transvaginal oocyte retrieval (TVOR) with paracervical block (PCB) and a relatively recently developed technology of virtual reality that is added to the above mentioned standard practice of TVOR + PCB. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, In Vitro Fertilization, IVF
- What is being tested?
- Oncomfort
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2023to Dec 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female
- ≥18 and ≤ 40 years of age
- undergoing fertility treatments
- undergoing egg retrieval as part of in vitro fertilization treatment
- only first ≤ 3 IVF cycles.
- Bilateral ovarian follicular response (>3 and <30 follicles)
Who cannot join
- Hearing impairments and blindness
- Motion sickness
- Any known anatomical characteristics that may make performing the office procedure impossible.
- Patients undergoing a general anesthesia or conscious sedation
- lack of informed consent
- Chronic alcohol/drug abusers
Show all 9Show fewer
- Transabdominal approach for retrieval
- Patients undergoing oocyte retrieval for fertility preservation before cancer or genotoxic treatment - oncofertility preservation
- allergy to medications used
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Brussel CRG
Jette, Brussels Capital, 1090
valerie schutyser
About this study
Official title: Clinical Efficacy of Virtual Reality for Acute Pain and Anxiety Management During Egg Retrieval for in Vitro Fertility Treatment
This study is a comparison between the current standard practice of performing a transvaginal oocyte retrieval (TVOR) with paracervical block (PCB) and a relatively recently developed technology of virtual reality that is added to the above mentioned standard practice of TVOR + PCB. The aim of the study is to find out whether this newer technology has an advantage for the patient, in terms of anxiety and pain reduction or satisfaction.
Read the detailed description
People who wish to become pregnant sometimes have to resort to in vitro fertilisation (IVF) treatment. IVF treatment consists of the injection of hormones on one hand, and the creation and transfer of embryos on the other, with a view to pregnancy. The first part, the hormonal ovarian stimulation, leads to an egg retrieval through the maturation trigger 36h before. On the one hand, people may be very anxious about the unknown procedure, as they do not know what to expect. Due to the fertility problems and fertility treatments with its disappointments, there is also a psychological burden to be taken into consideration. On the other hand, people may experience this procedure as painful, although this varies greatly. Scientific studies show that 90% of women are comfortable during transvaginal oocyte retrieval under local anaesthetic and do not want additional painkillers.
Virtual reality has emerged in recent years as an alternative non-pharmacological treatment that has proven to be effective in treating burns, postpartum episiotomy suturing or in paediatric care.
The aim of this study is to investigate the alternative treatment (Virtual Reality glasses) for its effectiveness in treating anxiety and pain while undergoing transvaginal oocyte retrieval. The Virtual reality headmounted glasses by Oncomfort, CE certified,is a set of headphones with a smartphone screen that offers image and sound as a treatment, during the transvaginal oocyte retrieval, i.e. about 20-30 minutes.
Questionnaires will be filled out by the patients and the physician to evaluate expectations, fear and pain.
Prior to the TVOR, the patient will fill out the pre-operative questionnaire, which will interview their baseline fear, anxiety and expectations. Each patient is instructed on the use of the standard 100mm linear visual analog scale (VAS) with 0 as no pain and 10.0 as the worst pain imaginable.
In their room, after the TVOR, the patient will receive a second questionnaire (within 4h after oocyte retrieval, before leaving the hospital) about how the subject has experienced the exam, in general, at the worst moment, how attractive and immersive the VR was, and whether she would want to use the VR again.
Five days after the egg retrieval, the patient receives a third and last questionnaire on the experiences of the remaining day of the egg retrieval as well as the following days.
- Conditions
- Infertility, In Vitro Fertilization, IVF, ART
- Being tested
- Oncomfort
- Keywords
- virtual reality, infertility, transvaginal oocyte retrieval, IVF, in vitro fertilization
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OncomfortDevice
Virtual Reality
| Study group | Role | What they receive |
|---|---|---|
| investigational group A | Experimental | during TVOR +PCB addition of Oncomfort, commercially available Virtual Reality headset, consisting of headphones with smartphone glasses - see oncomfort.com/en, CE approval conform IEC62366-1:2015, EN 62304:2006/Amd1:2015, EN 82304-1:2015, EN 82304-1:2016, ISO 13485:2016, EN ISO 14971:2019, EN 60601-1-2:2015 Receives: Device: Oncomfort |
| reference group | No intervention | standard of care TVOR + PCB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in visual analog scale score for Pain
change in pain experience, assessed using visual analog scale (VAS). VAS is a 100mm linear visual analog scale with 0 as no pain and 10.0 as the worst pain imaginable.
Measured: 1/ pre-procedure baseline 2/ immediately after the procedure and 3/ 5days after TVOR
Secondary outcomes (1)
Difference in visual analog scale score for anxiety
change in anxiety experience, assessed using visual analog scale (VAS). VAS is a 100mm linear visual analog scale with 0 as no fear and 10.0 as the worst fear imaginable/ dying of fear
Measured: 1/ pre-procedure baseline 2/ immediately after the procedure and 3/ 5days after TVOR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start1 Feb 2023
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- Model description
- This study is a comparison between the current standard practice of performing an egg retrieval with paracervical block (PCB) and virtual reality that is added to the above mentioned standard practice of TVOR + PCB. The aim of the study is to find out whether this newer technology has an advantage for the patient, in terms of anxiety and pain reduction, by aid of questionnaires
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe Blockeel, MD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438238
- Sponsor's protocol ID
- VR-OPU
- Status last verified
- Jun 2022
- First submitted
- 24 Jun 2022
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: all data will be anonymized before sharing with statistician
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Virtual Reality for Acute Pain and Anxiety Management During Egg Retrieval for in Vitro Fertility Treatment
- ClinicalTrials.gov ID
- NCT05438238
- Acronym / sponsor ID
- VR-OPU
- Conditions
- Infertility, In Vitro Fertilization, IVF, ART
- Keywords
- virtual reality, infertility, transvaginal oocyte retrieval, IVF, in vitro fertilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 29 Jun 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.
This study is a comparison between the current standard practice of performing a transvaginal oocyte retrieval (TVOR) with paracervical block (PCB) and a relatively recently developed technology of virtual reality that is added to the above mentioned standard practice of TVOR + PCB. The aim of the study is to find out whether this newer technology has an advantage for the patient, in terms of anxiety and pain reduction or satisfaction.
Detailed description
People who wish to become pregnant sometimes have to resort to in vitro fertilisation (IVF) treatment. IVF treatment consists of the injection of hormones on one hand, and the creation and transfer of embryos on the other, with a view to pregnancy. The first part, the hormonal ovarian stimulation, leads to an egg retrieval through the maturation trigger 36h before. On the one hand, people may be very anxious about the unknown procedure, as they do not know what to expect. Due to the fertility problems and fertility treatments with its disappointments, there is also a psychological burden to be taken into consideration. On the other hand, people may experience this procedure as painful, although this varies greatly. Scientific studies show that 90% of women are comfortable during transvaginal oocyte retrieval under local anaesthetic and do not want additional painkillers.
Virtual reality has emerged in recent years as an alternative non-pharmacological treatment that has proven to be effective in treating burns, postpartum episiotomy suturing or in paediatric care.
The aim of this study is to investigate the alternative treatment (Virtual Reality glasses) for its effectiveness in treating anxiety and pain while undergoing transvaginal oocyte retrieval. The Virtual reality headmounted glasses by Oncomfort, CE certified,is a set of headphones with a smartphone screen that offers image and sound as a treatment, during the transvaginal oocyte retrieval, i.e. about 20-30 minutes.
Questionnaires will be filled out by the patients and the physician to evaluate expectations, fear and pain.
Prior to the TVOR, the patient will fill out the pre-operative questionnaire, which will interview their baseline fear, anxiety and expectations. Each patient is instructed on the use of the standard 100mm linear visual analog scale (VAS) with 0 as no pain and 10.0 as the worst pain imaginable.
In their room, after the TVOR, the patient will receive a second questionnaire (within 4h after oocyte retrieval, before leaving the hospital) about how the subject has experienced the exam, in general, at the worst moment, how attractive and immersive the VR was, and whether she would want to use the VR again.
Five days after the egg retrieval, the patient receives a third and last questionnaire on the experiences of the remaining day of the egg retrieval as well as the following days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a comparison between the current standard practice of performing an egg retrieval with paracervical block (PCB) and virtual reality that is added to the above mentioned standard practice of TVOR + PCB. The aim of the study is to find out whether this newer technology has an advantage for the patient, in terms of anxiety and pain reduction, by aid of questionnaires
| Arm | Type | Receives |
|---|---|---|
| investigational group A | Experimental | Device: Oncomfortduring TVOR +PCB addition of Oncomfort, commercially available Virtual Reality headset, consisting of headphones with smartphone glasses - see oncomfort.com/en, CE approval conform IEC62366-1:2015, EN 62304:2006/Amd1:2015, EN 82304-1:2015, EN 82304-1:2016, ISO 13485:2016, EN ISO 14971:2019, EN 60601-1-2:2015 |
| reference group | No intervention | –standard of care TVOR + PCB |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- female
- ≥18 and ≤ 40 years of age
- undergoing fertility treatments
- undergoing egg retrieval as part of in vitro fertilization treatment
- only first ≤ 3 IVF cycles.
Key exclusion criteria (9 listed)
- Hearing impairments and blindness
- Motion sickness
- Any known anatomical characteristics that may make performing the office procedure impossible.
- Patients undergoing a general anesthesia or conscious sedation
- lack of informed consent
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 |
|---|---|---|
| OncomfortVirtual Reality | Device | investigational group A |
Primary outcome
Difference in visual analog scale score for Pain
Time frame: 1/ pre-procedure baseline 2/ immediately after the procedure and 3/ 5days after TVOR
change in pain experience, assessed using visual analog scale (VAS). VAS is a 100mm linear visual analog scale with 0 as no pain and 10.0 as the worst pain imaginable.
1 secondary outcome
Difference in visual analog scale score for anxiety
Time frame: 1/ pre-procedure baseline 2/ immediately after the procedure and 3/ 5days after TVOR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Individual participant dataSharing planned: No. all data will be anonymized before sharing with statistician
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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.
Christophe Blockeel, MD principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oncomfort in people with Infertility and In Vitro Fertilization, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 9 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: status not confirmed, as of the sponsor's last update on 18 May 2023. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valerie Schutyser, MD (+32 2 477 2676, dr.valerie.schutyser@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in visual analog scale score for Pain (time frame: 1/ pre-procedure baseline 2/ immediately after the procedure and 3/ 5days after TVOR). 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 18 May 2023.