IVFVitRoNCT05555498
Virtual Reality for Anxiety and Pain Management During Oocyte Retrieval in IVF/ICSI Treatment
A study testing Virtual Reality glasses in people with IVF and Procedural Pain, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
Despite current anxiety and pain management during oocyte retrieval in IVF/ICSI treatment by conscious sedation, oocyte retrieval often remains painful and stressful for patients. An average pain score of 6.0 (expressed using VAS) and stress score of 41.63 (using STAI-S) were reported by previous researches. Read more about this study
- Who is it for?
- Ages 18 to 43 years
- Conditions the study is for
- IVF, Procedural Pain, Procedural Anxiety
- What is being tested?
- Virtual Reality glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2022to 1 May 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between 18 and 43 years of age;
- Undergoing oocyte retrieval as part of IVF/ICSI treatment;
- Be able to understand and read the Dutch or English language.
Who cannot join
- Chronic use of pain medication;
- Chronic use of anti-depressants or sedatives;
- Women who previously underwent an oocyte retrieval with a VR intervention;
- Women undergoing oocyte retrieval because of fertility preservation;
- Women with visual or auditive impairment;
- Technology-related sensitivity such as motion-sickness, dizziness, epilepsy, seizures, active nausea and vomiting;
- Women who are not willing or able to give their informed consent.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Amsterdam UMC, location VUmc
Amsterdam, North Holland, 1081 HV
Annelotte A.P. van Haaps, Drs, 0204445277 ext. 020, a.vanhaaps@amsterdamumc.nl
Velja V Mijatovic, Prof. Dr., 0204445277, mijatovic@amsterdamumc.nl
About this study
Despite current anxiety and pain management during oocyte retrieval in IVF/ICSI treatment by conscious sedation, oocyte retrieval often remains painful and stressful for patients. An average pain score of 6.0 (expressed using VAS) and stress score of 41.63 (using STAI-S) were reported by previous researches. Previous research showed there might be a negative correlation between anxiety experienced in IVF/ICSI treatment, and ongoing pregnancy rate. Other researches nuance this. In addition, conscious sedation can give a variety of side effects such as apnea and respiratory depression.
The appliance of Virtual Reality is increasingly researched, in a variety of procedures. Previous researches showed that Virtual Reality was effective in the reduction of anxiety and pain experienced, also in the field of Gynaecology and Obstetrics. We hypothesized that Virtual Reality can aid in the reduction of anxiety and pain experienced during oocyte retrieval in IVF/ICSI treatment. We also aim to find a definitive answer on the question whether anxiety during IVF/ICSI treatment can negatively influence ongoing pregnancy rates.
Read the detailed description
Patients undergoing oocyte retrieval as part of IVF/ICSI treatment are often still anxious and experience pain despite adequate management of both by applying conscious sedation, consisting of opioids combined with benzodiazepines. An average pain score of 6.0 during oocyte retrieval is reported by patients, expressed using the Visual Analogue Score (VAS). Very limited research has been done on anxiety experienced during oocyte retrieval by patients. However, in 2013 Turner et al. reported an average anxiety score of 41.63, objectified using the State-Trait Anxiety Inventory (STAI-S) of Spielberger et al. They also saw a higher pregnancy rate in women reporting a lower anxiety score (34.93 in pregnant women versus 44.35 in non-pregnant women, p=0.05). This finding was nuanced by other researches, they found no correlation between anxiety and IVF/ICSI outcomes.
There is an increased risk of side effects when benzodiazepines are added to opioids to induce conscious sedation. Due to the anxiolytic, sedative and amnesic effect of benzodiazepines, a reduction in anxiety experienced by patients is seen. Benzodiazepines combined with opioids additionally cause a depression of the central nervous system, resulting in a conscious sedative state. The patient is still fully conscious and able to communicate with the healthcare provider. However, the risk of respiratory side effects such as respiratory depression and apnea increases when conscious sedation is applied. No successful alternative to benzodiazepines has yet been found.
Virtual Reality is increasingly used successfully to reduce both anxiety and pain experienced by patients during a variety of procedures. Additionally, higher satisfaction scores by both the patient and care giver are reported when Virtual Reality was applied. By deriving the patient's cognition from the procedural pain using a Virtual Reality environment, subjective pain experienced by the patient is reduced. VR is increasingly used in the medical field, including in the field of Gynecology and Obstetrics. However, no studies have yet been conducted on the effectiveness of VR during oocyte retrieval.
Based on previous studies, where reduced pain and anxiety was seen when Virtual Reality was applied, we hypothesized that a VR intervention can aid in the reduction of pain and anxiety experienced by patients during oocyte retrieval. In addition, we hypothesize there is a higher ongoing pregnancy rate in women experiencing less anxiety during oocyte retrieval.
- Conditions
- IVF, Procedural Pain, Procedural Anxiety
- Being tested
- Virtual Reality glasses
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality glassesDevice
The intervention used are Virtual Reality glasses. The VR-glasses used are designed by SyncVR medical (Utrecht, the Netherlands), and are applicable specifically for medical use. By distracting the patients' cognition from the procedure, using images and sounds, the patient hopefully experiences less pain and anxiety. Women can choose between relaxation excersises and nature films
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: VR-glasses added to standard care of conscious sedation | Experimental | For the intervention group, Virtual Reality glasses will be administered on top of standard pain and anxiety management. Standard pain and management consists of conscious sedation, where benzodiazepines and opioids are administrered. In addition, participants are asked to complete 4 questionnaires on different times : immediately before, immediately after and three days after oocyte retrieval. In case of ongoing pregnancy, women are asked to complete a questionnaire approximately a month after their expected date of delivery. Receives: Device: Virtual Reality glasses |
| standard care consisting of conscious sedation | No intervention | The control group will receive standard pain- and anxiety management during oocyte retrieval in IVF/ICSI treatment, consisting of opioids combined with benzodiazepines. This will result in a conscious sedated state. In addition, participants are asked to complete 4 questionnaires on different times : immediately before, immediately after and three days after oocyte retrieval. In case of ongoing pregnancy, women are asked to complete a questionnaire approximately a month after their expected date of delivery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of anxiety during oocyte retrieval
Assessed using the STAI-S. A score between 20 and 80 can be calculated. The higher the score, the more severe the anxiety experienced is.
Measured: 2 hours
Secondary outcomes (8)
Reduction of pain scores during oocyte retrieval
Measured using a VAS-score, scale 0-10. The higher the VAS-score, the more pain the participant exprienced.
Measured: 2 hours
Duration of the procedure
When the patients' anxiety is reduced, it is expected that she is more relaxed and the procedure will run more smoothly resulting in a shorter duration of the procedure.
Measured: 2 hours
Satisfaction score of the patient
Measured using the Numeric Rating Scale, with a scale from 0 to 10. The higher the NRS-score, the higher patient satisfaction.
Measured: 2 hours
satisfaction score of the care giver
Measured using the Numeric Rating Scale, with a scale from 0 to 10. The higher the NRS-score, the higher care giver satisfaction.
Measured: 2 hours
Occurrence of side effects
Measured using a questionnaire, with a 5-point Likert Scale.
Measured: 3 days
Ongoing pregnancy rate
Defined as the precence of a heart beat at 10 to 12 weeks gestation
Measured: 10 months
Use of oral analgesics
Possible need for pain medication until 3 days after oocyte retrieval. Measured using a questionnaire that is send 3 days after oocyte retrieval.
Measured: 3 days
Immersiveness in the VR program
Measured using a questionnaire, with a 5-point Likert Scale.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start1 Nov 2022 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IVFStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe 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
- Randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Velja Mijatovic, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555498
- Sponsor's protocol ID
- 2010170
- Acronym
- VitRo
- Status last verified
- Sep 2022
- First submitted
- 4 Mar 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No trial data will be shared with other researchers. Only the researchers involved in the trial will be able to see the data. All participants will be assigned an anonymous code. To this code, all study data will be collected. The key to the codes will be stored at the research center, in a sealed digital map.
Publications
van Haaps AP, Schreurs AMF, Rosielle K, Mijatovic V, Kallewaard JW, Dreyer K. No anxiety or pain reduction by Virtual Reality during oocyte retrieval in IVF/ICSI treatment: results of a randomized controlled trial. Hum Reprod. 2026 Jan 1;41(1):39-49. doi: 10.1093/humrep/deaf193.
PubMed 41057042
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality for Anxiety and Pain Management During Oocyte Retrieval in IVF/ICSI Treatment
- ClinicalTrials.gov ID
- NCT05555498
- Acronym / sponsor ID
- VitRo / 2010170
- Conditions
- IVF, Procedural Pain, Procedural Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 27 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.
Despite current anxiety and pain management during oocyte retrieval in IVF/ICSI treatment by conscious sedation, oocyte retrieval often remains painful and stressful for patients. An average pain score of 6.0 (expressed using VAS) and stress score of 41.63 (using STAI-S) were reported by previous researches. Previous research showed there might be a negative correlation between anxiety experienced in IVF/ICSI treatment, and ongoing pregnancy rate. Other researches nuance this. In addition, conscious sedation can give a variety of side effects such as apnea and respiratory depression.
The appliance of Virtual Reality is increasingly researched, in a variety of procedures. Previous researches showed that Virtual Reality was effective in the reduction of anxiety and pain experienced, also in the field of Gynaecology and Obstetrics. We hypothesized that Virtual Reality can aid in the reduction of anxiety and pain experienced during oocyte retrieval in IVF/ICSI treatment. We also aim to find a definitive answer on the question whether anxiety during IVF/ICSI treatment can negatively influence ongoing pregnancy rates.
Detailed description
Patients undergoing oocyte retrieval as part of IVF/ICSI treatment are often still anxious and experience pain despite adequate management of both by applying conscious sedation, consisting of opioids combined with benzodiazepines. An average pain score of 6.0 during oocyte retrieval is reported by patients, expressed using the Visual Analogue Score (VAS). Very limited research has been done on anxiety experienced during oocyte retrieval by patients. However, in 2013 Turner et al. reported an average anxiety score of 41.63, objectified using the State-Trait Anxiety Inventory (STAI-S) of Spielberger et al. They also saw a higher pregnancy rate in women reporting a lower anxiety score (34.93 in pregnant women versus 44.35 in non-pregnant women, p=0.05). This finding was nuanced by other researches, they found no correlation between anxiety and IVF/ICSI outcomes.
There is an increased risk of side effects when benzodiazepines are added to opioids to induce conscious sedation. Due to the anxiolytic, sedative and amnesic effect of benzodiazepines, a reduction in anxiety experienced by patients is seen. Benzodiazepines combined with opioids additionally cause a depression of the central nervous system, resulting in a conscious sedative state. The patient is still fully conscious and able to communicate with the healthcare provider. However, the risk of respiratory side effects such as respiratory depression and apnea increases when conscious sedation is applied. No successful alternative to benzodiazepines has yet been found.
Virtual Reality is increasingly used successfully to reduce both anxiety and pain experienced by patients during a variety of procedures. Additionally, higher satisfaction scores by both the patient and care giver are reported when Virtual Reality was applied. By deriving the patient's cognition from the procedural pain using a Virtual Reality environment, subjective pain experienced by the patient is reduced. VR is increasingly used in the medical field, including in the field of Gynecology and Obstetrics. However, no studies have yet been conducted on the effectiveness of VR during oocyte retrieval.
Based on previous studies, where reduced pain and anxiety was seen when Virtual Reality was applied, we hypothesized that a VR intervention can aid in the reduction of pain and anxiety experienced by patients during oocyte retrieval. In addition, we hypothesize there is a higher ongoing pregnancy rate in women experiencing less anxiety during oocyte retrieval.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group: VR-glasses added to standard care of conscious sedation | Experimental | Device: Virtual Reality glassesFor the intervention group, Virtual Reality glasses will be administered on top of standard pain and anxiety management. Standard pain and management consists of conscious sedation, where benzodiazepines and opioids are administrered. In addition, participants are asked to complete 4 questionnaires on different times : immediately before, immediately after and three days after oocyte retrieval. In case of ongoing pregnancy, women are asked to complete a questionnaire approximately a month after their expected date of delivery. |
| standard care consisting of conscious sedation | No intervention | –The control group will receive standard pain- and anxiety management during oocyte retrieval in IVF/ICSI treatment, consisting of opioids combined with benzodiazepines. This will result in a conscious sedated state. In addition, participants are asked to complete 4 questionnaires on different times : immediately before, immediately after and three days after oocyte retrieval. In case of ongoing pregnancy, women are asked to complete a questionnaire approximately a month after their expected date of delivery. |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Between 18 and 43 years of age;
- Undergoing oocyte retrieval as part of IVF/ICSI treatment;
- Be able to understand and read the Dutch or English language.
Key exclusion criteria (7 listed)
- Chronic use of pain medication;
- Chronic use of anti-depressants or sedatives;
- Women who previously underwent an oocyte retrieval with a VR intervention;
- Women undergoing oocyte retrieval because of fertility preservation;
- Women with visual or auditive impairment;
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 glassesThe intervention used are Virtual Reality glasses. The VR-glasses used are designed by SyncVR medical (Utrecht, the Netherlands), and are applicable specifically for medical use. By distracting the patients' cognition from the procedure, using images and sounds, the patient hopefully experiences less pain and anxiety. Women can choose between relaxation excersises and nature films | Device | Intervention group: VR-glasses added to standard care of conscious sedation |
Primary outcome
Reduction of anxiety during oocyte retrieval
Time frame: 2 hours
Assessed using the STAI-S. A score between 20 and 80 can be calculated. The higher the score, the more severe the anxiety experienced is.
8 secondary outcomes
Reduction of pain scores during oocyte retrieval
Time frame: 2 hours
Duration of the procedure
Time frame: 2 hours
Satisfaction score of the patient
Time frame: 2 hours
satisfaction score of the care giver
Time frame: 2 hours
Occurrence of side effects
Time frame: 3 days
Ongoing pregnancy rate
Time frame: 10 months
Use of oral analgesics
Time frame: 3 days
Immersiveness in the VR program
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Derived from this study: PubMed 41057042van Haaps AP, Schreurs AMF, Rosielle K, Mijatovic V, Kallewaard JW, Dreyer K. No anxiety or pain reduction by Virtual Reality during oocyte retrieval in IVF/ICSI treatment: results of a randomized controlled trial. Hum Reprod. 2026 Jan 1;41(1):39-49. doi: 10.1093/humrep/deaf193.
- Individual participant dataSharing planned: No. No trial data will be shared with other researchers. Only the researchers involved in the trial will be able to see the data. All participants will be assigned an anonymous code. To this code, all study data will be collected. The key to the codes will be stored at the research center, in a sealed digital map.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality glasses in people with IVF and Procedural Pain, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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 3 inclusion and 7 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 27 Sep 2022. 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 Netherlands. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of anxiety during oocyte retrieval (time frame: 2 hours). 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 NCT05555498, which also lists 1 linked publication.
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 27 Sep 2022.