Oocyte RetrievalNCT06733701
The Use of Virtual Reality Technology During Oocyte Retrieval for in Vitro Fertilization
A study testing VR-based intervention (VRReliever Software V0.3.4 fromXRHealth) and VR headset without any scenery in people with Oocyte Retrieval and Adverse Events, run by Mount Sinai Hospital, Canada.
Trial summary
Ultrasound-guided oocyte retrieval (OR) is a short, but oftentimes painful procedure, during which the follicles are punctured trans-vaginally to obtain oocytes for in vitro fertilization (IVF). Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Oocyte Retrieval, Adverse Events, Procedural Anxiety
- What is being tested?
- VR-based intervention (VRReliever Software V0.3.4 fromXRHealth) and VR headset without any scenery
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2025to 31 Dec 2025
- 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 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All adults undergoing their first oocyte retrieval
Who cannot join
- severe visual impairment
- contraindications to using VR technology according to manufacturer specifications including:
- severe motion sickness
- epilepsy/previous seizure
- claustrophobia
- current migraine
- heart disease
- use of medical devices such as cardiac pacemaker or hearing aids
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: The Use of Virtual Reality Technology During Oocyte Retrieval for in Vitro Fertilization: a Randomized Controlled Pilot Study
Ultrasound-guided oocyte retrieval (OR) is a short, but oftentimes painful procedure, during which the follicles are punctured trans-vaginally to obtain oocytes for in vitro fertilization (IVF). Conscious sedation is the most commonly used method of pain relief, yet several studies have shown that more than half of women report moderate to high levels of pain and up to 7% of women report extreme or unacceptable levels of pain during OR. Adjuvant virtual reality (VR) therapy has been explored to reduce psychological stress during dental procedures, burn wound care, colonoscopy, as well as other minor procedures. Hence, the purpose of this study is to evaluate the use of VR technology during IVF treatment, particularly with respect to tolerability, patient satisfaction, and pain reduction during oocyte retrieval.
Read the detailed description
Background / Rationale
Ultrasound-guided oocyte retrieval (OR) is a short, but oftentimes painful procedure, during which the follicles are punctured trans-vaginally to obtain oocytes for in vitro fertilization (IVF). Conscious sedation is the most commonly used method of pain relief, yet several studies have shown that more than half of women report moderate to high levels of pain and up to 7% of women report extreme or unacceptable levels of pain during OR. Psycho-social factors such as anxiety, previous negative experiences with gynecological examinations, and perceived lack of control are important predictors of OR-related pain. This finding is consistent with the multidimensionality of the pain experience. Although several adjuvant therapies have been proposed to reduce psychological stress during ART (assisted reproductive technology) therapy, their impact on the OR experience has been mixed.
Virtual reality (VR) allows users to engage in a fully immersive simulated environment using an advanced visual and auditory system. Multimodal stimuli contribute to a sense of actual presence/immersion in the virtual world, thus making the VR experience distinct from passive visual or auditory stimuli. The utility of VR therapy has been explored for numerous health applications, showing positive outcomes in clinical conditions such as dental procedures, burn wound care, colonoscopy, as well as other minor procedures. A recent systematic review of 39 RCTs (randomized clinical trials) concluded that VR's immersive, entertaining effects are useful for redirecting a patient's attention away from painful treatment experiences and reducing anxiety, discomfort, and unpleasantness. Several studies have shown a significant decrease in pain perception and anxiety scores when treated with VR, as measured by anxiety questionnaires, pulse rate reduction, and electroencephalogram changes compared with controls. To the best of our knowledge, there are no published studies that examine the application of VR technology during IVF treatment, particularly with respect to tolerability, patient satisfaction, and pain reduction during oocyte retrieval.
Purpose
The primary objectives of this pilot study are to evaluate patient acceptance, perceived utility, and adverse effects of VR technology during the oocyte retrieval procedure as measured by validated VR-engagement and anxiety-related questionnaires
- Conditions
- Oocyte Retrieval, Adverse Events, Procedural Anxiety, Pain Intensity, Satisfaction, Medication Administration
- Being tested
- VR-based intervention (VRReliever Software V0.3.4 fromXRHealth), VR headset without any scenery
- Keywords
- Virtual Reality, Oocyte Retrieval, In Vitro Fertilization, Randomized Control Trial
- Medical subject headings
- Pain, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-based intervention (VRReliever Software V0.3.4 fromXRHealth)Device
The participant will be able to select between four VR environments: beach, lake, forest, or mountain scenery. Each provides an immersive audio and visual environment designed to reduce anxiety and promote relaxation. Each scene is rendered in a high-resolution and life-like fashion which participants can experience in a full 360 degrees. Participants will wear the headset for the duration of the egg retrieval procedure which is approximately 15-20 minutes.
VR headset without any sceneryDevice
VR headset without any scenery
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | During the procedure, patients will receive standard of care analgesia and VR-based intervention (VRReliever Software V0.3.4 fromXRHealth) Receives: Device: VR-based intervention (VRReliever Software V0.3.4 fromXRHealth) |
| Control | Placebo comparator | VR headset without any scenery Receives: Device: VR headset without any scenery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment satisfaction and immersion
measured by the IGroup Presence Questionnaire (IPQ) -Scaled 14-item questionnaire administered post-OR
Measured: 10 minutes
Adverse events
measured by the Simulator Sickness Questionnaire (SSQ) - Scaled 16-itemquestionnaire administered pre-OR and post-OR.
Measured: 20 minutes
Procedural anxiety
measured by the State-Trait Anxiety Inventory (STAI) Questionnaire -Scaled 20-item questionnaire administered at recruitment, pre-OR, and post-OR.
Measured: 20 minutes
Secondary outcomes (5)
Pain intensity
using the Numerical Rating Scale (20)
Measured: 10 minutes
Total opioid and benzodiazepine use
Dose for the procedure
Measured: 20 minutes
Duration of procedure
Measured: 20 minutes
Total number of oocytes retrieved / peak E2
Measured: 20 minutes
Total number of MII oocytes retrieved / number of follicles ≥ 17mm on day of trigger
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start15 Jan 2025 (estimated)
- Primary completion15 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a randomized, single-blinded, two-arm pilot study. Due to the nature of the intervention, participants cannot be blinded to allocation, but the physician performing the oocyte retrieval will be blinded to minimize the risk of bias.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Reproductive Endocrinology and Infertility
- Responsible party
- Principal investigator, Claire Jones, University of Toronto
- Investigators
- Claire Jones, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733701
- Sponsor's protocol ID
- 24-0033-E
- Status last verified
- Dec 2024
- First submitted
- 10 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are too few participants in the trial that they could potentially be identifiable.
Publications
Frederiksen Y, Mehlsen MY, Matthiesen SM, Zachariae R, Ingerslev HJ. Predictors of pain during oocyte retrieval. J Psychosom Obstet Gynaecol. 2017 Mar;38(1):21-29. doi: 10.1080/0167482X.2016.1235558. Epub 2016 Sep 27.
PubMed 27670651Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.
PubMed 21856077Mahrer NE, Gold JI. The use of virtual reality for pain control: a review. Curr Pain Headache Rep. 2009 Apr;13(2):100-9. doi: 10.1007/s11916-009-0019-8.
PubMed 19272275Gejervall AL, Stener-Victorin E, Cerne A, Borg K, Bergh C. Pain aspects in oocyte aspiration for IVF. Reprod Biomed Online. 2007 Feb;14(2):184-90. doi: 10.1016/s1472-6483(10)60786-9.
PubMed 17298721Kwan I, Wang R, Pearce E, Bhattacharya S. Pain relief for women undergoing oocyte retrieval for assisted reproduction. Cochrane Database Syst Rev. 2018 May 15;5(5):CD004829. doi: 10.1002/14651858.CD004829.pub4.
PubMed 29761478
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Virtual Reality Technology During Oocyte Retrieval for in Vitro Fertilization: a Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT06733701
- Acronym / sponsor ID
- 24-0033-E
- Conditions
- Oocyte Retrieval, Adverse Events, Procedural Anxiety, Pain Intensity, Satisfaction, Medication Administration
- Keywords
- Virtual Reality, Oocyte Retrieval, In Vitro Fertilization, Randomized Control Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- Reproductive Endocrinology and Infertility
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Dec 2024 (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.
Ultrasound-guided oocyte retrieval (OR) is a short, but oftentimes painful procedure, during which the follicles are punctured trans-vaginally to obtain oocytes for in vitro fertilization (IVF). Conscious sedation is the most commonly used method of pain relief, yet several studies have shown that more than half of women report moderate to high levels of pain and up to 7% of women report extreme or unacceptable levels of pain during OR. Adjuvant virtual reality (VR) therapy has been explored to reduce psychological stress during dental procedures, burn wound care, colonoscopy, as well as other minor procedures. Hence, the purpose of this study is to evaluate the use of VR technology during IVF treatment, particularly with respect to tolerability, patient satisfaction, and pain reduction during oocyte retrieval.
Detailed description
Background / Rationale
Ultrasound-guided oocyte retrieval (OR) is a short, but oftentimes painful procedure, during which the follicles are punctured trans-vaginally to obtain oocytes for in vitro fertilization (IVF). Conscious sedation is the most commonly used method of pain relief, yet several studies have shown that more than half of women report moderate to high levels of pain and up to 7% of women report extreme or unacceptable levels of pain during OR. Psycho-social factors such as anxiety, previous negative experiences with gynecological examinations, and perceived lack of control are important predictors of OR-related pain. This finding is consistent with the multidimensionality of the pain experience. Although several adjuvant therapies have been proposed to reduce psychological stress during ART (assisted reproductive technology) therapy, their impact on the OR experience has been mixed.
Virtual reality (VR) allows users to engage in a fully immersive simulated environment using an advanced visual and auditory system. Multimodal stimuli contribute to a sense of actual presence/immersion in the virtual world, thus making the VR experience distinct from passive visual or auditory stimuli. The utility of VR therapy has been explored for numerous health applications, showing positive outcomes in clinical conditions such as dental procedures, burn wound care, colonoscopy, as well as other minor procedures. A recent systematic review of 39 RCTs (randomized clinical trials) concluded that VR's immersive, entertaining effects are useful for redirecting a patient's attention away from painful treatment experiences and reducing anxiety, discomfort, and unpleasantness. Several studies have shown a significant decrease in pain perception and anxiety scores when treated with VR, as measured by anxiety questionnaires, pulse rate reduction, and electroencephalogram changes compared with controls. To the best of our knowledge, there are no published studies that examine the application of VR technology during IVF treatment, particularly with respect to tolerability, patient satisfaction, and pain reduction during oocyte retrieval.
Purpose
The primary objectives of this pilot study are to evaluate patient acceptance, perceived utility, and adverse effects of VR technology during the oocyte retrieval procedure as measured by validated VR-engagement and anxiety-related questionnaires
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- This will be a randomized, single-blinded, two-arm pilot study. Due to the nature of the intervention, participants cannot be blinded to allocation, but the physician performing the oocyte retrieval will be blinded to minimize the risk of bias.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: VR-based intervention (VRReliever Software V0.3.4 fromXRHealth)During the procedure, patients will receive standard of care analgesia and VR-based intervention (VRReliever Software V0.3.4 fromXRHealth) |
| Control | Placebo comparator | Device: VR headset without any sceneryVR headset without any scenery |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All adults undergoing their first oocyte retrieval
Key exclusion criteria (8 listed)
- severe visual impairment
- contraindications to using VR technology according to manufacturer specifications including:
- severe motion sickness
- epilepsy/previous seizure
- claustrophobia
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-based intervention (VRReliever Software V0.3.4 fromXRHealth)The participant will be able to select between four VR environments: beach, lake, forest, or mountain scenery. Each provides an immersive audio and visual environment designed to reduce anxiety and promote relaxation. Each scene is rendered in a high-resolution and life-like fashion which participants can experience in a full 360 degrees. Participants will wear the headset for the duration of the egg retrieval procedure which is approximately 15-20 minutes. | Device | Intervention |
| VR headset without any sceneryVR headset without any scenery | Device | Control |
Primary outcome
Treatment satisfaction and immersion
Time frame: 10 minutes
measured by the IGroup Presence Questionnaire (IPQ) -Scaled 14-item questionnaire administered post-OR
Adverse events
Time frame: 20 minutes
measured by the Simulator Sickness Questionnaire (SSQ) - Scaled 16-itemquestionnaire administered pre-OR and post-OR.
Procedural anxiety
Time frame: 20 minutes
measured by the State-Trait Anxiety Inventory (STAI) Questionnaire -Scaled 20-item questionnaire administered at recruitment, pre-OR, and post-OR.
5 secondary outcomes
Pain intensity
Time frame: 10 minutes
Total opioid and benzodiazepine use
Time frame: 20 minutes
Duration of procedure
Time frame: 20 minutes
Total number of oocytes retrieved / peak E2
Time frame: 20 minutes
Total number of MII oocytes retrieved / number of follicles ≥ 17mm on day of trigger
Time frame: 20 minutes
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 18 Dec 2024.
- Background: PubMed 27670651Frederiksen Y, Mehlsen MY, Matthiesen SM, Zachariae R, Ingerslev HJ. Predictors of pain during oocyte retrieval. J Psychosom Obstet Gynaecol. 2017 Mar;38(1):21-29. doi: 10.1080/0167482X.2016.1235558. Epub 2016 Sep 27.
- Background: PubMed 21856077Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.
- Background: PubMed 19272275Mahrer NE, Gold JI. The use of virtual reality for pain control: a review. Curr Pain Headache Rep. 2009 Apr;13(2):100-9. doi: 10.1007/s11916-009-0019-8.
- Background: PubMed 17298721Gejervall AL, Stener-Victorin E, Cerne A, Borg K, Bergh C. Pain aspects in oocyte aspiration for IVF. Reprod Biomed Online. 2007 Feb;14(2):184-90. doi: 10.1016/s1472-6483(10)60786-9.
- Background: PubMed 29761478Kwan I, Wang R, Pearce E, Bhattacharya S. Pain relief for women undergoing oocyte retrieval for assisted reproduction. Cochrane Database Syst Rev. 2018 May 15;5(5):CD004829. doi: 10.1002/14651858.CD004829.pub4.
- Individual participant dataSharing planned: No. There are too few participants in the trial that they could potentially be identifiable.
Related trials for Oocyte Retrieval
Not yet recruitingObservational study
Music Therapy and Sedation for Pain and Anxiety During Oocyte Retrieval
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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
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Not yet recruitingPhase 4
Exogenous Progesterone as Ovulation Trigger
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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.
Claire Jones, MD principal investigator
MOUNT SINAI HOSPITAL
Questions about this trial
What is this clinical trial studying?
A study testing VR-based intervention (VRReliever Software V0.3.4 fromXRHealth) and VR headset without any scenery in people with Oocyte Retrieval and Adverse Events, run by Mount Sinai Hospital, Canada.
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 1 inclusion and 8 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 18 Dec 2024. 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. 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?
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 Claire Jones, MD (416-586-4748, claire.jones@sinaihealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment satisfaction and immersion (time frame: 10 minutes). The study lists 3 primary outcomes in all. 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 NCT06733701, which also lists 5 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 18 Dec 2024.