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The Use of Virtual Reality Technology During Oocyte Retrieval for in Vitro Fertilization

The Use of Virtual Reality Technology During Oocyte Retrieval for in Vitro Fertilization: a Randomized Controlled Pilot Study

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06733701
Enrollment
50
Registered
2024-12-13
Start date
2025-01-15
Completion date
2025-12-31
Last updated
2024-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Events, Medication Administration, Oocyte Retrieval, Pain Intensity, Procedural Anxiety, Satisfaction

Keywords

Virtual Reality, Oocyte Retrieval, In Vitro Fertilization, Randomized Control Trial

Brief 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). 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

Interventions

DEVICEVR-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.

DEVICEVR headset without any scenery

VR headset without any scenery

Sponsors

Reproductive Endocrinology and Infertility
CollaboratorUNKNOWN
Mount Sinai Hospital, Canada
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)

Intervention 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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
No

Inclusion criteria

\- All adults undergoing their first oocyte retrieval

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Treatment satisfaction and immersion10 minutesmeasured by the IGroup Presence Questionnaire (IPQ) -Scaled 14-item questionnaire administered post-OR
Adverse events20 minutesmeasured by the Simulator Sickness Questionnaire (SSQ) - Scaled 16-itemquestionnaire administered pre-OR and post-OR.
Procedural anxiety20 minutesmeasured by the State-Trait Anxiety Inventory (STAI) Questionnaire -Scaled 20-item questionnaire administered at recruitment, pre-OR, and post-OR.

Secondary

MeasureTime frameDescription
Total number of oocytes retrieved / peak E220 minutes
Pain intensity10 minutesusing the Numerical Rating Scale (20)
Total number of MII oocytes retrieved / number of follicles ≥ 17mm on day of trigger20 minutes
Total opioid and benzodiazepine use20 minutesDose for the procedure
Duration of procedure20 minutes

Contacts

Primary ContactClaire Jones, MD
claire.jones@sinaihealth.ca416-586-4748
Backup ContactSwati Dixit, PhD
swati.dixit@sinaihealth.ca4165868888

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026