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

Not Applicable

Not yet recruiting

• Conditions: Oocyte Retrieval; Adverse Events; Procedural Anxiety; Pain Intensity; Satisfaction; Medication Administration

• Registration Number: NCT06733701
• Lead Sponsor: Mount Sinai Hospital, Canada

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

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-10
• Study First Posted: 2024-12-13
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-18
• Study Start: 2025-01-15
• Primary Completion: 2025-07-15
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Treatment satisfaction and immersion	10 minutes	measured by the IGroup Presence Questionnaire (IPQ) -Scaled 14-item questionnaire administered post-OR
Adverse events	20 minutes	measured by the Simulator Sickness Questionnaire (SSQ) - Scaled 16-itemquestionnaire administered pre-OR and post-OR.
Procedural anxiety	20 minutes	measured by the State-Trait Anxiety Inventory (STAI) Questionnaire -Scaled 20-item questionnaire administered at recruitment, pre-OR, and post-OR.

Secondary Outcome Measures

Name	Time	Method
Pain intensity	10 minutes	using the Numerical Rating Scale (20)
Total opioid and benzodiazepine use	20 minutes	Dose for the procedure
Duration of procedure	20 minutes
Total number of oocytes retrieved / peak E2	20 minutes
Total number of MII oocytes retrieved / number of follicles ≥ 17mm on day of trigger	20 minutes