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NCT Number: NCT06733701

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

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 scenery

Device

VR headset without any scenery

Primary outcomes

  1. Treatment satisfaction and immersion

    Time frame: 10 minutes

    measured by the IGroup Presence Questionnaire (IPQ) -Scaled 14-item questionnaire administered post-OR

  2. Adverse events

    Time frame: 20 minutes

    measured by the Simulator Sickness Questionnaire (SSQ) - Scaled 16-itemquestionnaire administered pre-OR and post-OR.

  3. 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.

Secondary outcomes

  1. Pain intensity

    Time frame: 10 minutes

    using the Numerical Rating Scale (20)

  2. Total opioid and benzodiazepine use

    Time frame: 20 minutes

    Dose for the procedure

  3. Duration of procedure

    Time frame: 20 minutes

  4. Total number of oocytes retrieved / peak E2

    Time frame: 20 minutes

  5. Total number of MII oocytes retrieved / number of follicles ≥ 17mm on day of trigger

    Time frame: 20 minutes

Study contacts

Contact information is provided by the study sponsor or research team.

Claire Jones, MD

CONTACT

[email protected]

416-586-4748

Swati Dixit, PhD

CONTACT

[email protected]

4165868888 ext. 7151

Sponsors and collaborators

Lead sponsor

Mount Sinai Hospital, Canada

Other

Collaborators

  • Reproductive Endocrinology and Infertility

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 13, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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