Clinical trial NCT06733701: The Use of Virtual Reality Technology During Oocyte Retrieval for in Vitro Fertilization
Official title: The Use of Virtual Reality Technology During Oocyte Retrieval for in Vitro Fertilization: a Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Oocyte Retrieval
Adverse Events
Procedural Anxiety
Pain Intensity
Satisfaction
Medication Administration
Keywords: Virtual Reality
Oocyte Retrieval
In Vitro Fertilization
Randomized Control Trial
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
Collaborators: name: Reproductive Endocrinology and Infertility
First posted: 2024-12-13
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Treatment satisfaction and immersion
timeFrame: 10 minutes
measure: Adverse events
timeFrame: 20 minutes
measure: Procedural anxiety
timeFrame: 20 minutes
Secondary outcomes:
measure: Pain intensity
timeFrame: 10 minutes
measure: Total opioid and benzodiazepine use
timeFrame: 20 minutes
measure: Duration of procedure
timeFrame: 20 minutes
measure: Total number of oocytes retrieved / peak E2
timeFrame: 20 minutes
measure: Total number of MII oocytes retrieved / number of follicles ≥ 17mm on day of trigger
timeFrame: 20 minutes
Other outcomes:
Locations:
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Claire Jones, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Ferreira-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.
citation: Mahrer 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.
citation: Gejervall 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.
citation: Kwan 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.