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

NCT06733701 | Not Yet Recruiting

• 1 other identifier: 24-0033-E
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Treatment satisfaction and immersion

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

  10 minutes

• Adverse events

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

  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.

  20 minutes

Secondary Outcomes (5)

• Pain intensity

  10 minutes

• Total opioid and benzodiazepine use

  20 minutes

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

During the procedure, patients will receive standard of care analgesia and VR-based intervention (VRReliever Software V0.3.4 fromXRHealth)

Device: VR-based intervention (VRReliever Software V0.3.4 fromXRHealth)

Control

PLACEBO COMPARATOR

VR headset without any scenery

Device: VR headset without any scenery

Interventions

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.

Intervention

VR headset without any scenery DEVICE

VR headset without any scenery

Control

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- All adults undergoing their first oocyte retrieval

You may not qualify if:

• 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

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead
• Reproductive Endocrinology and Infertility: collaborator

Related Publications (5)

• 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.

  PMID: 27670651 BACKGROUND

• 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.

  PMID: 21856077 BACKGROUND

• 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.

  PMID: 19272275 BACKGROUND

• 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.

  PMID: 17298721 BACKGROUND

• 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.

  PMID: 29761478 BACKGROUND

MeSH Terms

Conditions

Pain; Personal Satisfaction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Claire Jones, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire Jones, MD

CONTACT

416-586-4748; claire.jones@sinaihealth.ca

Swati Dixit, PhD

CONTACT

4165868888; swati.dixit@sinaihealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: January 15, 2025
• Primary Completion: July 15, 2025
• Study Completion: December 31, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share