Exciting developments are emerging in the quest to improve patient experiences during medically assisted procreation (MAP) procedures. A monocentric randomised controlled trial is now recruiting participants to examine whether virtual reality-enhanced audiovisual distraction can reduce the use of hypnotic agents, specifically Propofol, during IVF/ICSI oocyte retrieval.
This clinical trial, sponsored by Groupe Hospitalier Diaconesses Croix Saint-Simon, could bring new technologies into routine MAP practices while improving safety and comfort for patients. Clinical, regulatory, and quality teams interested in sedation alternatives will find this study particularly relevant.
What are the trial details?
This randomised controlled trial aims to study whether virtual reality (VR)-assisted audiovisual distraction can reduce the use of hypnotic sedatives during invasive oocyte retrieval procedures conducted in the context of IVF/ICSI. Two groups of participants will be compared:
- Group 1: Receive Propofol sedation paired with VR-enhanced audiovisual distraction devices as an intervention.
- Group 2: Standard care involving Propofol sedation without additional audiovisual distraction tools.
The trial is open for recruitment, according to the sponsor’s report from Groupe Hospitalier Diaconesses Croix Saint-Simon.
How does VR affect the use of hypnotic agents?
Hypnotic agents, such as Propofol, are commonly used during oocyte retrieval to ensure patient comfort. However, their use carries certain risks, including sedative-related adverse effects and longer recovery times. The primary investigational focus of this trial is whether engaging patients with VR-powered distractions could reduce their reliance on these agents while maintaining effective analgesia and overall procedural comfort.
Virtual reality technology enables immersive audiovisual stimulation, creating a distraction that may alleviate anxiety, reduce perceived pain, and enhance patient relaxation. Researchers hypothesize that this non-pharmacological intervention could effectively complement sedation or even modulate required doses, affecting both performance and safety outcomes.
Who should care?
This research trial could have implications for:
- Clinical teams seeking non-pharmacological adjuncts to sedative protocols.
- Medical device regulatory affairs professionals involved with VR technology implementations.
- Quality assurance teams ensuring patient safety and comfort during MAP procedures.
- Assistive technology developers interested in integrating VR solutions into fertility care.
As VR devices gain traction in healthcare, this trial’s findings may influence future regulatory submissions for similar technologies, particularly in Europe and regions governed by MDR Annex XIV guidance.
FAQ
1. What is the intended purpose of the VR device?
The VR device aims to distract patients during IVF/ICSI oocyte retrieval, potentially reducing the need for hypnotic agents like Propofol.
2. How are patients selected for participation in this trial?
The inclusion criteria have not been detailed in full, but the study targets individuals undergoing oocyte retrieval as part of MAP procedures.
3. Is VR distraction already widely used in other medical domains?
VR has been adopted in pain management and mental health interventions but remains investigational for procedural sedation purposes.
Conclusion
With recruitment underway, this randomised controlled trial provides a crucial opportunity to evaluate innovative approaches like VR-assisted interventions in fertility care. Any findings that show reduced reliance on hypnotic agents could signal a shift in MAP sedation protocols and influence future regulatory frameworks concerning VR medical devices.
Disclaimer
This content is provided for informational purposes only and does not constitute legal or regulatory advice. Professionals should consult applicable guidelines and standards before implementing any medical device solutions.
Further Information
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07190729?term=medical+device