Virtual Reality for Acute Pain and Anxiety During Egg Retrieval for in Vitro Fertility Treatment

NCT05438238 | Unknown

• 1 other identifier: VR-OPU
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a comparison between the current standard practice of performing a transvaginal oocyte retrieval (TVOR) with paracervical block (PCB) and a relatively recently developed technology of virtual reality that is added to the above mentioned standard practice of TVOR + PCB. The aim of the study is to find out whether this newer technology has an advantage for the patient, in terms of anxiety and pain reduction or satisfaction.

Conditions

Infertility; In Vitro Fertilization; IVF; ART

Keywords

virtual reality; infertility; transvaginal oocyte retrieval; IVF, in vitro fertilization

Outcome Measures

Primary Outcomes (1)

• Difference in visual analog scale score for Pain

  change in pain experience, assessed using visual analog scale (VAS). VAS is a 100mm linear visual analog scale with 0 as no pain and 10.0 as the worst pain imaginable.

  1/ pre-procedure baseline 2/ immediately after the procedure and 3/ 5days after TVOR

Secondary Outcomes (1)

• Difference in visual analog scale score for anxiety

  1/ pre-procedure baseline 2/ immediately after the procedure and 3/ 5days after TVOR

Study Arms (2)

investigational group A

EXPERIMENTAL

during TVOR +PCB addition of Oncomfort, commercially available Virtual Reality headset, consisting of headphones with smartphone glasses - see oncomfort.com/en, CE approval conform IEC62366-1:2015, EN 62304:2006/Amd1:2015, EN 82304-1:2015, EN 82304-1:2016, ISO 13485:2016, EN ISO 14971:2019, EN 60601-1-2:2015

Device: Oncomfort

reference group

NO INTERVENTION

standard of care TVOR + PCB

Interventions

Oncomfort DEVICE

Virtual Reality

investigational group A

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Transvaginal oocyte retrieval requires controlled ovarian hyperstimulation of ovaries
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• female
• ≥18 and ≤ 40 years of age
• undergoing fertility treatments
• undergoing egg retrieval as part of in vitro fertilization treatment
• only first ≤ 3 IVF cycles.
• Bilateral ovarian follicular response (\>3 and \<30 follicles)

You may not qualify if:

• Hearing impairments and blindness
• Motion sickness
• Any known anatomical characteristics that may make performing the office procedure impossible.
• Patients undergoing a general anesthesia or conscious sedation
• lack of informed consent
• Chronic alcohol/drug abusers
• Transabdominal approach for retrieval
• Patients undergoing oocyte retrieval for fertility preservation before cancer or genotoxic treatment - oncofertility preservation
• allergy to medications used

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel CRG

Jette, Brussels Capital, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Christophe Blockeel, MD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valerie Schutyser, MD

CONTACT

+32 2 477 2676; dr.valerie.schutyser@gmail.com

Elsie Nulens

CONTACT

+32 2 477 2676; elsie.nulens@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a comparison between the current standard practice of performing an egg retrieval with paracervical block (PCB) and virtual reality that is added to the above mentioned standard practice of TVOR + PCB. The aim of the study is to find out whether this newer technology has an advantage for the patient, in terms of anxiety and pain reduction, by aid of questionnaires

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: June 29, 2022
• Study Start: February 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: May 18, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)