Virtual Reality Use in Assisted Reproductive Technology

NCT04394962 | Completed

• 1 other identifier: CL1E
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

The study will examine the effect of exposure to virtual reality on stress levels and pregnancy rates, in infertile women undergoing in vitro fertilization embryo transfer

Conditions

IVF Outcomes; Stress Levels

Keywords

Virtual reality; In vitro fertilization; Embryo transfer

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate (CPR)

  The difference in CPR (determined by sonographic evidence of a gestational sac and fetal heart rate at 6 weeks' gestation by transvaginal ultrasound) between the study and the control group. An increase of 15% in the clinical pregnancy rate in the study group will be considered as significant.

  Assessed 4 weeks after ET (= 6 weeks of gestation)

Secondary Outcomes (3)

• Stress levels - STAI questionnaires

  Questionnaires will be filled out in 3 different time points during the study: 1) Day 1 of recruitment, before beginning the medications for endometrial preparation 2) ET day, 30-60 minutes before ET 3) ET day, 5-10 minutes after ET procedure

• Salivary alpha amylase (SAA) levels

  Samples will be collected in 3 different time points during the study: 1) Day 1 of recruitment, before beginning the medications for endometrial preparation 2) ET day, 30-60 minutes before ET 3) ET day, 5-10 minutes after ET procedure

• Sympathetic autonomous nervous system expressions

  Measurements will be taken in 3 different time points during the study: 1) Day 1 of recruitment, before beginning the medications for endometrial preparation 2) 30-60 minutes before ET 3) ET day, 5-10 minutes after ET procedure

Study Arms (2)

Control group

NO INTERVENTION

Patients who will be randomized to the control group will be waiting for the ET procedure without any intervention and without any deviation from the standard of care

Study group

EXPERIMENTAL

Exposure to virtual reality environment exposure

Device: Virtual reality

Interventions

Virtual reality DEVICE

Patients randomized to the study group, will be provided with the VR headset and sensors. The VR exposure will take place before the ET procedure, during their routine pre-transfer waiting period, in a private room. The patient will be able to choose between three different calming VR environments (3 scenes: beach sunset, palm tree patio or redwood forest) and will be exposed to the chosen VR environment for a continuous duration of 15-30 minutes. The VR exposure will be passive, and the patient can control her observation inside the environment by herself, simply by moving her head. During this period, at any time and for any reason, the patient can discontinue the use of the VR session simply by self-removing the helmet

Also known as: "Oculus Rift" system, Immersive environment

Study group

Eligibility Criteria

• Age: 21 Years - 54 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• year-old female patients, if using own ovum. Patients above this age range may be approached for study if using a donated ovum, as long as "egg age" (age of donor at ovum pick up) falls in 21-45 age range.
• Undergoing frozen ET procedures, and approached for study on "Day 2 - Day 4" of ET transfer cycle.
• Ability to provide written consent to use VR technology before the ET procedure

You may not qualify if:

• Contraindication to use VR technology (Epilepsy/previous seizure, claustrophobia, current migraine, heart disease, visual and/or auditory deficits/use of medical devices such as cardiac pacemaker or hearing aids)
• Anxiety disorder and/or Regular use of anti-anxiety medications
• Major uterine anomalies and/or uterine fibroids distorting the cavity

Sponsors & Collaborators

• Dr cliff Librach: lead

Study Sites (1)

Create Fertility Centre

Toronto, Ontario, M5G 1N8, Canada

Location

Related Publications (32)

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Study Officials

• Clifford Librach, MD

  CReATe Fertility Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The Physician performing the embryo transfer will be blinded to the patient's group randomization
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clifford Librach, MD, FRCS(C), FACOG(REI), Director of the Create Fertility Centre, Professor, Department of Obstetrics and Gynecology, University of Toronto

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 20, 2020
• Study Start: May 31, 2019
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

CA (1)