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Virtual Reality Use in Assisted Reproductive Technology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04394962
Recruitment Status : Suspended (Due to COVID-19 situation)
First Posted : May 20, 2020
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
Dr cliff Librach, Create Fertility Center

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

Condition or disease Intervention/treatment Phase
IVF Outcomes Stress Levels Device: Virtual reality Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Masking Description: The Physician performing the embryo transfer will be blinded to the patient's group randomization
Primary Purpose: Other
Official Title: The Use of Virtual Reality Technology in Infertile Women Undergoing in Vitro Fertilization-embryo Transfer: A Randomized Controlled Trial
Actual Study Start Date : May 31, 2019
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : March 30, 2021

Arm Intervention/treatment
No Intervention: Control group
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
Experimental: Study group
Exposure to virtual reality environment exposure
Device: Virtual reality
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
Other Names:
  • "Oculus Rift" system
  • Immersive environment




Primary Outcome Measures :
  1. Clinical pregnancy rate (CPR) [ Time Frame: Assessed 4 weeks after ET (= 6 weeks of gestation) ]
    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.


Secondary Outcome Measures :
  1. Stress levels - STAI questionnaires [ Time Frame: 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 ]
    Will be assessed using the STAI questionnaire (scored 20-80 points). We are expecting a 25% decrease in the STAI scores in the study group to be significant, based on clinical experience with similar patient population

  2. Salivary alpha amylase (SAA) levels [ Time Frame: 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 ]
    Salivary samples will be collected and analyzed. A 30% decrease in the SAA levels in the study group vs control will be considered significant, based on a previous study

  3. Sympathetic autonomous nervous system expressions [ Time Frame: 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 ]
    Heart rate & blood pressure measurements. These 2 sympathetic nervous system variables were selected as physical parameters which may indicate anxiety. A significant change between the groups will be based on clinical experience with similar patient populations. An estimated one-third (33%) of the patients would experience elevated blood pressure and/or heart rate readings in the moderate-to-severe range during the standard procedure. VR exposure therapy is expected to reduce this proportion to 20%.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 54 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 21-45-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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04394962


Locations
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Canada, Ontario
Create Fertility Centre
Toronto, Ontario, Canada, M5G 1N8
Sponsors and Collaborators
Dr cliff Librach
Publications:
Spielberger CD. Manual for the State-Trait Anxiety Inventory: STAI (form Y). Palo Alto, CA: Consulting Psychologists Press. 1983.

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Responsible Party: Dr cliff Librach, Clifford Librach, MD, FRCS(C), FACOG(REI), Director of the Create Fertility Centre, Professor, Department of Obstetrics and Gynecology, University of Toronto, Create Fertility Center
ClinicalTrials.gov Identifier: NCT04394962    
Other Study ID Numbers: CL1E
First Posted: May 20, 2020    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr cliff Librach, Create Fertility Center:
Virtual reality
In vitro fertilization
Embryo transfer