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An Evaluation of the Relationship Between Physiological Parameters of Stress and In Vitro Fertilization Outcome
The purpose of this study is to determine if physiological measures of stress, measured by the non-invasive OTO device, are significantly correlated with IVF outcome.
The OTO device is a wearable device that utilizes multiple methods of electrophysiology to identify the impact of stress on humans. The device consists of the OTO sensor, a belt with two electrode pads worn around the chest, one electrode placed on the thenar of the dominant hand and one electrode placed on the forehead; the sensor pairs with the OTO App via Bluetooth. It tracks 54 physiological properties including temperature, HRV, amplitude frequency analysis (AFA) of ECG and DC potential. This data is analyzed by the proprietary OTO Expert System which creates the overall conclusions on levels of stress, functional reserves, adaptive capacity and level of readiness to additional stressors. Physiological data will be collected from the study participant using the OTO device for the duration of one IVF and frozen embryo transfer (FET) cycle. Study participants will complete questionnaires online related to perceived stress at the beginning and the end of study participation. Study participant's IVF cycle treatment and outcome data will be collected and analyzed in conjunction with the physiological data collected with the OTO device.
Age
25 - 40 years
Sex
FEMALE
Healthy Volunteers
No
IVFMD
Boca Raton, Florida, United States
Center for Reproductive Medicine
Celebration, Florida, United States
IVFMD
Cooper City, Florida, United States
IVFMD
Jupiter, Florida, United States
IVFMD
Miami, Florida, United States
IVFMD
Naples, Florida, United States
IVFMD
Viera, Florida, United States
Center for Reproductive Medicine
Winter Park, Florida, United States
Reproductive Biology Associates
Atlanta, Georgia, United States
Reproductive Biology Associates
Atlanta, Georgia, United States
Start Date
February 1, 2023
Primary Completion Date
March 15, 2024
Completion Date
April 1, 2025
Last Updated
July 20, 2025
240
ACTUAL participants
Lead Sponsor
Inception Fertility Research Institute, LLC
Collaborators
NCT06826365
NCT07153367
Data Source & Attribution
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