NCT05589571

Evaluation of the Impact of Stress on IVF Outcome

An Evaluation of the Relationship Between Physiological Parameters of Stress and In Vitro Fertilization Outcome

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 240 (actual)
• Sponsor: Inception Fertility Research Institute, LLC · Industry
• Sex: Female
• Age: 25 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Stress, Physiological
• Infertility
• Stress, Psychological

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-03-15
• Completion: 2025-04-01
• First posted: 2022-10-21
• Last updated: 2025-07-20

Locations

43 sites across 1 country: United States