Evaluation of the Impact of Stress on IVF Outcome

Active, not recruiting

• Conditions: Stress, Physiological; Stress, Psychological; Infertility

• Registration Number: NCT05589571
• Lead Sponsor: Inception Fertility Research Institute, LLC

Brief 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.

Study Timeline

• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-10-18
• Study First Posted: 2022-10-21
• Study Start: 2023-02-01
• Primary Completion: 2024-03-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

• Women age 25-40 years old
• Planning to undergo their first IVF cycle with frozen embryo transfer at one of the participating fertility clinics
• Have access to the internet and own a smartphone
• Ability and willingness to wear the OTO device for a few minutes each morning during their IVF and FET cycle
• Able to read and speak English

Exclusion Criteria

• Medical history of cardiac arrhythmias
• History of cardiac surgery within a year of study enrollment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physiological Stress	7 weeks	Physiological stress will be measured using the non-invasive OTO device, which tracks 54 physiological properties including temperature, hear rate variability (HRV), amplitude frequency analysis (AFA) of electrocardiogram (ECG) and direct current (DC) potential.

Trial Locations

Locations (18)

IVFMD; 🇺🇸 Viera, Florida, United States

Center for Reproductive Medicine; 🇺🇸 Winter Park, Florida, United States

Reproductive Biology Associates; 🇺🇸 Marietta, Georgia, United States

Advanced Fertility Center of Chicago; 🇺🇸 Gurnee, Illinois, United States

Indiana Fertility Institute; 🇺🇸 Indianapolis, Indiana, United States

Main Line Fertility; 🇺🇸 West Chester, Pennsylvania, United States

Tennessee Fertility Institute; 🇺🇸 Nashville, Tennessee, United States

Aspire Fertility Austin; 🇺🇸 Austin, Texas, United States

Aspire Houston Fertility Institute; 🇺🇸 Webster, Texas, United States

Aspire Fertility Dallas; 🇺🇸 Dallas, Texas, United States

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