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Completed

NCT Number: NCT05589571

Evaluation of the Impact of Stress on IVF 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.

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Key information

Age range

25 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

IVFMD, Boca Raton, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Physiological Stress

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Inception Fertility Research Institute, LLC

Industry

Collaborators

  • OTO US Fertility LP

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Oct 21, 2022
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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