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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05589571

Enrollment

240

Registered

2022-10-21

Start date

2023-02-01

Completion date

2025-04-01

Last updated

2025-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Stress, Physiological, Stress, Psychological

Keywords

IVF, In-vitro fertilization, OTO, Inception, Stress, Omegawave, Infertility, FET, Frozen embryo transfer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

25 Years to 40 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results