Evaluation of the Impact of Stress on IVF Outcome

NCT ID: NCT05589571

Last Updated: 2025-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2025-04-01

Brief Summary

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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

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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

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Stress, Physiological Infertility Stress, Psychological

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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OTO US Fertility LP

UNKNOWN

Sponsor Role collaborator

Inception Fertility Research Institute, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alice Domar, PhD

Role: PRINCIPAL_INVESTIGATOR

Inception Fertility Research Institute, LLC

Locations

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IVFMD

Boca Raton, Florida, United States

Site Status

Center for Reproductive Medicine

Celebration, Florida, United States

Site Status

IVFMD

Cooper City, Florida, United States

Site Status

IVFMD

Jupiter, Florida, United States

Site Status

IVFMD

Miami, Florida, United States

Site Status

IVFMD

Naples, Florida, United States

Site Status

IVFMD

Viera, Florida, United States

Site Status

Center for Reproductive Medicine

Winter Park, Florida, United States

Site Status

Reproductive Biology Associates

Atlanta, Georgia, United States

Site Status

Reproductive Biology Associates

Atlanta, Georgia, United States

Site Status

Reproductive Biology Associates

Cumming, Georgia, United States

Site Status

Reproductive Biology Associates

Lawrenceville, Georgia, United States

Site Status

Reproductive Biology Associates

Marietta, Georgia, United States

Site Status

Advanced Fertility Center of Chicago

Chicago, Illinois, United States

Site Status

Advanced Fertility Center of Chicago

Crystal Lake, Illinois, United States

Site Status

Advanced Fertility Center of Chicago

Downers Grove, Illinois, United States

Site Status

Advanced Fertility Center of Chicago

Gurnee, Illinois, United States

Site Status

Indiana Fertility Institute

Indianapolis, Indiana, United States

Site Status

Main Line Fertility

Bryn Mawr, Pennsylvania, United States

Site Status

Main Line Fertility

Havertown, Pennsylvania, United States

Site Status

Main Line Fertility

Paoli, Pennsylvania, United States

Site Status

Main Line Fertility

Philadelphia, Pennsylvania, United States

Site Status

Main Line Fertility

West Chester, Pennsylvania, United States

Site Status

Tennessee Fertility Institute

Franklin, Tennessee, United States

Site Status

Tennessee Fertility Institute

Nashville, Tennessee, United States

Site Status

Aspire Fertility Austin

Austin, Texas, United States

Site Status

Aspire Houston Fertility Institute

Beaumont, Texas, United States

Site Status

Aspire Houston Fertility Institute

Cypress, Texas, United States

Site Status

Aspire Fertility Dallas

Dallas, Texas, United States

Site Status

Aspire Houston Fertility Institute - Memorial City

Houston, Texas, United States

Site Status

Aspire Houston Fertility Institute - Main Street

Houston, Texas, United States

Site Status

Aspire Houston Fertility Institute - Medical Center

Houston, Texas, United States

Site Status

Aspire Houston Fertility Institute - Piney Point

Houston, Texas, United States

Site Status

Aspire Houston Fertility Institute - Willowbrook

Houston, Texas, United States

Site Status

Aspire Houston Fertility Institute

Katy, Texas, United States

Site Status

Aspire Houston Fertility Institute

Kingwood, Texas, United States

Site Status

Aspire Fertility McAllen

McAllen, Texas, United States

Site Status

Aspire Houston Fertility Institute

Pearland, Texas, United States

Site Status

Aspire Fertility San Antonio - Medical Center

San Antonio, Texas, United States

Site Status

Aspire Fertility San Antonio - Sonterra

San Antonio, Texas, United States

Site Status

Aspire Houston Fertility Institute

Sugar Land, Texas, United States

Site Status

Aspire Houston Fertility Institute

The Woodlands, Texas, United States

Site Status

Aspire Houston Fertility Institute

Webster, Texas, United States

Site Status

Countries

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United States

Related Links

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http://fertilitystudies.com/oto/

Inception Network Fertility Studies - OTO

Other Identifiers

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INC-2022-002

Identifier Type: -

Identifier Source: org_study_id

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