Evaluation of the Impact of Stress on IVF Outcome

Last updated: August 20, 2024
Sponsor: Inception Fertility Research Institute, LLC
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Infertility

Treatment

N/A

Clinical Study ID

NCT05589571
INC-2022-002
  • Ages 25-40
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women age 25-40 years old

  • Planning to undergo their first IVF cycle with frozen embryo transfer at one of theparticipating 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 duringtheir IVF and FET cycle

  • Able to read and speak English

Exclusion

Exclusion Criteria:

  • Medical history of cardiac arrhythmias

  • History of cardiac surgery within a year of study enrollment

Study Design

Total Participants: 240
Study Start date:
February 01, 2023
Estimated Completion Date:
December 15, 2024

Study 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.

Connect with a study center

  • Arizona Reproductive Institute

    Tucson, Arizona 85718
    United States

    Site Not Available

  • Pacific Fertility Center

    San Francisco, California 94133
    United States

    Site Not Available

  • IVFMD

    Boca Raton, Florida 33428
    United States

    Site Not Available

  • Center for Reproductive Medicine

    Celebration, Florida 34747
    United States

    Site Not Available

  • IVFMD

    Cooper City, Florida 33024
    United States

    Site Not Available

  • IVFMD

    Jupiter, Florida 33458
    United States

    Site Not Available

  • IVFMD

    Miami, Florida 33143
    United States

    Site Not Available

  • IVFMD

    Naples, Florida 34108
    United States

    Site Not Available

  • IVFMD

    Viera, Florida 32940
    United States

    Site Not Available

  • Center for Reproductive Medicine

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Reproductive Biology Associates

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Reproductive Biology Associates

    Cumming, Georgia 30041
    United States

    Site Not Available

  • Reproductive Biology Associates

    Lawrenceville, Georgia 30046
    United States

    Site Not Available

  • Reproductive Biology Associates

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Advanced Fertility Center of Chicago

    Chicago, Illinois 60630
    United States

    Site Not Available

  • Advanced Fertility Center of Chicago

    Crystal Lake, Illinois 60014
    United States

    Site Not Available

  • Advanced Fertility Center of Chicago

    Downers Grove, Illinois 60515
    United States

    Site Not Available

  • Advanced Fertility Center of Chicago

    Gurnee, Illinois 60031
    United States

    Site Not Available

  • Indiana Fertility Institute

    Indianapolis, Indiana 46280
    United States

    Site Not Available

  • Main Line Fertility

    Bryn Mawr, Pennsylvania 19010
    United States

    Site Not Available

  • Main Line Fertility

    Havertown, Pennsylvania 19083
    United States

    Site Not Available

  • Main Line Fertility

    Paoli, Pennsylvania 19301
    United States

    Site Not Available

  • Main Line Fertility

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Main Line Fertility

    West Chester, Pennsylvania 19380
    United States

    Site Not Available

  • Tennessee Fertility Institute

    Franklin, Tennessee 37067
    United States

    Site Not Available

  • Tennessee Fertility Institute

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Aspire Fertility Austin

    Austin, Texas 78705
    United States

    Site Not Available

  • Aspire Houston Fertility Institute

    Beaumont, Texas 77706
    United States

    Site Not Available

  • Aspire Houston Fertility Institute

    Cypress, Texas 77433
    United States

    Site Not Available

  • Aspire Fertility Dallas

    Dallas, Texas 75001
    United States

    Site Not Available

  • Aspire Houston Fertility Institute - Main Street

    Houston, Texas 77030
    United States

    Site Not Available

  • Aspire Houston Fertility Institute - Medical Center

    Houston, Texas 77054
    United States

    Site Not Available

  • Aspire Houston Fertility Institute - Memorial City

    Houston, Texas 77024
    United States

    Site Not Available

  • Aspire Houston Fertility Institute - Piney Point

    Houston, Texas 77063
    United States

    Site Not Available

  • Aspire Houston Fertility Institute - Willowbrook

    Houston, Texas 77070
    United States

    Site Not Available

  • Aspire Houston Fertility Institute

    Katy, Texas 77494
    United States

    Site Not Available

  • Aspire Houston Fertility Institute

    Kingwood, Texas 77339
    United States

    Site Not Available

  • Aspire Fertility McAllen

    McAllen, Texas 78504
    United States

    Site Not Available

  • Aspire Houston Fertility Institute

    Pearland, Texas 77584
    United States

    Site Not Available

  • Aspire Fertility San Antonio - Medical Center

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Aspire Fertility San Antonio - Sonterra

    San Antonio, Texas 78258
    United States

    Site Not Available

  • Aspire Houston Fertility Institute

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Aspire Houston Fertility Institute

    The Woodlands, Texas 77385
    United States

    Site Not Available

  • Aspire Houston Fertility Institute

    Webster, Texas 77598
    United States

    Site Not Available

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