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Impact of Stress on IVF Outcome

Sponsor
Inception Fertility, LLC (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05589571
Collaborator
OTO US Fertility LP (Other)
240
Enrollment
39
Locations
10
Anticipated Duration (Months)
6.2
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 subject using the OTO device for the duration of one fresh IVF cycle, beginning on the first day of controlled ovarian stimulation and concluding on the day of the pregnancy test. Subjects will complete questionnaires related to perceived stress online at the beginning and the end of study participation. Subject's IVF cycle treatment and outcome data will be collected and analyzed in conjunction with the physiological data collected with the OTO device.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    240 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Determining the Relationship Between Physiological Parameters of Stress and In Vitro Fertilization Outcome
    Anticipated Study Start Date :
    Nov 1, 2022
    Anticipated Primary Completion Date :
    Jun 1, 2023
    Anticipated Study Completion Date :
    Sep 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Physiological Stress [5 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Women age 25-40 years old who are scheduled to undergo their first IVF cycle with fresh 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 cycle

    Exclusion Criteria:

    • Inability to read English

    • Medical history of cardiac arrhythmias

    • Cardiac surgery within a year of study enrollment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Reproductive Institute Tucson Arizona United States 85718
    2 Pacific Fertility Center San Francisco California United States 94133
    3 Center for Reproductive Medicine Celebration Florida United States 34747
    4 Center for Reproductive Medicine Winter Park Florida United States 32789
    5 Pathways Fertility Atlanta Georgia United States 30327
    6 Reproductive Biology Associates Atlanta Georgia United States 30342
    7 Reproductive Biology Associates Cumming Georgia United States 30041
    8 Reproductive Biology Associates Lawrenceville Georgia United States 30046
    9 Reproductive Biology Associates Marietta Georgia United States 30060
    10 Advanced Fertility Center of Chicago Chicago Illinois United States 60630
    11 Advanced Fertility Center of Chicago Crystal Lake Illinois United States 60014
    12 Advanced Fertility Center of Chicago Downers Grove Illinois United States 60515
    13 Advanced Fertility Center of Chicago Gurnee Illinois United States 60031
    14 Indiana Fertility Institute Indianapolis Indiana United States 46280
    15 Main Line Fertility Bryn Mawr Pennsylvania United States 19010
    16 Main Line Fertility Havertown Pennsylvania United States 19083
    17 Main Line Fertility Paoli Pennsylvania United States 19301
    18 Main Line Fertility Philadelphia Pennsylvania United States 19107
    19 Main Line Fertility West Chester Pennsylvania United States 19380
    20 Tennessee Fertility Institute Franklin Tennessee United States 37067
    21 Tennessee Fertility Institute Nashville Tennessee United States 37203
    22 Aspire Fertility Austin Austin Texas United States 78705
    23 Aspire Houston Fertility Institute Beaumont Texas United States 77706
    24 Aspire Houston Fertility Institute Cypress Texas United States 77433
    25 Aspire Fertility Dallas Dallas Texas United States 75001
    26 Aspire Houston Fertility Institute - Memorial City Houston Texas United States 77024
    27 Aspire Houston Fertility Institute - Main Street Houston Texas United States 77030
    28 Aspire Houston Fertility Institute - Medical Center Houston Texas United States 77054
    29 Aspire Houston Fertility Institute - Piney Point Houston Texas United States 77063
    30 Aspire Houston Fertility Institute - Willowbrook Houston Texas United States 77070
    31 Aspire Houston Fertility Institute Katy Texas United States 77494
    32 Aspire Houston Fertility Institute Kingwood Texas United States 77339
    33 Aspire Fertility McAllen McAllen Texas United States 78504
    34 Aspire Houston Fertility Institute Pearland Texas United States 77584
    35 Aspire Fertility San Antonio - Medical Center San Antonio Texas United States 78229
    36 Aspire Fertility San Antonio - Sonterra San Antonio Texas United States 78258
    37 Aspire Houston Fertility Institute Sugar Land Texas United States 77479
    38 Aspire Houston Fertility Institute The Woodlands Texas United States 77385
    39 Aspire Houston Fertility Institute Webster Texas United States 77598

    Sponsors and Collaborators

    • Inception Fertility, LLC
    • OTO US Fertility LP

    Investigators

    • Principal Investigator: Alice Domar, PhD, Inception Fertility, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Alice Domar, Chief Compassion Officer, Inception Fertility, LLC
    ClinicalTrials.gov Identifier:
    NCT05589571
    Other Study ID Numbers:
    • INC-2022-002
    First Posted:
    Oct 21, 2022
    Last Update Posted:
    Oct 21, 2022
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Alice Domar, Chief Compassion Officer, Inception Fertility, LLC
    IVF
    In-vitro fertilization
    OTO
    Inception
    Stress
    Omegawave
    Infertility
    Additional relevant MeSH terms:
    Infertility
    Stress, Psychological

    Study Results

    No Results Posted as of Oct 21, 2022