Evaluation of the Impact of Stress on IVF Outcome

July 16, 2025 updated by: Inception Fertility Research Institute, LLC

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Boca Raton, Florida, United States, 33428
        • IVFMD
      • Celebration, Florida, United States, 34747
        • Center for Reproductive Medicine
      • Cooper City, Florida, United States, 33024
        • IVFMD
      • Jupiter, Florida, United States, 33458
        • IVFMD
      • Miami, Florida, United States, 33143
        • IVFMD
      • Naples, Florida, United States, 34108
        • IVFMD
      • Viera, Florida, United States, 32940
        • IVFMD
      • Winter Park, Florida, United States, 32789
        • Center for Reproductive Medicine
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Reproductive Biology Associates
      • Atlanta, Georgia, United States, 30309
        • Reproductive Biology Associates
      • Cumming, Georgia, United States, 30041
        • Reproductive Biology Associates
      • Lawrenceville, Georgia, United States, 30046
        • Reproductive Biology Associates
      • Marietta, Georgia, United States, 30060
        • Reproductive Biology Associates
    • Illinois
      • Chicago, Illinois, United States, 60630
        • Advanced Fertility Center of Chicago
      • Crystal Lake, Illinois, United States, 60014
        • Advanced Fertility Center of Chicago
      • Downers Grove, Illinois, United States, 60515
        • Advanced Fertility Center of Chicago
      • Gurnee, Illinois, United States, 60031
        • Advanced Fertility Center of Chicago
    • Indiana
      • Indianapolis, Indiana, United States, 46280
        • Indiana Fertility Institute
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Main Line Fertility
      • Havertown, Pennsylvania, United States, 19083
        • Main Line Fertility
      • Paoli, Pennsylvania, United States, 19301
        • Main Line Fertility
      • Philadelphia, Pennsylvania, United States, 19107
        • Main Line Fertility
      • West Chester, Pennsylvania, United States, 19380
        • Main Line Fertility
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Tennessee Fertility Institute
      • Nashville, Tennessee, United States, 37203
        • Tennessee Fertility Institute
    • Texas
      • Austin, Texas, United States, 78705
        • Aspire Fertility Austin
      • Beaumont, Texas, United States, 77706
        • Aspire Houston Fertility Institute
      • Cypress, Texas, United States, 77433
        • Aspire Houston Fertility Institute
      • Dallas, Texas, United States, 75001
        • Aspire Fertility Dallas
      • Houston, Texas, United States, 77024
        • Aspire Houston Fertility Institute - Memorial City
      • Houston, Texas, United States, 77030
        • Aspire Houston Fertility Institute - Main Street
      • Houston, Texas, United States, 77054
        • Aspire Houston Fertility Institute - Medical Center
      • Houston, Texas, United States, 77063
        • Aspire Houston Fertility Institute - Piney Point
      • Houston, Texas, United States, 77070
        • Aspire Houston Fertility Institute - Willowbrook
      • Katy, Texas, United States, 77494
        • Aspire Houston Fertility Institute
      • Kingwood, Texas, United States, 77339
        • Aspire Houston Fertility Institute
      • McAllen, Texas, United States, 78504
        • Aspire Fertility McAllen
      • Pearland, Texas, United States, 77584
        • Aspire Houston Fertility Institute
      • San Antonio, Texas, United States, 78229
        • Aspire Fertility San Antonio - Medical Center
      • San Antonio, Texas, United States, 78258
        • Aspire Fertility San Antonio - Sonterra
      • Sugar Land, Texas, United States, 77479
        • Aspire Houston Fertility Institute
      • The Woodlands, Texas, United States, 77385
        • Aspire Houston Fertility Institute
      • Webster, Texas, United States, 77598
        • Aspire Houston Fertility Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women between age 25-40 years old who are scheduled to undergo their first IVF and frozen embryo transfer cycle at one of the participating fertility clinics.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inception Fertility Research Institute, LLC

Collaborators

OTO US Fertility LP

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Actual)

March 15, 2024

Study Completion (Actual)

April 1, 2025

Study Registration Dates

First Submitted

October 18, 2022

First Submitted That Met QC Criteria

October 18, 2022

First Posted (Actual)

October 21, 2022

Study Record Updates

Last Update Posted (Actual)

July 20, 2025

Last Update Submitted That Met QC Criteria

July 16, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INC-2022-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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