Evaluation of the Impact of Stress on IVF Outcome
An Evaluation of the Relationship Between Physiological Parameters of Stress and In Vitro Fertilization Outcome
1 other identifier
observational
240
1 country
43
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2023
Typical duration for all trials
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2022
CompletedFirst Posted
Study publicly available on registry
October 21, 2022
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2025
CompletedJuly 20, 2025
July 1, 2025
1.1 years
October 18, 2022
July 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Physiological Stress
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
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Medical history of cardiac arrhythmias
- History of cardiac surgery within a year of study enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Inception Fertility Research Institute, LLClead
- OTO US Fertility LPcollaborator
Study Sites (43)
IVFMD
Boca Raton, Florida, 33428, United States
Center for Reproductive Medicine
Celebration, Florida, 34747, United States
IVFMD
Cooper City, Florida, 33024, United States
IVFMD
Jupiter, Florida, 33458, United States
IVFMD
Miami, Florida, 33143, United States
IVFMD
Naples, Florida, 34108, United States
IVFMD
Viera, Florida, 32940, United States
Center for Reproductive Medicine
Winter Park, Florida, 32789, United States
Reproductive Biology Associates
Atlanta, Georgia, 30309, United States
Reproductive Biology Associates
Atlanta, Georgia, 30342, United States
Reproductive Biology Associates
Cumming, Georgia, 30041, United States
Reproductive Biology Associates
Lawrenceville, Georgia, 30046, United States
Reproductive Biology Associates
Marietta, Georgia, 30060, United States
Advanced Fertility Center of Chicago
Chicago, Illinois, 60630, United States
Advanced Fertility Center of Chicago
Crystal Lake, Illinois, 60014, United States
Advanced Fertility Center of Chicago
Downers Grove, Illinois, 60515, United States
Advanced Fertility Center of Chicago
Gurnee, Illinois, 60031, United States
Indiana Fertility Institute
Indianapolis, Indiana, 46280, United States
Main Line Fertility
Bryn Mawr, Pennsylvania, 19010, United States
Main Line Fertility
Havertown, Pennsylvania, 19083, United States
Main Line Fertility
Paoli, Pennsylvania, 19301, United States
Main Line Fertility
Philadelphia, Pennsylvania, 19107, United States
Main Line Fertility
West Chester, Pennsylvania, 19380, United States
Tennessee Fertility Institute
Franklin, Tennessee, 37067, United States
Tennessee Fertility Institute
Nashville, Tennessee, 37203, United States
Aspire Fertility Austin
Austin, Texas, 78705, United States
Aspire Houston Fertility Institute
Beaumont, Texas, 77706, United States
Aspire Houston Fertility Institute
Cypress, Texas, 77433, United States
Aspire Fertility Dallas
Dallas, Texas, 75001, United States
Aspire Houston Fertility Institute - Memorial City
Houston, Texas, 77024, United States
Aspire Houston Fertility Institute - Main Street
Houston, Texas, 77030, United States
Aspire Houston Fertility Institute - Medical Center
Houston, Texas, 77054, United States
Aspire Houston Fertility Institute - Piney Point
Houston, Texas, 77063, United States
Aspire Houston Fertility Institute - Willowbrook
Houston, Texas, 77070, United States
Aspire Houston Fertility Institute
Katy, Texas, 77494, United States
Aspire Houston Fertility Institute
Kingwood, Texas, 77339, United States
Aspire Fertility McAllen
McAllen, Texas, 78504, United States
Aspire Houston Fertility Institute
Pearland, Texas, 77584, United States
Aspire Fertility San Antonio - Medical Center
San Antonio, Texas, 78229, United States
Aspire Fertility San Antonio - Sonterra
San Antonio, Texas, 78258, United States
Aspire Houston Fertility Institute
Sugar Land, Texas, 77479, United States
Aspire Houston Fertility Institute
The Woodlands, Texas, 77385, United States
Aspire Houston Fertility Institute
Webster, Texas, 77598, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alice Domar, PhD
Inception Fertility Research Institute, LLC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2022
First Posted
October 21, 2022
Study Start
February 1, 2023
Primary Completion
March 15, 2024
Study Completion
April 1, 2025
Last Updated
July 20, 2025
Record last verified: 2025-07