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NCT05589571 Clinical Trial

Evaluation of the Impact of Stress on IVF Outcome

Infertility Clinical Trial

Official title:
An Evaluation of the Relationship Between Physiological Parameters of Stress and In Vitro Fertilization Outcome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05589571
Other study ID # INC-2022-002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2023
Est. completion date March 15, 2024

Study information
Verified date April 2024
Source Inception Fertility, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 240
Est. completion date March 15, 2024
Est. primary completion date March 15, 2024
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 40 Years
Eligibility - 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 - No medical history of cardiac arrhythmias - No cardiac surgery within a year of study enrollment

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Reproductive Biology Associates Atlanta Georgia
United States Reproductive Biology Associates Atlanta Georgia
United States Aspire Fertility Austin Austin Texas
United States Aspire Houston Fertility Institute Beaumont Texas
United States IVFMD Boca Raton Florida
United States Main Line Fertility Bryn Mawr Pennsylvania
United States Center for Reproductive Medicine Celebration Florida
United States Advanced Fertility Center of Chicago Chicago Illinois
United States IVFMD Cooper City Florida
United States Advanced Fertility Center of Chicago Crystal Lake Illinois
United States Reproductive Biology Associates Cumming Georgia
United States Aspire Houston Fertility Institute Cypress Texas
United States Aspire Fertility Dallas Dallas Texas
United States Advanced Fertility Center of Chicago Downers Grove Illinois
United States Tennessee Fertility Institute Franklin Tennessee
United States Advanced Fertility Center of Chicago Gurnee Illinois
United States Main Line Fertility Havertown Pennsylvania
United States Aspire Houston Fertility Institute - Main Street Houston Texas
United States Aspire Houston Fertility Institute - Medical Center Houston Texas
United States Aspire Houston Fertility Institute - Memorial City Houston Texas
United States Aspire Houston Fertility Institute - Piney Point Houston Texas
United States Aspire Houston Fertility Institute - Willowbrook Houston Texas
United States Indiana Fertility Institute Indianapolis Indiana
United States IVFMD Jupiter Florida
United States Aspire Houston Fertility Institute Katy Texas
United States Aspire Houston Fertility Institute Kingwood Texas
United States Reproductive Biology Associates Lawrenceville Georgia
United States Reproductive Biology Associates Marietta Georgia
United States Aspire Fertility McAllen McAllen Texas
United States IVFMD Miami Florida
United States IVFMD Naples Florida
United States Tennessee Fertility Institute Nashville Tennessee
United States Main Line Fertility Paoli Pennsylvania
United States Aspire Houston Fertility Institute Pearland Texas
United States Main Line Fertility Philadelphia Pennsylvania
United States Aspire Fertility San Antonio - Medical Center San Antonio Texas
United States Aspire Fertility San Antonio - Sonterra San Antonio Texas
United States Aspire Houston Fertility Institute Sugar Land Texas
United States Aspire Houston Fertility Institute The Woodlands Texas
United States IVFMD Viera Florida
United States Aspire Houston Fertility Institute Webster Texas
United States Main Line Fertility West Chester Pennsylvania
United States Center for Reproductive Medicine Winter Park Florida

Sponsors (2)
Lead Sponsor Collaborator
Inception Fertility, LLC OTO US Fertility LP

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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