Clinical trial NCT05589571: Evaluation of the Impact of Stress on IVF Outcome
Official title: An Evaluation of the Relationship Between Physiological Parameters of Stress and In Vitro Fertilization Outcome
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Stress, Physiological
Infertility
Stress, Psychological
Keywords: IVF
In-vitro fertilization
OTO
Inception
Stress
Omegawave
Infertility
FET
Frozen embryo transfer
Lead sponsor: Inception Fertility Research Institute, LLC
Sponsor class: INDUSTRY
Collaborators: name: OTO US Fertility LP
First posted: 2022-10-21
Enrollment: 240
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Physiological Stress
timeFrame: 7 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: IVFMD
state: Florida
city: Celebration
country: United States
facility: Center for Reproductive Medicine
state: Florida
city: Cooper City
country: United States
facility: IVFMD
state: Florida
city: Jupiter
country: United States
facility: IVFMD
state: Florida
city: Miami
country: United States
facility: IVFMD
state: Florida
city: Naples
country: United States
facility: IVFMD
state: Florida
city: Viera
country: United States
facility: IVFMD
state: Florida
city: Winter Park
country: United States
facility: Center for Reproductive Medicine
state: Florida
city: Atlanta
country: United States
facility: Reproductive Biology Associates
state: Georgia
city: Atlanta
country: United States
facility: Reproductive Biology Associates
state: Georgia
city: Cumming
country: United States
facility: Reproductive Biology Associates
state: Georgia
city: Lawrenceville
country: United States
facility: Reproductive Biology Associates
state: Georgia
city: Marietta
country: United States
facility: Reproductive Biology Associates
state: Georgia
city: Chicago
country: United States
facility: Advanced Fertility Center of Chicago
state: Illinois
city: Crystal Lake
country: United States
facility: Advanced Fertility Center of Chicago
state: Illinois
city: Downers Grove
country: United States
facility: Advanced Fertility Center of Chicago
state: Illinois
city: Gurnee
country: United States
facility: Advanced Fertility Center of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Fertility Institute
state: Indiana
city: Bryn Mawr
country: United States
facility: Main Line Fertility
state: Pennsylvania
city: Havertown
country: United States
facility: Main Line Fertility
state: Pennsylvania
city: Paoli
country: United States
facility: Main Line Fertility
state: Pennsylvania
city: Philadelphia
country: United States
facility: Main Line Fertility
state: Pennsylvania
city: West Chester
country: United States
facility: Main Line Fertility
state: Pennsylvania
city: Franklin
country: United States
facility: Tennessee Fertility Institute
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Fertility Institute
state: Tennessee
city: Austin
country: United States
facility: Aspire Fertility Austin
state: Texas
city: Beaumont
country: United States
facility: Aspire Houston Fertility Institute
state: Texas
city: Cypress
country: United States
facility: Aspire Houston Fertility Institute
state: Texas
city: Dallas
country: United States
facility: Aspire Fertility Dallas
state: Texas
city: Houston
country: United States
facility: Aspire Houston Fertility Institute - Memorial City
state: Texas
city: Houston
country: United States
facility: Aspire Houston Fertility Institute - Main Street
state: Texas
city: Houston
country: United States
facility: Aspire Houston Fertility Institute - Medical Center
state: Texas
city: Houston
country: United States
facility: Aspire Houston Fertility Institute - Piney Point
state: Texas
city: Houston
country: United States
facility: Aspire Houston Fertility Institute - Willowbrook
state: Texas
city: Katy
country: United States
facility: Aspire Houston Fertility Institute
state: Texas
city: Kingwood
country: United States
facility: Aspire Houston Fertility Institute
state: Texas
city: McAllen
country: United States
facility: Aspire Fertility McAllen
state: Texas
city: Pearland
country: United States
facility: Aspire Houston Fertility Institute
state: Texas
city: San Antonio
country: United States
facility: Aspire Fertility San Antonio - Medical Center
state: Texas
city: San Antonio
country: United States
facility: Aspire Fertility San Antonio - Sonterra
state: Texas
city: Sugar Land
country: United States
facility: Aspire Houston Fertility Institute
state: Texas
city: The Woodlands
country: United States
facility: Aspire Houston Fertility Institute
state: Texas
city: Webster
country: United States
facility: Aspire Houston Fertility Institute
state: Texas
Study officials:
affiliation: Inception Fertility Research Institute, LLC
name: Alice Domar, PhD
role: PRINCIPAL_INVESTIGATOR
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citation: Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
citation: Schmidt L. Infertility and assisted reproduction in Denmark. Epidemiology and psychosocial consequences. Dan Med Bull. 2006 Nov;53(4):390-417.