Stress, PhysiologicalNCT05589571
Evaluation of the Impact of Stress on IVF Outcome
An observational study of Stress, Physiological and Infertility, run by Inception Fertility Research Institute, LLC at 43 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Stress, Physiological, Infertility, Stress, Psychological
- How many people
- 240 participants
- Where
- 43 sitesUnited States
- Study dates
- 1 Feb 2023to 1 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- Medical history of cardiac arrhythmias
- History of cardiac surgery within a year of study enrollment
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
United States43 sites
Reproductive Biology Associates
Atlanta, Georgia, 30309
Reproductive Biology Associates
Atlanta, Georgia, 30342
Aspire Fertility Austin
Austin, Texas, 78705
Aspire Houston Fertility Institute
Beaumont, Texas, 77706
IVFMD
Boca Raton, Florida, 33428
Main Line Fertility
Bryn Mawr, Pennsylvania, 19010
Center for Reproductive Medicine
Celebration, Florida, 34747
Advanced Fertility Center of Chicago
Chicago, Illinois, 60630
IVFMD
Cooper City, Florida, 33024
Advanced Fertility Center of Chicago
Crystal Lake, Illinois, 60014
Reproductive Biology Associates
Cumming, Georgia, 30041
Aspire Houston Fertility Institute
Cypress, Texas, 77433
Aspire Fertility Dallas
Dallas, Texas, 75001
Advanced Fertility Center of Chicago
Downers Grove, Illinois, 60515
Tennessee Fertility Institute
Franklin, Tennessee, 37067
Advanced Fertility Center of Chicago
Gurnee, Illinois, 60031
Main Line Fertility
Havertown, Pennsylvania, 19083
Aspire Houston Fertility Institute - Memorial City
Houston, Texas, 77024
Aspire Houston Fertility Institute - Main Street
Houston, Texas, 77030
Aspire Houston Fertility Institute - Medical Center
Houston, Texas, 77054
Aspire Houston Fertility Institute - Piney Point
Houston, Texas, 77063
Aspire Houston Fertility Institute - Willowbrook
Houston, Texas, 77070
Indiana Fertility Institute
Indianapolis, Indiana, 46280
IVFMD
Jupiter, Florida, 33458
Aspire Houston Fertility Institute
Katy, Texas, 77494
Aspire Houston Fertility Institute
Kingwood, Texas, 77339
Reproductive Biology Associates
Lawrenceville, Georgia, 30046
Reproductive Biology Associates
Marietta, Georgia, 30060
Aspire Fertility McAllen
McAllen, Texas, 78504
IVFMD
Miami, Florida, 33143
IVFMD
Naples, Florida, 34108
Tennessee Fertility Institute
Nashville, Tennessee, 37203
Main Line Fertility
Paoli, Pennsylvania, 19301
Aspire Houston Fertility Institute
Pearland, Texas, 77584
Main Line Fertility
Philadelphia, Pennsylvania, 19107
Aspire Fertility San Antonio - Medical Center
San Antonio, Texas, 78229
Aspire Fertility San Antonio - Sonterra
San Antonio, Texas, 78258
Aspire Houston Fertility Institute
Sugar Land, Texas, 77479
Aspire Houston Fertility Institute
The Woodlands, Texas, 77385
IVFMD
Viera, Florida, 32940
Aspire Houston Fertility Institute
Webster, Texas, 77598
Main Line Fertility
West Chester, Pennsylvania, 19380
Center for Reproductive Medicine
Winter Park, Florida, 32789
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress, Physiological, Infertility, Stress, Psychological
- Keywords
- IVF, In-vitro fertilization, OTO, Inception, Stress, Omegawave, Infertility, FET, Frozen embryo transfer
- Medical subject headings
- Infertility, Stress, Psychological
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start1 Feb 2023
- Primary completion15 Mar 2024
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PhysiologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inception Fertility Research Institute, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- OTO US Fertility LP
- Responsible party
- Sponsor
- Investigators
- Alice Domar, PhD, Principal investigator, Inception Fertility Research Institute, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589571
- Sponsor's protocol ID
- INC-2022-002
- Status last verified
- Jul 2025
- First submitted
- 18 Oct 2022
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Relationship Between Physiological Parameters of Stress and In Vitro Fertilization Outcome
- ClinicalTrials.gov ID
- NCT05589571
- Acronym / sponsor ID
- INC-2022-002
- Conditions
- Stress, Physiological, Infertility, Stress, Psychological
- Keywords
- IVF, In-vitro fertilization, OTO, Inception, Stress, Omegawave, Infertility, FET
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Inception Fertility Research Institute, LLCIndustry (pharma, biotech, devices)
- Collaborators
- OTO US Fertility LP
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 21 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Medical history of cardiac arrhythmias
- History of cardiac surgery within a year of study enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Inception Network Fertility Studies - OTOLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice Domar, PhD principal investigator
Inception Fertility Research Institute, LLC
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress, Physiological and Infertility, run by Inception Fertility Research Institute, LLC at 43 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological Stress (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.