Clinical Trials Logo
  1. Home
  2. Infertility
  3. NCT05589571
  4. Details
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
See also
  Status Clinical Trial Phase
Completed NCT03607409 - Role of Inhibin A as Biomarker for Ovarian Response for IVF Treatment
Recruiting NCT02312076 - GnRHa for Luteal Phase Support in Long GnRHa Protocol Cycles Phase 4
Terminated NCT02161861 - Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study N/A
Completed NCT03287479 - Comparison of a Semi-automated Closed Vitrification System (Gavi®) With a Manual Open Vitrification Sytem (Cryotop®) N/A
Terminated NCT03522350 - Randomized Trial Comparing EmbryoScope With EmbryoScope+. N/A
Completed NCT04496284 - Embryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen N/A
Completed NCT03623659 - pArtiaL zonA pelluciDa Removal by assisteD hatchINg of Blastocysts N/A
Completed NCT03895099 - New Ovarian Stimulation With Random Start, Use of Progestin Protocol for Oocyte Donors Phase 3
Active, not recruiting NCT04142112 - Randomized, Standard-Controlled, Study to Evaluate the Ohana IVF Sperm Preparation Kit, SPeRtility IVF Next Generation N/A
Completed NCT03152643 - Cumulative Live Birth Rates After Cleavage-stage Versus Blastocyst-stage Embryo Transfer N/A
Recruiting NCT03683771 - Assessment of Endometrial Pattern and Sub-endometrial Vascularity in ICSI Outcome
Recruiting NCT03161119 - Comparing Two Different Embryo Transfer Catheters N/A
Completed NCT04108039 - Micronized Progesterone vs Gonadotropin-releasing Hormone (GnRH) Antagonist in Freeze-all IVF Cycles. N/A
Completed NCT03678584 - Supplementing Intracytoplasmic Sperm Injection Handling Medium With Chaetoglobosin A ( ICSI-CA) N/A
Completed NCT03678610 - Handling Medium for ICSI With Ionomycin and Latrunculin A N/A
Completed NCT03678597 - Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin B ( ICSI-LB) N/A
Completed NCT03677492 - Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin D ( ICSI-CD) N/A
Completed NCT03678818 - Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin A (ICSI-LA) N/A
Completed NCT03678571 - Oocyte Vitrification Aided With Latrunculin A N/A
Completed NCT03678558 - Oocyte Vitrification Aided With Cytochalasin B N/A

External Links