Ignite Creation Date:
2024-05-06 @ 6:13 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05589571
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-02
First Post:
2022-10-18
Brief Title:
Evaluation of the Impact of Stress on IVF Outcome
Sponsor:
Inception Fertility LLC
Organization:
Inception Fertility LLC
Study Overview
Official Title:
An Evaluation of the Relationship Between Physiological Parameters of Stress and In Vitro Fertilization Outcome
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 participants IVF cycle treatment and outcome data will be collected and analyzed in conjunction with the physiological data collected with the OTO device
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 participants IVF cycle treatment and outcome data will be collected and analyzed in conjunction with the physiological data collected with the OTO device
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None