An Evaluation of the Relationship Between Physiological Parameters of Stress and In Vitro Fertilization Outcome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 18
- 主要终点
- Physiological Stress
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Medical history of cardiac arrhythmias
- •History of cardiac surgery within a year of study enrollment
结局指标
主要结局
Physiological Stress
时间窗: 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.
次要结局
未报告次要终点