Cardiac Output Monitoring in Patients Undergoing In Vitro Fertilization by Noninvasive Cardiac Impendence: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Cardiac output measurement with the use of non-invasive NICAS hemodynamic monitor
研究概览
简要总结
In this study we aim to evaluate hemodynamic effects of IVF treatment, with the use of the non invasive NICaS bioimpendence monitor.
Our study's primary end point is to evaluate the hemodynamic profile with the use of NICaS whole body impedance cardiography that occur throughout the IVF cycle in patients undergoing controlled ovarian stimulation during IVF treatment.
Secondary endpoints include:
Women will be asked to grade their pain score and level of anxiety by the use of the visual analogue score elicited throughout the study observation points, in order to examine whether pain scores and anxiety levels correlate with the hemodynamic changes throughout an IVF treatment cycle.
详细描述
This is a prospective, observational, single center study which will be conducted at the Rabin Medical Center (Beilinson Campus), Petach Tikva, Israel, a tertiary university hospital. Fifty healthy woman (≤45 years old) undergoing IVF treatment will be enrolled following filling out an informed consent form.
Study procedure:
Women will be recruited in the IVF department upon consulting with the fertility specialist. Following signed informed consent, patients' blood pressure will be measured using a non-invasive upper arm blood pressure. Cardiovascular monitoring will be carried out using non-invasive NICAS cardiac impedance cardiography by the use of two electrodes stickers which are pasted on the wrists for 6 minutes.
Monitoring will be performed on:
- 1-3rd day of the menstrual cycle prior to treatment with gonadotropins
- On the day of ovulation triggering
- On the day of ovum pickup prior to their entrance to the operating theater.
- On the day of embryo transfer.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women above 18-45 undergoing their first, second or third cycle of IVF treatment in Beilinson Hospital following obtaining written informed consents forums with the ability to comply with the study requirements will be included in our study.
排除标准
- •Women under age 18
- •Women with polycystic ovarian syndrome
- •Women with cardiomyopathy
- •Women with history of chronic hypertension
- •Women with a congenital heart disease
- •Women who are not able to comply with study requirements and can't sign an informed consent forum.
结局指标
主要结局
Cardiac output measurement with the use of non-invasive NICAS hemodynamic monitor
时间窗: On the day of ovum pickup prior to their entrance to the operating theater.
次要结局
- Cardiac output measurement with the use of non-invasive NICAS hemodynamic monitor(1-3rd day of the menstrual cycle prior to treatment with gonadotropins)