A Prospective Observational Study of Biomarkers for a Personalised IVF Treatment,
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- number of mature competent oocytes
研究概览
简要总结
Study investigates the effect of four-dimensional patient data (medical, lifestyle, environmental, and genetic) on the outcomes of ovarian stimulation for IVF.
Study will allow us to create a meaningful combination of medical knowledge, unique physician experience and information derived from data analysis. Additionally, the Study allows us to fine-tune the existing algorithms and develop new decision-supporting algorithms.
详细描述
Details of the ovarian stimulation and its outcomes for each patient will be analysed with the corresponding patient data collected or generated during the Study in the five streams as described under the headings "Stream one" to "Stream five".
Stream one: Personal and medical data Patient mobile app - collects up to 227 different data points about the female and additional up to 64 data points about her partner, Appendix 13.
Physician portal - mirrors the patient data from the mobile app and will provide tools for physician decision-making support and for error minimisation during the treatment using algorithms.
Stream two: Biorhythms and lifestyle Devices monitoring activity and health data (smart watches, bracelets, rings)
- Heart rate
- Respiratory rate
- Heart rate variability
- Blood oxygen level
- Sleeping cycle
- Sleeping respiratory rate
- Body temperature
- Activity - steps
- Stress level
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 否
入选标准
- •women aged 18-45 accompanied by a male partner;
- •diagnosis of infertility: one year of unprotected intercourse for patients under the age of 35; 6 months for patients aged 35 and older;
- •embryo transfer planned using fresh, autologous oocytes;
- •using the Oura Ring smart device and sharing health and lifestyle data through the device at least during the IVF treatment (from the beginning of ovarian stimulation until the pregnancy test).
排除标准
- •history of cancer or use of chemotherapeutic agents;
- •history of autoimmune disease (apart from thyroid disease);
- •known genetic conditions or balanced translocations causing disease or risk of disease which may require pre-implantation genetic testing;
- •use of donated oocytes;
- •stimulation protocols without polycystic ovary syndrome analogues.
结局指标
主要结局
number of mature competent oocytes
时间窗: 24 months
quality of oocytes which ensures high fertilisation rate
次要结局
未报告次要终点