A Prediction Model and Assisted Decision-making System of Fertilization Disorders: a Single-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Incidence of fertilization disorders
研究概览
简要总结
The goal of this clinical trial is to test the accuracy of the forecasting system we develop. The main question it aims to answer is:
- Whether the clinical prediction system predicts the incidence of fertilization disorders accurately.
- The fertilization disorder prediction system predicts whether and how much the outcome differs from the doctor.
Participants will receive treatment assisted by a predictive system or receive general treatment.
Researchers will compare incidence of fertilization disorders to see if the fertilization disorder prediction system makes correct predictions.
详细描述
Through the design method of single-center randomized controlled trial, 260 infertility patients were recruited, and they were divided into two groups of 130 cases in each group according to the method of block randomization, one of which was the intervention group, with the help of accurate prediction of fertilization disorders and clinical decision support systems, clinicians predicted and judged the probability and key factors of fertilization disorders of patients, and formulated and implemented personalized diagnosis and treatment plans based on the prediction results; The other group is the control group, which is treated by clinicians according to the conventional diagnosis and treatment plan, and the system performs parallel simulation operation to predict the outcome of fertilization disorders in patients without affecting any diagnosis and treatment decisions of clinicians. Through the comparison of the two groups, the predictive ability of the system for fertilization disorders was evaluated, and the effectiveness and safety of the personalized diagnosis and treatment plan formulated with the assistance of the system were observed, the primary observation outcomes were the incidence of fertilization disorders, and the secondary observation outcomes were embryo transfer rate, biochemical pregnancy rate, clinical pregnancy rate, etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •infertile couples
- •have indications for acceptance of IVF or ICSI
- •Both parties sign an informed consent form and can complete the follow-up visit
排除标准
- •At least one of the spouses has contraindics to IVF or ICSI
- •Major diseases
- •Fresh cycle, PGT, IVM
结局指标
主要结局
Incidence of fertilization disorders
时间窗: through study completion, an average of 3 months
Occurrence of fertilization disorders in participants
次要结局
未报告次要终点
