跳至主要内容
临床试验/NCT05730764
NCT05730764招募中不适用

A Prediction Model and Assisted Decision-making System of Fertilization Disorders: a Single-center Randomized Controlled Trial

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2024年1月15日最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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