Investigating the Association Between Diagnostic and Therapeutic Management Models and Prognosis of Intrauterine Adhesions Based on a Large-Scale Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Number of Participants with Pregnancy Outcome within 2 Years of Postoperative Pregnancy Preparation Following Intrauterine Adhesions Surgery
研究概览
简要总结
This research plan aims to explore a new diagnosis and treatment management model for intrauterine adhesions and verify its efficacy and feasibility through a multicenter real-world study. Intrauterine adhesions are a common gynecological disease that may affect women's fertility. The study will focus on several key issues:
- How do three-dimensional ultrasound image features reflect the diagnosis and prognosis of intrauterine adhesions;
- The effect of new diagnostic and treatment technologies (such as cold knife plowing technology and patented intrauterine stents) in preventing the recurrence of intrauterine adhesions
- The efficacy of traditional Chinese medicine prescriptions in promoting endometrial growth and preserving pregnancy;
- How to construct a postoperative infertility risk prediction model that combines multidimensional risk factors of traditional Chinese and Western medicine.
To achieve these goals, the study will:
- Establish four-dimensional ultrasound diagnostic evaluation standards to improve the accuracy of diagnosis;
- Build a large database and data cohort, standardize the diagnosis and treatment standards, and provide solid data support for the research;
- Evaluate the efficacy of the new model through real-world research, and compare the clinical efficacy of the new diagnosis and treatment model with the traditional diagnosis and treatment model;
- Construct and verify the postoperative infertility risk prediction model to provide clinicians with a visual display of risk prediction for clinical application.
This study is expected to provide a scientific basis for improving the treatment effect of intrauterine adhesions and reducing the infertility rate, and promote the standardization and standardization of the diagnosis and treatment model of combining traditional Chinese and Western medicine, bringing good news to more patients with intrauterine adhesions.
详细描述
Research purpose: This project intends to explore the efficacy of the new IUA diagnosis and treatment model through multi-center real-world research and prove that it is a high-quality medical service model, laying the foundation for its future promotion.
Experimental design: Based on previous research, our team proposed a "new model for the management and treatment of IUA throughout the entire course of disease": preoperative four-dimensional color ultrasound diagnosis and evaluation, intraoperative use of integrated hysteroscopy "immediate diagnosis and treatment" cold knife plowing adhesion separation, postoperative application of patented uterine cavity stent to prevent re-adhesion, postoperative use of famous doctors and famous prescriptions to promote endometrial repair, postoperative use of four-dimensional color ultrasound evaluation follow-up instead of multiple hysteroscopy, combined with intraoperative hysteroscopy endometrial gland opening AI counting gland density, multimodal data fusion prediction and evaluation of pregnancy prognosis after IUA treatment.
Experimental process: Prospective, observational real event study Inclusion criteria: Patients with intrauterine adhesions diagnosed and treated in our hospital and the sub-center units of this project: age 18-45 years old; collection began after the ethical review, a total of 5,000 cases were collected, and 2,000 cases were collected in this center.
Exclusion criteria: abnormal ovarian function, male infertility, and those who cannot cooperate with diagnosis, treatment and follow-up
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Patients with intrauterine adhesions diagnosed and treated in our hospital and the sub-central units of this project: aged 18-45 years old; The collection began after the ethical review was passed. A total of 5,000 cases were collected, and 2,000 cases were collected in this center.
排除标准
- •Abnormal ovarian function, male infertility, inability to cooperate with diagnosis and treatment and follow-up visits
研究组 & 干预措施
A new model of full-course management and diagnosis and treatment for IUA
干预措施: Transcervical resection of adhesion (Procedure)
A new model of full-course management and diagnosis and treatment for IUA
干预措施: Uterine cavity stent (Procedure)
A new model of full-course management and diagnosis and treatment for IUA
干预措施: Traditional Chinese medicine for tonifying the kidney (Drug)
结局指标
主要结局
Number of Participants with Pregnancy Outcome within 2 Years of Postoperative Pregnancy Preparation Following Intrauterine Adhesions Surgery
时间窗: From the start of postoperative pregnancy preparation up to 2 years
Based on the constructed IUA integrated traditional Chinese and Western medicine cohort data, data standardization processing was carried out to establish a multi-dimensional candidate variable dataset that may be related to infertility after IUA surgery. It includes multi-dimensional diagnosis and treatment data of both traditional Chinese and Western medicine, such as age, lifestyle and behavioral patterns, family history, laboratory tests, surgical conditions, male semen and sexual life conditions, combined variables of three-dimensional ultrasound image features and combined variables of TCM syndrome elements. Meanwhile, the follow-up results of the corresponding population were sorted out, that is, the pregnancy outcome within 2 years of postoperative pregnancy preparation.
次要结局
未报告次要终点