Study of New Diagnosis and Treatment Approach for Intrauterine Adhesions Using Ultrasound, Cold Knife Surgery, Uterine Stents, and Traditional Chinese Medicine To Improve Fertility Outcomes in Women Aged 18 to 45

What This Trial Is About

Researchers are studying a new model for diagnosing and managing intrauterine adhesions, a common condition that may impact womens fertility. This large-scale, multicenter real-world study aims to improve diagnosis accuracy, evaluate new treatment technologies, assess traditional Chinese medicine effects, and develop a risk prediction model for infertility after treatment. The goal is to enhance treatment outcomes and standardize care by combining traditional Chinese and Western medicine approaches. The study involves a full-course management model including preoperative four-dimensional color ultrasound for diagnosis, intraoperative hysteroscopic cold knife plowing to separate adhesions, postoperative placement of a patented silicone uterine cavity stent to prevent re-adhesion, and use of traditional Chinese medicine prescriptions to aid endometrial repair. Follow-up includes ultrasound evaluation and AI-assisted gland density assessment to predict pregnancy prognosis after surgery. Participants diagnosed with intrauterine adhesions will be observed prospectively with data collected to build a large database and evaluate the new models effectiveness compared to traditional care. The main outcome is the number of participants achieving pregnancy within two years after surgery. The study includes assessments like ultrasound imaging and clinical follow-up, with a total enrollment of 5,000 cases. The study duration extends through 2035, allowing long-term evaluation of treatment results and infertility risk prediction.

Investigating the Association Between Diagnostic and Therapeutic Management Models and Prognosis of Intrauterine Adhesions Based on a Large-Scale Prospective Cohort Study