Actively Recruiting
Investigating the Association Between Diagnostic and Therapeutic Management Models and Prognosis of Intrauterine Adhesions Based on a Large-Scale Prospective Cohort Study
Led by The Third Xiangya Hospital of Central South University · Updated on 2026-02-19
5000
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
T
The Third Xiangya Hospital of Central South University
Lead Sponsor
C
Changsha Jiangwan Maternity Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying a new model for diagnosing and managing intrauterine adhesions, a common condition that may impact women's 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 model's 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.
CONDITIONS
Brief Title
Investigating the Association Between Diagnostic and Therapeutic Management Models and Prognosis of Intrauterine Adhesions Based on a Large-Scale Prospective Cohort Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 45 years
- Diagnosed with intrauterine adhesions
- Treated at the hospital or its sub-center units participating in this study
- Able to cooperate with diagnosis, treatment, and follow-up visits
- Enrollment started after ethical review approval
You will not qualify if you...
- Abnormal ovarian function
- Male infertility
- Unable to cooperate with diagnosis, treatment, or follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of surgical treatment and postoperative care period
Participants receive surgery involving immediate diagnosis and treatment of intrauterine adhesions with a cold knife plowing technique, placement of a uterine cavity stent to prevent re-adhesion, and postoperative use of traditional Chinese medicine to promote endometrial repair.
1 surgical visit and multiple postoperative visits for follow-up and medication management
Duration - Up to 2 years
Participants undergo follow-up evaluations including ultrasound assessments to monitor recovery and pregnancy prognosis for up to 2 years after postoperative pregnancy preparation.
Periodic visits during the 2-year postoperative pregnancy preparation period
Trial Site Locations
Total: 1 location
1
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013
Actively Recruiting
Research Team
D
Dabao Xu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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