A combined 4D ultrasound, hysteroscopic cold-knife plowing, uterine stent, and traditional Chinese medicine approach for intrauterine adhesions
Investigating the Association Between Diagnostic and Therapeutic Management Models and Prognosis of Intrauterine Adhesions Based on a Large-Scale Prospective Cohort Study
This project will try a combined care pathway—preoperative 4D ultrasound, hysteroscopic cold-knife adhesion separation, a postoperative uterine stent, and traditional Chinese medicine—to see if it improves outcomes for women aged 18–45 with intrauterine adhesions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5000 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | The Third Xiangya Hospital of Central South University Academic / other |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT07421908 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter real-world cohort enrolling up to 5,000 cases (2,000 at the lead center) of women aged 18–45 treated for intrauterine adhesions. Patients receive preoperative four-dimensional color ultrasound, intraoperative integrated hysteroscopy with cold-knife plowing for immediate adhesion separation, placement of a patented uterine cavity stent to prevent re-adhesion, and postoperative traditional Chinese medicine prescriptions to promote endometrial repair. Follow-up uses 4D ultrasound combined with intraoperative AI gland-density counts and multimodal data fusion to build a postoperative infertility risk prediction model and track pregnancy outcomes. The study aims to test feasibility and real-world effectiveness of the full management model across participating centers.
Who should consider this trial
Good fit: Women aged 18–45 diagnosed with intrauterine adhesions at the participating centers who can comply with diagnosis, treatment, and follow-up are ideal candidates.
Not a fit: Patients with abnormal ovarian function, primary male-factor infertility, or who cannot adhere to treatment and follow-up schedules are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the combined pathway could reduce adhesion recurrence, improve endometrial recovery and pregnancy outcomes, and reduce the need for repeat hysteroscopies.
How similar studies have performed: Components such as hysteroscopic adhesiolysis and uterine stents have mixed evidence and traditional Chinese medicine has variable support, while the integrated model with cold-knife plowing, 4D ultrasound follow-up, and AI gland-density analysis is novel and not yet proven in large cohorts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Abnormal ovarian function, male infertility, inability to cooperate with diagnosis and treatment and follow-up visits
Where this trial is running
Changsha, Hunan
- The Third Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Dabao Xu
- Email: forxudabao@126.com
- Phone: +86 13017386201
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.