A combined 4D ultrasound, hysteroscopic cold-knife plowing, uterine stent, and traditional Chinese medicine approach for intrauterine adhesions
Official title: Investigating the Association Between Diagnostic and Therapeutic Management Models and Prognosis of Intrauterine Adhesions Based on a Large-Scale Prospective Cohort Study
Run by The Third Xiangya Hospital of Central South University · NCT07421908 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 5000 (estimated) |
| Sponsor | The Third Xiangya Hospital of Central South University Academic / other |
| Locations | 1 site (Changsha, Hunan) |
| Status | Recruiting |
| Started | March 1, 2025 |
| Main results expected | March 1, 2030 |
| Study ends | March 1, 2035 |
| Registry record updated | February 19, 2026 |
| Trial ID | NCT07421908 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Intrauterine Adhesion Prevention With a Uterine Stent After Surgery
This trial tests whether placing a uterine stent after adhesion surgery helps prevent repeat adhesions in women aged 20–40 with intrauterine adhesions.
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Intrauterine Stent Placement After Septum Resection
This trial tests whether placing a small intrauterine balloon stent for 7-10 days after hysteroscopic septum removal helps prevent scar tissue formation in people with a uterine septum.
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This study is testing whether injections of platelet-rich plasma can help improve fertility in women dealing with issues like poor ovarian response and repeated implantation failure.
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Comparing heparin solution and barrier gel for preventing intrauterine adhesions after surgery
This study is testing whether a heparin solution or a barrier gel is better at preventing scar tissue in the uterus after surgery for women who have had operative hysteroscopy.
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Comparison of operative hysteroscopy vs vacuum aspiration for first-trimester termination with intrauterine adhesions
In people with early pregnancy and intrauterine adhesions, this study tests whether hysteroscopy with adhesiolysis plus vacuum aspiration is safer or more effective than vacuum aspiration alone for terminating the pregnancy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.