Intrauterine Adhesion Prevention With a Uterine Stent After Surgery
Official title: To Evaluate the Safety and Effectiveness of Intrauterine Adhesion Preventer in the Prevention and Treatment of Intrauterine Adhesions, a Prospective, Multicenter, Randomized Controlled Clinical Trial
Run by The Third Xiangya Hospital of Central South University · NCT07611474 · Data updated 2026-11-12
This trial tests whether placing a uterine stent after adhesion surgery helps prevent repeat adhesions in women aged 20–40 with intrauterine adhesions.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years to 40 Years |
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | The Third Xiangya Hospital of Central South University Academic / other |
| Locations | 1 site (Changsha, Hunan) |
| Status | Recruiting |
| Started | January 1, 2021 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2031 |
| Registry record updated | May 28, 2026 |
| Trial ID | NCT07611474 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 20–40 with diagnosed intrauterine adhesions who require surgical treatment and seek fertility or drainage benefits.
✕Probably not a fit
Patients with markedly abnormal uterine cavities, unavailable clear uterine anatomy, uterine malformations, or recent uterine perforation may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter randomized trial compares a uterine stent to a standard regimen of intrauterine rings, balloons, and sodium hyaluronate gel after hysteroscopic adhesion separation. It aims to determine safety and effectiveness for preventing intrauterine adhesions, using a non-inferiority design with 200 participants. Participants undergo a 3-cycle artificial hormonal regimen followed by hysteroscopy review to assess outcomes. Eligible women have fertility or drainage concerns and meet specified health criteria, while certain uterine conditions and medical histories exclude enrollment. The study is led by The Third Xiangya Hospital with several collaborating centers.
Why it matters
Potential benefit: If successful, the uterine stent could reduce the risk of recurrent intrauterine adhesions and improve reproductive and menstrual outcomes.
How similar studies have gone: Previous approaches using physical spacers and adjunctive materials have shown promise in reducing adhesions in similar settings, but this specific comparison is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Patients clinically diagnosed with intrauterine adhesions and with surgical indications (referring to those with fertility requirements or obstructed menstrual blood drainage) ② Women aged 20-40 years old; ③ Subjects voluntarily participated in the trial and signed informed consent.
Exclusion Criteria:
* ① Patients with obviously abnormal uterine cavity shape after surgery; those who could not clearly separate the normal uterine cavity anatomical morphology (i.e. bilateral or unilateral fallopian tube openings were not visible); those with reproductive organ malformations and uterine cavities that were too large or too small; those with recent uterine perforation; those with cervical insufficiency.
* Those with a history of intrauterine adhesions and treatment;
* Those with endometrial tuberculosis or suspected endometrial tuberculosis;
* Those with adenomyosis or uterine fibroids\>4cm;
* Those with a history of malignant tumors or suspected malignant tumors;
* Those with acute and chronic intrauterine infection and genital infection;
* Those with unexplained vaginal bleeding or suspected uterine malignant lesions;
* Those with severe anemia and abnormal coagulation function; those with a history of thrombosis; ⑨ Those in the acute stage of various diseases or severe systemic diseases;
* Those with severe mental illness and physical weakness who cannot tolerate this operation;
⑪ Those with severe heart, liver, and kidney function diseases;
⑫ Those with contraindications to anesthesia or surgery;
⑬ Those who have participated in clinical trials in the past three months.
* Those who are considered unsuitable for inclusion by the researchers.
Where it's running
-
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China Recruiting
Study contacts
- Study coordinator: Dabao MD
- Email: forxudabao@126.com
- Phone: 13017386201
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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A combined 4D ultrasound, hysteroscopic cold-knife plowing, uterine stent, and traditional Chinese medicine approach for intrauterine adhesions
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.
-
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.
-
Using engineered stem cell exosomes to treat thin endometrial lining in women
This study tests if a new treatment using special stem cell particles can help women with a thin uterine lining get thicker linings compared to standard treatments.
-
Using Platelet-rich Plasma to Improve Female Fertility
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.
-
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.