Clinical trial Recruiting at 1 site Interventional Ages 20 to 40 Women only

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.

More Intrauterine Adhesion trials

Quick facts

Study typeInterventional
Ages20 Years to 40 Years
SexWomen only
Enrollment200 (estimated)
SponsorThe Third Xiangya Hospital of Central South University
Academic / other
Locations1 site (Changsha, Hunan)
StatusRecruiting
StartedJanuary 1, 2021
Main results expectedDecember 31, 2026
Study endsDecember 31, 2031
Registry record updatedMay 28, 2026
Trial IDNCT07611474 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.