Intrauterine AdhesionNCT07611474
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
A study testing Uterine stent group and Uterine ring + balloon + sodium hyaluronate gel in people with Intrauterine Adhesion and Intrauterine Adhesions, run by The Third Xiangya Hospital of Central South University at 1 site in China.
Trial summary
To evaluate the effect of uterine stents in preventing intrauterine adhesions after intrauterine operation and whether they meet the safety requirements for clinical use. The trial adopted a prospective, multicenter, randomized controlled, non-inferiority clinical trial design. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Intrauterine Adhesion, Intrauterine Adhesions
- What is being tested?
- Uterine stent group and Uterine ring + balloon + sodium hyaluronate gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
Dabao MD, 13017386201, forxudabao@126.com
About this study
To evaluate the effect of uterine stents in preventing intrauterine adhesions after intrauterine operation and whether they meet the safety requirements for clinical use. The trial adopted a prospective, multicenter, randomized controlled, non-inferiority clinical trial design. The target population of the trial was 200 women aged 20-40 years with intrauterine adhesions and surgical indications (referring to those with fertility requirements or menstrual blood drainage obstruction), who were randomly divided into an experimental group and a control group, with 100 cases in each group. The experimental group was the group with intrauterine stents placed in the uterine cavity after hysteroscopic intrauterine adhesion separation surgery, and the control group was the group with intrauterine rings + balloons + sodium hyaluronate gel placed in the uterine cavity. After 3 courses of artificial cycles, the patients were hospitalized for hysteroscopy review.
- Conditions
- Intrauterine Adhesion, Intrauterine Adhesions
- Being tested
- Uterine stent group, Uterine ring + balloon + sodium hyaluronate gel
- Medical subject headings
- Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterine stent groupDevice
After TCRA, uterine stents of different specifications were placed in the uterine cavity according to the different uterine cavity morphologies of the subjects, and the hysteroscope was inserted again to adjust the position of the uterine stent.
Uterine ring + balloon + sodium hyaluronate gelDevice
The subjects were hospitalized for TCRA surgery. After the surgery, different types of uterine rings were selected and inserted into the uterine cavity according to the morphology of the subjects' uterine cavity. At the same time, a No. 12 Foley catheter was left in the uterine cavity, and 2.5 ml of normal saline was injected into the catheter balloon. 2 ml of hyaluronic acid gel was injected into the uterine cavity on one side of the catheter. The doctor removed the Foley catheter on the first day after the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Uterine stent placement in the uterine cavity after hysteroscopic intrauterine adhesion separation surgery Receives: Device: Uterine stent group |
| Control group | Experimental | Uterine cavity insertion ring + balloon + sodium hyaluronate gel Receives: Device: Uterine ring + balloon + sodium hyaluronate gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrauterine adhesion rate
Refer to the 2017 American Fertility Association IUA guidelines AFS score. AFS score: The case with adhesion whose total AFS score decreased by ≥ 4 points was considered effective. The effective rate was calculated using the following formula: number of cases with total AFS score decreased by ≥ 4 points/total number of cases × 100%.
Measured: At 12 months after the index hysterectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start1 Jan 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine AdhesionStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hunan Haokang Medical Technology Co., Ltd., Beijing Tiantan Hospital, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Xu dabao, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611474
- Sponsor's protocol ID
- XY3-QX-ZGZ-1711A02
- Status last verified
- May 2025
- First submitted
- 11 Feb 2026
- Last updated
- 28 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07611474
- Acronym / sponsor ID
- XY3-QX-ZGZ-1711A02
- Conditions
- Intrauterine Adhesion, Intrauterine Adhesions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Hunan Haokang Medical Technology Co., Ltd., Beijing Tiantan Hospital, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effect of uterine stents in preventing intrauterine adhesions after intrauterine operation and whether they meet the safety requirements for clinical use. The trial adopted a prospective, multicenter, randomized controlled, non-inferiority clinical trial design. The target population of the trial was 200 women aged 20-40 years with intrauterine adhesions and surgical indications (referring to those with fertility requirements or menstrual blood drainage obstruction), who were randomly divided into an experimental group and a control group, with 100 cases in each group. The experimental group was the group with intrauterine stents placed in the uterine cavity after hysteroscopic intrauterine adhesion separation surgery, and the control group was the group with intrauterine rings + balloons + sodium hyaluronate gel placed in the uterine cavity. After 3 courses of artificial cycles, the patients were hospitalized for hysteroscopy review.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Uterine stent groupUterine stent placement in the uterine cavity after hysteroscopic intrauterine adhesion separation surgery |
| Control group | Experimental | Device: Uterine ring + balloon + sodium hyaluronate gelUterine cavity insertion ring + balloon + sodium hyaluronate gel |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uterine stent groupAfter TCRA, uterine stents of different specifications were placed in the uterine cavity according to the different uterine cavity morphologies of the subjects, and the hysteroscope was inserted again to adjust the position of the uterine stent. | Device | Experimental group |
| Uterine ring + balloon + sodium hyaluronate gelThe subjects were hospitalized for TCRA surgery. After the surgery, different types of uterine rings were selected and inserted into the uterine cavity according to the morphology of the subjects' uterine cavity. At the same time, a No. 12 Foley catheter was left in the uterine cavity, and 2.5 ml of normal saline was injected into the catheter balloon. 2 ml of hyaluronic acid gel was injected into the uterine cavity on one side of the catheter. The doctor removed the Foley catheter on the first day after the surgery. | Device | Control group |
Primary outcome
Intrauterine adhesion rate
Time frame: At 12 months after the index hysterectomy
Refer to the 2017 American Fertility Association IUA guidelines AFS score. AFS score: The case with adhesion whose total AFS score decreased by ≥ 4 points was considered effective. The effective rate was calculated using the following formula: number of cases with total AFS score decreased by ≥ 4 points/total number of cases × 100%.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uterine stent group and Uterine ring + balloon + sodium hyaluronate gel in people with Intrauterine Adhesion and Intrauterine Adhesions, run by The Third Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dabao MD (13017386201, forxudabao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrauterine adhesion rate (time frame: At 12 months after the index hysterectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.