Intrauterine AdhesionNCT07421908
Investigating the Association Between Diagnostic and Therapeutic Management Models and Prognosis of Intrauterine Adhesions Based on a Large-Scale Prospective Cohort Study
A study testing Transcervical resection of adhesion, Uterine cavity stent and Traditional Chinese medicine for tonifying the kidney in people with Intrauterine Adhesion, run by The Third Xiangya Hospital of Central South University at 1 site in China.
Trial summary
This research plan aims to explore a new diagnosis and treatment management model for intrauterine adhesions and verify its efficacy and feasibility through a multicenter real-world study. Intrauterine adhesions are a common gynecological disease that may affect women's fertility. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrauterine Adhesion
- What is being tested?
- Transcervical resection of adhesion, Uterine cavity stent and Traditional Chinese medicine for tonifying the kidney
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 1 Mar 2035
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Abnormal ovarian function, male infertility, inability to cooperate with diagnosis and treatment and follow-up visits
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 Xu, +86 13017386201, forxudabao@126.com
About this study
This research plan aims to explore a new diagnosis and treatment management model for intrauterine adhesions and verify its efficacy and feasibility through a multicenter real-world study. Intrauterine adhesions are a common gynecological disease that may affect women's fertility. The study will focus on several key issues:
- How do three-dimensional ultrasound image features reflect the diagnosis and prognosis of intrauterine adhesions;
- The effect of new diagnostic and treatment technologies (such as cold knife plowing technology and patented intrauterine stents) in preventing the recurrence of intrauterine adhesions
- The efficacy of traditional Chinese medicine prescriptions in promoting endometrial growth and preserving pregnancy;
- How to construct a postoperative infertility risk prediction model that combines multidimensional risk factors of traditional Chinese and Western medicine.
Read more
To achieve these goals, the study will:
- Establish four-dimensional ultrasound diagnostic evaluation standards to improve the accuracy of diagnosis;
- Build a large database and data cohort, standardize the diagnosis and treatment standards, and provide solid data support for the research;
- Evaluate the efficacy of the new model through real-world research, and compare the clinical efficacy of the new diagnosis and treatment model with the traditional diagnosis and treatment model;
- Construct and verify the postoperative infertility risk prediction model to provide clinicians with a visual display of risk prediction for clinical application.
This study is expected to provide a scientific basis for improving the treatment effect of intrauterine adhesions and reducing the infertility rate, and promote the standardization and standardization of the diagnosis and treatment model of combining traditional Chinese and Western medicine, bringing good news to more patients with intrauterine adhesions.
Read the detailed description
Research purpose: This project intends to explore the efficacy of the new IUA diagnosis and treatment model through multi-center real-world research and prove that it is a high-quality medical service model, laying the foundation for its future promotion.
Experimental design: Based on previous research, our team proposed a "new model for the management and treatment of IUA throughout the entire course of disease": preoperative four-dimensional color ultrasound diagnosis and evaluation, intraoperative use of integrated hysteroscopy "immediate diagnosis and treatment" cold knife plowing adhesion separation, postoperative application of patented uterine cavity stent to prevent re-adhesion, postoperative use of famous doctors and famous prescriptions to promote endometrial repair, postoperative use of four-dimensional color ultrasound evaluation follow-up instead of multiple hysteroscopy, combined with intraoperative hysteroscopy endometrial gland opening AI counting gland density, multimodal data fusion prediction and evaluation of pregnancy prognosis after IUA treatment.
Experimental process: Prospective, observational real event study Inclusion criteria: Patients with intrauterine adhesions diagnosed and treated in our hospital and the sub-center units of this project: age 18-45 years old; collection began after the ethical review, a total of 5,000 cases were collected, and 2,000 cases were collected in this center.
Exclusion criteria: abnormal ovarian function, male infertility, and those who cannot cooperate with diagnosis, treatment and follow-up
- Conditions
- Intrauterine Adhesion
- Being tested
- Transcervical resection of adhesion, Uterine cavity stent, Traditional Chinese medicine for tonifying the kidney
- Keywords
- Hysteroscopy, ploughing technique, cold scissors, Gland density, multi-center study
- Medical subject headings
- Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcervical resection of adhesionProcedure or surgery
During the operation, an integrated hysteroscopic "immediate diagnosis and immediate treatment" cold knife plowing type adhesion separation surgery was adopted
Uterine cavity stentProcedure or surgery
Made of medical-grade silicone rubber, it is non-irritating to human tissues, has no toxic side effects, is non-carcinogenic, has good biocompatibility, corrosion resistance, will not swell, soften or deteriorate due to water absorption, is easy to process and manufacture, convenient to use, and has good thermal stability. The uterine stent is mainly composed of the reinforcing ribs of the uterine ring, the membrane, the tail-shaped structure and the placement device. The placement device is composed of the placement sleeve, the positioning block and the push rod. It is made of medical silicone rubber. The uterine ring reinforcing ribs are elastic, and their shape and size are adapted to the periphery of the uterine wall. The lower end of the reinforcing ribs of the uterine ring is equipped with three drainage channels, which is more conducive to the drainage of uterine cavity effusion and reduces the probability of intrauterine infection caused by poor uterine cavity drainage.
Traditional Chinese medicine for tonifying the kidneyDrug
Traditional Chinese medicines for tonifying the kidney can promote blood circulation in the internal reproductive organs, significantly increase blood supply to the uterus, improve the receptivity of the endometrium, enhance the affinity of estrogen receptors in target tissues, promote endometrial proliferation, and improve secretory function
| Study group | Role | What they receive |
|---|---|---|
| A new model of full-course management and diagnosis and treatment for IUA | Experimental | Not described Receives: Procedure: Transcervical resection of adhesion; Procedure: Uterine cavity stent; Drug: Traditional Chinese medicine for tonifying the kidney |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Pregnancy Outcome within 2 Years of Postoperative Pregnancy Preparation Following Intrauterine Adhesions Surgery
Based on the constructed IUA integrated traditional Chinese and Western medicine cohort data, data standardization processing was carried out to establish a multi-dimensional candidate variable dataset that may be related to infertility after IUA surgery. It includes multi-dimensional diagnosis and treatment data of both traditional Chinese and Western medicine, such as age, lifestyle and behavioral patterns, family history, laboratory tests, surgical conditions, male semen and sexual life conditions, combined variables of three-dimensional ultrasound image features and combined variables of TCM syndrome elements. Meanwhile, the follow-up results of the corresponding population were sorted out, that is, the pregnancy outcome within 2 years of postoperative pregnancy preparation.
Measured: From the start of postoperative pregnancy preparation up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start1 Mar 2025
- Primary completion1 Mar 2030 (estimated)
- Study completion1 Mar 2035 (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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Changsha Jiangwan Maternity Hospital, Maternity and Child Health Hospital of Changsha
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421908
- Sponsor's protocol ID
- xy3-IUA-Xu
- Status last verified
- Feb 2026
- First submitted
- 15 May 2025
- Last updated
- 19 Feb 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 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Association Between Diagnostic and Therapeutic Management Models and Prognosis of Intrauterine Adhesions Based on a Large-Scale Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07421908
- Acronym / sponsor ID
- xy3-IUA-Xu
- Conditions
- Intrauterine Adhesion
- Keywords
- Hysteroscopy, ploughing technique, cold scissors, Gland density, multi-center study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Changsha Jiangwan Maternity Hospital, Maternity and Child Health Hospital of Changsha
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Mar 2030 (estimated)
- Study completion
- 1 Mar 2035 (estimated)
- First posted
- 19 Feb 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.
This research plan aims to explore a new diagnosis and treatment management model for intrauterine adhesions and verify its efficacy and feasibility through a multicenter real-world study. Intrauterine adhesions are a common gynecological disease that may affect women's fertility. The study will focus on several key issues:
- How do three-dimensional ultrasound image features reflect the diagnosis and prognosis of intrauterine adhesions;
- The effect of new diagnostic and treatment technologies (such as cold knife plowing technology and patented intrauterine stents) in preventing the recurrence of intrauterine adhesions
- The efficacy of traditional Chinese medicine prescriptions in promoting endometrial growth and preserving pregnancy;
- How to construct a postoperative infertility risk prediction model that combines multidimensional risk factors of traditional Chinese and Western medicine.
To achieve these goals, the study will:
- Establish four-dimensional ultrasound diagnostic evaluation standards to improve the accuracy of diagnosis;
- Build a large database and data cohort, standardize the diagnosis and treatment standards, and provide solid data support for the research;
- Evaluate the efficacy of the new model through real-world research, and compare the clinical efficacy of the new diagnosis and treatment model with the traditional diagnosis and treatment model;
- Construct and verify the postoperative infertility risk prediction model to provide clinicians with a visual display of risk prediction for clinical application.
This study is expected to provide a scientific basis for improving the treatment effect of intrauterine adhesions and reducing the infertility rate, and promote the standardization and standardization of the diagnosis and treatment model of combining traditional Chinese and Western medicine, bringing good news to more patients with intrauterine adhesions.
Detailed description
Research purpose: This project intends to explore the efficacy of the new IUA diagnosis and treatment model through multi-center real-world research and prove that it is a high-quality medical service model, laying the foundation for its future promotion.
Experimental design: Based on previous research, our team proposed a "new model for the management and treatment of IUA throughout the entire course of disease": preoperative four-dimensional color ultrasound diagnosis and evaluation, intraoperative use of integrated hysteroscopy "immediate diagnosis and treatment" cold knife plowing adhesion separation, postoperative application of patented uterine cavity stent to prevent re-adhesion, postoperative use of famous doctors and famous prescriptions to promote endometrial repair, postoperative use of four-dimensional color ultrasound evaluation follow-up instead of multiple hysteroscopy, combined with intraoperative hysteroscopy endometrial gland opening AI counting gland density, multimodal data fusion prediction and evaluation of pregnancy prognosis after IUA treatment.
Experimental process: Prospective, observational real event study Inclusion criteria: Patients with intrauterine adhesions diagnosed and treated in our hospital and the sub-center units of this project: age 18-45 years old; collection began after the ethical review, a total of 5,000 cases were collected, and 2,000 cases were collected in this center.
Exclusion criteria: abnormal ovarian function, male infertility, and those who cannot cooperate with diagnosis, treatment and follow-up
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A new model of full-course management and diagnosis and treatment for IUA | Experimental | Procedure: Transcervical resection of adhesion, Procedure: Uterine cavity stent, Drug: Traditional Chinese medicine for tonifying the kidney |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Abnormal ovarian function, male infertility, inability to cooperate with diagnosis and treatment and follow-up visits
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 |
|---|---|---|
| Transcervical resection of adhesionDuring the operation, an integrated hysteroscopic "immediate diagnosis and immediate treatment" cold knife plowing type adhesion separation surgery was adopted | Procedure or surgery | A new model of full-course management and diagnosis and treatment for IUA |
| Uterine cavity stentMade of medical-grade silicone rubber, it is non-irritating to human tissues, has no toxic side effects, is non-carcinogenic, has good biocompatibility, corrosion resistance, will not swell, soften or deteriorate due to water absorption, is easy to process and manufacture, convenient to use, and has good thermal stability. The uterine stent is mainly composed of the reinforcing ribs of the uterine ring, the membrane, the tail-shaped structure and the placement device. The placement device is composed of the placement sleeve, the positioning block and the push rod. It is made of medical silicone rubber. The uterine ring reinforcing ribs are elastic, and their shape and size are adapted to the periphery of the uterine wall. The lower end of the reinforcing ribs of the uterine ring is equipped with three drainage channels, which is more conducive to the drainage of uterine cavity effusion and reduces the probability of intrauterine infection caused by poor uterine cavity drainage. | Procedure or surgery | A new model of full-course management and diagnosis and treatment for IUA |
| Traditional Chinese medicine for tonifying the kidneyTraditional Chinese medicines for tonifying the kidney can promote blood circulation in the internal reproductive organs, significantly increase blood supply to the uterus, improve the receptivity of the endometrium, enhance the affinity of estrogen receptors in target tissues, promote endometrial proliferation, and improve secretory function | Drug | A new model of full-course management and diagnosis and treatment for IUA |
Primary outcome
Number of Participants with Pregnancy Outcome within 2 Years of Postoperative Pregnancy Preparation Following Intrauterine Adhesions Surgery
Time frame: From the start of postoperative pregnancy preparation up to 2 years
Based on the constructed IUA integrated traditional Chinese and Western medicine cohort data, data standardization processing was carried out to establish a multi-dimensional candidate variable dataset that may be related to infertility after IUA surgery. It includes multi-dimensional diagnosis and treatment data of both traditional Chinese and Western medicine, such as age, lifestyle and behavioral patterns, family history, laboratory tests, surgical conditions, male semen and sexual life conditions, combined variables of three-dimensional ultrasound image features and combined variables of TCM syndrome elements. Meanwhile, the follow-up results of the corresponding population were sorted out, that is, the pregnancy outcome within 2 years of postoperative pregnancy preparation.
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 19 Feb 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 Transcervical resection of adhesion, Uterine cavity stent and Traditional Chinese medicine for tonifying the kidney in people with Intrauterine Adhesion, 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 1 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 19 Feb 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 Xu (+86 13017386201, forxudabao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Pregnancy Outcome within 2 Years of Postoperative Pregnancy Preparation Following Intrauterine Adhesions Surgery (time frame: From the start of postoperative pregnancy preparation up to 2 years). 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 19 Feb 2026.