Actively Recruiting
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
Led by The Third Xiangya Hospital of Central South University · Updated on 2026-05-28
200
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
T
The Third Xiangya Hospital of Central South University
Lead Sponsor
H
Hunan Haokang Medical Technology Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of uterine stents in preventing intrauterine adhesions after intrauterine surgery and whether these stents meet safety standards for clinical use. This prospective, multicenter, randomized controlled trial involves 200 women aged 20 to 40 years who have intrauterine adhesions and require surgery due to fertility needs or menstrual blood drainage obstruction. The study compares two groups to assess the prevention and treatment of these adhesions. One group receives uterine stents placed inside the uterine cavity following hysteroscopic adhesion separation surgery. The other group receives a combination of intrauterine rings, balloons, and sodium hyaluronate gel after the same surgery. The stents are adjusted with a hysteroscope, while the second group uses a Foley catheter balloon and hyaluronic acid gel, with the catheter removed one day post-surgery. After three cycles of artificial menstruation, patients are hospitalized for a hysteroscopy review. Participants will undergo evaluations including hysteroscopy at 12 months after surgery to measure the rate of intrauterine adhesions. The study involves monitoring the participants through these procedures to assess safety and effectiveness. The total follow-up period includes the initial surgery, three artificial menstrual cycles, and the final hysteroscopy examination to determine treatment outcomes.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 20 to 40 years
- Clinically diagnosed with intrauterine adhesions requiring surgery for fertility or menstrual blood drainage obstruction
- Voluntarily agree to participate and provide informed consent
You will not qualify if you...
- Patients with severely abnormal uterine shape after surgery or unclear uterine cavity anatomy
- Those with reproductive organ malformations or uterine cavities that are too large or too small
- Recent uterine perforation or cervical insufficiency
- History of intrauterine adhesions treatment
- Endometrial tuberculosis or suspected tuberculosis
- Adenomyosis or uterine fibroids larger than 4 cm
- History or suspicion of malignant tumors
- Acute or chronic intrauterine or genital infections
- Unexplained vaginal bleeding or suspected uterine malignancy
- Severe anemia, abnormal coagulation, or history of thrombosis
- Severe systemic diseases or acute disease stages
- Severe mental illness or physical weakness preventing surgery
- Severe heart, liver, or kidney diseases
- Contraindications to anesthesia or surgery
- Participation in other clinical trials within the past three months
- Considered unsuitable for inclusion by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and immediate post-operative period
Participants undergo hysteroscopic intrauterine adhesion separation surgery (TCRA) followed by placement of a uterine stent or insertion of a uterine ring with balloon and sodium hyaluronate gel in the uterine cavity.
1 surgery visit and 1 post-operative visit for catheter removal
Duration - Up to 12 months after surgery
Participants are monitored for the prevention and treatment of intrauterine adhesions after the intervention.
Follow-up visits as scheduled for up to 12 months
Trial Site Locations
Total: 1 location
1
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013
Actively Recruiting
Research Team
D
Dabao MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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