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A multicenter, randomized controlled clinical trial to evaluate the efficacy and safety of uterine cavity repair membrane in the prevention of re-adhesion after hysteroscopic intrauterine adhesion separation

A multicenter, randomized controlled clinical trial to evaluate the efficacy and safety of uterine cavity repair membrane in the prevention of re-adhesion after hysteroscopic intrauterine adhesion separation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068271
Enrollment
Unknown
Registered
2023-02-13
Start date
2023-02-14
Completion date
Unknown
Last updated
2025-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intrauterine adhesion

Interventions

Test group:Use of uterine cavity repair membrane after separation of uterine cavity adhesion
Control Group:Combined use of intrauterine device after separation of intrauterine adhesion

Sponsors

Gulou Hospital affiliated to Nanjing University Medical College
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Women aged 20 to 40 (including 20 and 40); 2. BMI < 30 kg/m2; 3. The patient was diagnosed with uterine cavity adhesion by hysteroscopy, and the uterine cavity adhesion score was in line with the American Fertility Society (AFS) grade II (score 5-8 points); 4. The patient voluntarily participated in the clinical trial and signed the Informed Consent.

Exclusion criteria

Exclusion criteria: 1. Patients with genital tract infection; 2. Patients with malignant tumors; Patients with complex hyperplasia of endometrium and atypical hyperplasia; 3. Patients with intramural myoma or adenomyosis of the uterus, whose uterus is larger than 60 days of pregnancy, and accompanied by excessive menstruation; Submucosal myoma of uterus; 4. Patients with abnormal coagulation function, or serious heart, liver, lung, kidney and other important organ diseases, serious systemic diseases, immune insufficiency, and poor control of diabetes and hypertension; 5. Patients with severe allergic symptoms, especially those with collagen allergy; 6. Patients who have participated or are participating in clinical trials of other drugs or devices in the past 3 months; 7. Other patients who were determined by the researcher to be unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Success rate of preventing adhesion recurrence ;

Secondary

MeasureTime frame
Postoperative American Fertility Society (AFS) score and changes;Postoperative menstrual blood volume and changes;

Countries

China

Contacts

Public ContactWang Huiyan

Gulou Hospital affiliated to Nanjing University Medical College

whylm@hotmail.com+86 25 8310 6666

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026