Intrauterine Adhesions
Conditions
Interventions
Trial Group:Hysteroscopic adhesiolysis was performed, followed by immediate postoperative intrauterine infusion of 1 mL hyaluronic acid + 1 mL MSC-exos (containing 8×10? particles). A repeat intrauter
Control Group:Hysteroscopic adhesiolysis was performed, followed by immediate postoperative intrauterine infusion of 2 mL hyaluronic acid. A repeat intrauterine infusion of 2 mL hyaluronic acid was ad
Sponsors
The Second Hospital of Hebei Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-40 years; 2. Subjects diagnosed with moderate to severe intrauterine adhesions (IUA) based on American Fertility Society (AFS) or European Society for Gynaecological Endoscopy (ESGE) classification systems; 3. Body mass index (BMI) within 18-27 kg/m²; 4. Patients who have provided voluntary written informed consent after full disclosure of study details.
Exclusion criteria
Exclusion criteria: 1. History of confirmed or suspected hypersensitivity, severe adverse reactions, or atopic constitution to investigational agents; 2. Presence of active reproductive tract inflammation (e.g., endometritis, myometritis, vaginitis, acute/subacute cervicitis, acute/chronic pelvic inflammatory disease, genital tuberculosis, sexually transmitted infections) as determined by biochemical/immunological assessments; 3. Congenital or acquired uterine anatomical malformations; 4. Acute phase of systemic infectious disease; 5. Presence of genetic factors contributing to infertility; 6. Participation in any other clinical trial within one month prior to enrollment or concurrent participation; 7. Patients deemed medically unsuitable for enrollment per investigator's clinical judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-treatment Improvement in Intrauterine Adhesion Severity (Grade Change);Time to menstrual resumption and menstrual volume assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence rate of intrauterine adhesion recurrence;Rate of normalized endometrial thickness recovery (defined as endometrial thickness =6 mm); Pregnancy outcomes ; | — |
Countries
China
Contacts
Public ContactXianghua Huang
The Second Hospital of Hebei Medical University
Outcome results
None listed