instrauterine adhesions
Conditions
Interventions
Test group:decellularized dermal matrix used in the uterine cavity
control group:Crosslinked sodium hyaluronate gel used in the uterine cavity
Sponsors
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1) Age range from 18 to 45 years old (including 18 and 45 years old), female; (2) Clinically diagnosed as moderate to severe intrauterine adhesions; (3) Those who have undergone hysteroscopic separation of intrauterine adhesions; (4) Agree to participate in this clinical trial and have signed the subject's informed consent form; (5) Pregnancy tests for women of childbearing age are negative.
Exclusion criteria
Exclusion criteria: (1) Patients with liver and kidney dysfunction (ALT, AST >= 1.5ULN, Cr >= 1.5ULN); (2) Individuals with autoimmune diseases, thrombotic diseases, and hematopoietic system disorders; (3) Individuals with cervical cancer, endometrial malignancy, or atypical endometrial hyperplasia; (4) Pregnant or lactating women; (5) Individuals without civil capacity; (6) Individuals who are allergic to collagen and/or pig derived materials; (7) Those who are not suitable to use pig derived medical products due to religious beliefs or other reasons; (8) Individuals who have participated in other clinical trials within the past three months; (9) The researchers believe that it is not suitable for participants in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate of treatment for intrauterine adhesions; | — |
Secondary
| Measure | Time frame |
|---|---|
| Menstrual evaluation;Uterine cavity morphology;Endometrial Thickness;Endometrial continuity;Product satisfaction; | — |
Countries
China
Contacts
Public ContactSongying Zhang
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Outcome results
None listed