Moderate to severe intrauterine adhesions
Conditions
Interventions
Experimental group:COLTRIX? CartiRegen collagen cartilage repair scaffold
Control group:Crosslinked sodium hyaluronate gel for uterine cavity
Sponsors
Hospital of Obstetrics and Gynecology affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria 1) The subjects were aged 18-40 years old (including 18 and 40 years old), female; 2) Patients diagnosed with moderate to severe uterine adhesions by hysteroscopy (AFS score =5); 3) Have not participated in other clinical investigators within 3 months; 4) The subjects fully understood the benefits and risks of this study and were still willing to participate and sign informed consent.
Exclusion criteria
Exclusion criteria: Exclusion criteria 1) mild intrauterine adhesions; 2) only intrauterine oral adhesion; 3) Malignant tumor; 4) Irregular vaginal bleeding for unknown reasons; 5) There are contraindications to pregnancy; 6) Patients with contraindications to hysteroscopy; 7) People who have a special belief that they cannot receive the product (the product source is pig), allergies, such as pig protein allergy, a history of autoimmune disease or a family history; 8) Other researchers believe that the candidates are not suitable for admission, such as the efficacy can not be evaluated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AFS score ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of uterine readhesion (%);Endometrial thickness;menstruation;Efficacy evaluation;Pregnancy outcome; | — |
Countries
China
Contacts
Public Contactsui long
Hospital of Obstetrics and Gynecology affiliated to Fudan University
Outcome results
None listed