Intrauterien adhesion
Conditions
Interventions
experiment group A:Hysteroscopy + An invocational biomaterial containing mesenchymal stem cells derived exosome
Control group B:Hysteroscopy + Sodium hyaluronate
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
Female
Age
25 Years to 39 Years
Inclusion criteria
Inclusion criteria: 1. Aged 25-39 years; 2. Gender: female; 3. Diagnosis: intrauterine adhesion based on hysteroscopy. Score > 9 according to AFS (American Fertility Society); 4. Inform subjects that the purpose, methods and potential risks. Subjects agree to participate in the clinical study, and sign the consent form; 5. Follow the experimental plan and procedure.
Exclusion criteria
Exclusion criteria: 1. Primary infertility caused by chromosomal abnormalities and/or uterine anatomical abnormalities; 2. No desire or intolerance to pregnancy and/or childbirth; 3. Contraindications of hysteroscopy; 4. Contraindications of pregnancy; 5. Severe endometriosis and/or adenomyosis; 6. Treatment of contraindications with estrogen progesterone; 7. Malignant tumor; 8. Previously pelvic radiotherapy and/or abdominal chemotherapy; 9. Active infection and thrombosis; 10. Patients who had previously received pelvic radiotherapy and intra-abdominal local chemotherapy due to various factors; 11. Type I or II diabetes without control; 12. Severe cardiovascular disease, such as myocardial infarction, cardiac insufficiency, and grade III conduction block; 13. Asthma, chronic obstructive pulmonary disease, acute severe pneumonia, interstitial lung disease; 14. Acute or chronic renal failure, acute glomerulonephritis, acute urinary tract infection; 15. Severe liver diseases, such as severe hepatitis, cirrhosis, liver failure; 16. Hematological diseases, such as leukemia, lymphoma, anemia of unknown origin, coagulation abnormalities; 17. Severe neurological diseases, such as stroke, cerebrovascular malformation, and myasthenia gravis; 18. Metabolic disorder; 19. AIDS, syphilis, active hepatitis; 20. Any other disease of contraindications of treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| normal menstrual period 3-7/21-35, menstrual volume > 5mL;endometrial thickening (proliferative stage) >=3mm compared with pre-treatmemt; | — |
Countries
China
Contacts
Public ContactShaowei Wang
Beijing Hospital
Outcome results
None listed