premature ovarian insufficiency
Conditions
Interventions
Stem cell therapy group:Intravenous injection of human amniotic epithelial stem cells and hormone replacement therapy for 3 cycles
control group:hormone replacement therapy for 3 cycles
Sponsors
Women's Hospital School Of Medicine Zhejang University
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1.Female, aged>=20 and 25IU/L twice (with an interval of more than 4 weeks); 3.Transvaginal ultrasound: The sum of AFC with bilateral ovarian diameters of 2-10mm is less than 5; 4.Willingness to have children; 5.Body Mass Index (BMI) range: 18.5 <= BMI < 24; 6. Having good follow-up conditions, able to understand and comply with the agreement; 7.Willing to participate in the study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1.Chromosomal karyotype abnormalities; 2.Suffering from genetic diseases and family history related to fertility; 3.Suffering from reproductive system diseases that may affect fertility outcomes, such as abnormal genital development, endometritis, polycystic ovary syndrome, endometriosis (stages III-IV), and adenomyosis; 4.During pregnancy or lactation; 5.History of gynecological malignant tumors in the past 3 years; 6. Having an active and uncontrollable infectious diseases requiring systemic treatment; 7. Human immunodeficiency virus (HIV) infection or syphilis positivity, and/or active hepatitis B or C virus infection; 8.There are contraindications, allergies, or hypersensitivity reactions to any investigational drug or its excipients; 9.Patients with severe autoimmune diseases or familial genetic diseases; 10. Patients with severe anemia, liver disease, kidney disease, and lung disease; 11.Suffering from mental illness within the past 6 months; 12.History of drug and/or alcohol abuse/dependence in the past 2 years; 13.The patient also participates in any other clinical studies that involve the use of intervention drugs or examination procedures. 14.Researchers believe that it is not suitable to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ovarian reserve function before and after treatment: including the changes of serum AMH and basic sex hormone levels and antral follicle count (AFC); | — |
Secondary
| Measure | Time frame |
|---|---|
| Menstrual cycle, quantity and characteristics before and after treatment;Ovarian blood flow, ovarian volume, number of dominant follicles (DFC) and ovulation before and after treatment;Natural pregnancy, live birth, abortion or assisted reproduction outcomes before and after treatment; | — |
Countries
China
Contacts
Public ContactZhang Dan
Women's Hospital School Of Medicine Zhejang University
Outcome results
None listed