Premature ovarian insufficiency
Conditions
Interventions
Control group:Received saline solution + 0.3mg/ml hyaluronic acid injection therapy + standard treatment
Test group:Recipient undergoing umbilical cord mesenchymal stem cell transplantation combined with hyaluronic acid therapy + standard treatment
Sponsors
The Second Hospital of Shandong University
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1.Age 20 =4 months; (2). At least 2 serum basal FSH > 25 U/L (interval>4 weeks); 3.Sporadic POI; 4.Vaginal ultrasound showing ovary size >1 x 1 cm with antral follicles visible; 5.Secondary amenorrhoea, duration of amenorrhoea < 3 years; 6.No significant abnormalities in liver and kidney function: ALT and AST <=1.5 times of the upper limit of normal reference value, SCR and BUN <= the upper limit of normal reference value, normal heart function, no serious primary diseases in endocrine, nervous, and hematopoietic systems; 7.Subjects with good compliance, able to understand and cooperate to complete the ovarian function test, willing to voluntarily participate in the trial and follow-up according to the requirements of the protocol, and understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Known or suspected hypersensitivity to any of the components of the test cells or drugs and its excipients such as sodium hyaluronate; 2.Patients who have previously received stem cell therapy and are intolerant to stem cell therapy; 3.Ovarian resistant syndrome, abnormal reproductive tract development, polycystic ovary syndrome, hyperprolactinemia, ovarian endometrioations causing related symptomssis, uterine adhesions or thin endometrium, central nervous system tumors, functional hypothalamic amenorrhea, adrenal cortical dysfunction, chromosomal abnormalities, etc.; 4.Uncontrolled gynecological acute and chronic inflammation (including endometritis); 5.Taking other drugs (except artificial cycle drugs) or non-drug treatment (such as acupuncture, external application, enema, etc.) within the last 1 month, which makes the efficacy of stem cells difficult to judge; 6.Combined with mammary gland with BI-RADS grade > 3; 7.Patients with contraindications of femoston; 8.Patients with malignant tumor or previous history; 9.Patients with other serious diseases unsuitable for pregnancy or surgical treatment, such as severe heart disease, diabetes, hypertension, bleeding diseases, etc.; 10.Individuals with positive results of virological tests (HBV, HCV, HIV, TP, CMV, Epstein-Barr virus); 11.Individuals with intellectual disabilities, mental illness, or neurosis; 12.Suspected or confirmed history of alcohol and drug abuse; 13.Participated in other clinical trials in the past 3 months; 14.Combined with male infertility factors; 15.Other circumstances that the investigator deems inappropriate for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects with > 10mm follicles; | — |
Secondary
| Measure | Time frame |
|---|---|
| Follicle-Stimulating Hormone, FSH;Luteinizing Hormone, LH;anti-Müllerian hormone, AMH;Estradiol, E2;Percentage of subjects with increased Antral Follicle Counting;Spontaneous pregnancy rate;Number of oocytes retrieved during IVF;Double pronuclear embryo rate(2PN rate);High-quality embryo rate;Clinical pregnancy rate;Abortion rate;Live birth rate;Cytokines;T lymphocyte subsets;Serum immunoglobulin G;Incidence and severity of adverse events; | — |
Countries
China
Contacts
Public ContactCui Linlin
The Second Hospital of Shandong University
Outcome results
None listed