Decreased ovarian reserve
Conditions
Interventions
YPEG-rhG-CSF 0.5mg/2w group:YPEG-rhG-CSF was injected subcutaneously 0.5mg once every 2 weeks for 6 weeks
YPEG-rhG-CSF 1mg/2w group:YPEG-rhG-CSF was injected subcutaneously 1mg once every 2 weeks for 6 weeks
Control group:None
Sponsors
Chongqing Health Center for Women and Children
Eligibility
Sex/Gender
Female
Age
35 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Women aged between 35 and 45 years (including 35 and 45 years); 2. Body mass index (BMI) between 18 and 30 at screening; 3. Patients meeting the Poseidon criteria in Group 4 (patients >=35 years of age with low ovarian reserve (AFC < 5, AMH < 1.2ng /ml) and planning to use an antagonist regimen for IVF; 4. Patients undergoing IVF-ET treatment for the first time; 5. Patients voluntarily participate and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Known presence of benign/malignant tumors of the reproductive system, endometriosis, adenomyopathy, endometrial polyps, uterine adhesions, uterine malformations, or pelvic inflammatory diseases; 2. The patient stopped menstruating or had sporadic menstruation for 4 months, with FSH>25 U/L twice in a row at an interval of >4 weeks; 3. Contraindications of in vitro fertilization and embryo transfer (IVF-ET); 4. Patients who are allergic to polyethylene glycol recombinant human granulocyte colony-stimulating factor or any excipient of this product, or who meet contraindications for polyethylene glycol recombinant human granulocyte colony-stimulating factor; 5. Treatment with human granulocyte stimulating agents within 3 months prior to screening; plans or is using drugs that have potential drug interactions with human granulocyte stimulating agents, such as lithium; 6. Patients who are or plan to be pretreated with growth hormone (GH), dehydroepiandrosterone (DHEA), or Coenzyme Q10; 7. Previous malignant tumors; Or combined with serious lung, liver, kidney, heart, brain, blood vessel, endocrine system diseases, such as diabetes, refractory hypertension, hyperprolactinemia, thyroid dysfunction and other medical and surgical diseases; 8. The partner has severe oligospermia, weakness, teratospermia, or anspermia; 9. Combined with viral infection, such as hepatitis A, hepatitis C, hepatitis B, syphilis, AIDS, etc.; 10. Previous history of poorly controlled medication and mental illness; 11. Participants who have participated in a clinical trial of a drug within 3 months prior to screening or within 5 times the half-life specified in the other investigational drug label/Investigator manual/informed consent form, whichever is older, or under other circumstances deemed inappropriate by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expression of apoptosis-related genes (Bax, Bcl2, Caspase3) in granular cells of patients with DOR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ovarian reserve function;Gonadotropin (Gn) use;Embryo culture(number of eggs obtained, MII egg rate, normal fertilization rate, cleavage rate, quality embryo rate, available embryo rate, blastocyst formation rate); | — |
Countries
China
Contacts
Public ContactHong Ye
Chongqing Health Center for Women and Children
Outcome results
None listed