Ovarian Function Decline
Conditions
Interventions
Experimental group:Participants will receive treatment for two consecutive cycles, with dosing initiated during the follicular phase of each menstrual cycle (Cycle 1 [C1] and Cycle 2 [C2]) (recommende
Control group:Participants will undergo two consecutive treatment cycles. Medication will be administered at the beginning of the follicular phase of each menstrual cycle (C1, C2) (it is recommended t
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
Female
Age
35 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Willing to voluntarily comply with the visit schedule and requirements specified in the protocol and sign a written informed consent form; 2. Female aged 35–40 years (inclusive); 3. BMI between 18–28 kg/m^2 (inclusive); 4. Poor ovarian reserve function according to POSEIDON group 4, and meeting all of the following screening period criteria: (1) AMH < 1.2 ng/mL; (2) Total bilateral AFC < 5 (measured by transvaginal ultrasound on days 2–4 of menstruation); (3) Basal FSH level between 10 IU/L and 25 IU/L (inclusive) (measured on days 2–4 of menstruation); 5. At least one previous failed standard ovulation induction cycle.
Exclusion criteria
Exclusion criteria: 1. Pregnant, lactating, or postmenopausal females. 2. Uterine malformation. 3. Diseases affecting ovulation, including Cushing's syndrome, congenital adrenal hyperplasia, androgen-secreting tumors, or clinically significant hyperprolactinemia. 4. Clinically significant thyroid dysfunction (TSH outside normal range at screening); exception: stable-dose thyroid replacement or anti-thyroid therapy with normal TSH. 5. Significant hepatic or renal impairment (ALT or AST > 2 × ULN; Cr > 1.5 × ULN). 6. History of coagulation disorders or long-term anticoagulant use; or INR > 1.5 at screening. 7. PLT < 90 × 10?/L at screening. 8. Uncontrolled hypertension (SBP = 160 mmHg or DBP = 100 mmHg). 9. NYHA Class III–IV; or MI, severe/unstable angina within 6 months. 10. History of stroke within 6 months prior to screening. 11. Uncontrolled diabetes (FPG = 7.0 mmol/L or HbA1c = 6.5%). 12. Active infection requiring systemic treatment. 13. Use of NAD? or NAD? precursors (nicotinamide, NR, NMN, etc.) within 1 month prior to screening. 14. Known allergy to injectable Coenzyme I (NAD?) or its excipients. 15. Active autoimmune disease or continuous immunosuppressive therapy (e.g., SLE, RA). 16. History of malignancy within 5 years or prior radiotherapy/chemotherapy. 17. Psychiatric/neurological disorders requiring medication (depression, anxiety, schizophrenia, epilepsy) or use of antiepileptic/antidepressant drugs. 18. Any other condition that may compromise trial safety, as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antral follicle count;Anti-Müllerian Hormone; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of follicles;Number of eggs retrieved;Number of MII oocytes;Fertilization rate;Number of high-quality embryos;Embryo implantation rate;Biochemical pregnancy rate;Clinical pregnancy rate; | — |
Countries
China
Contacts
Public ContactJie Qiao
Peking University Third Hospital
Outcome results
None listed