diminished ovarian reserve
Conditions
Interventions
high dose group:Zishen Yutai Pills
low dose group:Zishen Yutai Pills
Placebo group:Placebo
Sponsors
Guang’anmen Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 39 Years
Inclusion criteria
Inclusion criteria: 1. Conform to the diagnosis of diminished ovarian reserve; 2. TCM syndrome differentiation is spleen and kidney deficiency syndrome; 3. Females aged < 40 years with a history of sexual life; 4. The patient voluntarily participates in this clinical trial, gives informed consent and signs a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Any menstrual cycle 49 days in the last 3 months; 2. Combined with other reproductive endocrine or metabolic-immune disorders that affect ovarian reserve function or affect the evaluation of drug effectiveness, such as polycystic ovary syndrome, hyperprolactinemia (serum prolactin > 2.28 nmol/L (50 ug/L)), hyperandrogenemia (testosterone > 2 times the upper limit of normal reference values), poorly controlled thyroid disease (TSH not within normal reference values), Addison's disease, systemic lupus erythematosus, Crohn's disease, vitamin D deficiency (25(OH)D upper limit of normal reference values), etc.; 3. Chromosomal abnormalities, enzyme defects (e.g., galactosemia, etc.), tumors, or reduced ovarian reserve function due to surgery (e.g., ovarian surgery, uterine artery ligation, oophorectomy, etc.), radiotherapy, chemotherapy, etc.; 4. Congenital abnormalities of the reproductive organs; 5. Untreated irregular vaginal bleeding of unknown origin, ovarian tumors, adnexal masses >= 4 cm, stage III-IV endometriosis or bilateral ovarian endometriotic cysts, fibroids >= 4 cm in diameter, endometrial polyps >1.5 cm. Pelvic surgery is expected to be performed during the trial; 6. Breast ultrasound BI-RADS grade >= 4 with known or suspected precancerous lesions (e.g., endometrial atypia/endometrial intraepithelial neoplasia) or malignant tumors (e.g., endometrial cancer, breast cancer) affected by sex hormones; 7. BMI >= 30 kg/m2; 8. Patients with HIV infection, pelvic tuberculosis or septic pelvic inflammatory disease; 9. Patients who have used oral contraceptives, GnRH agonists within 3 months prior to screening; 10. Patients who have received traditional Chinese medicine, western medicine or treatment for reduced ovarian reserve function such as natural estrogen, natural progesterone, Kuntai capsules, DHEA, growth hormone, melatonin, coenzyme Q10, vitamin D supplements, hormone-containing health products, etc.; 11. Combined with hypertension with poorly controlled blood pressure (poorly controlled means systolic blood pressure >= 160 mmHg and/or diastolic blood pressure >= 100 mmHg) despite standard drug therapy; 12. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 1.5 times the upper limit of the normal reference value, or blood creatinine (Scr) greater than the upper limit of the normal reference value 13. Combined with cardiovascular, cerebrovascular, hepatic, renal, haematopoietic or other serious systemic disease, and psychiatric or mental disorders; 14. Patient is allergic to the components of the test drug; 15. Patient has participated in another clinical trial within 3 months prior to randomisation; 16. Patients who have smoked more than 10 cigarettes per day within 3 months prior to screening; 17. Suspected or confirmed alcohol or drug abuse; 18. Pregnant or lactating women, subjects or their spouses who are planning to become pregnant or who do not wish to use only instrumental contraception (without a sex hormone component) from the screening period until 1 month after discontinuation of intervention 19. In the opinion of the investigator,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| anti-mullerian hormone; | — |
Secondary
| Measure | Time frame |
|---|---|
| Antral follicle count;FSH normalization rate;FSH/LH ratio;five sex hormones (FSH, LH, E2, PRL, T);ovarian volume;serum inhibin B;Normalization rate of menstrual cycle (rate of patients with menstrual cycle of 28-25 days);menstrual score;TCM syndrome score and curative effect;progesterone;endometrial status;adverse events;vital signs;physical examination;blood routine examination;routine urine and urine sediment microscopy;routine stool+occult blood examination;liver function;renal function;12-lead ECG examination;Breast ultrasound; | — |
Countries
China
Contacts
Public ContactRuihua Zhao
Guang’anmen Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed