Diminished Ovarian Reserve
Conditions
Interventions
Intervention group:The modified Huyang Yangkun Formula granules
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1) Age between 18 and 40 years. 2) Serum anti-Müllerian hormone (AMH) < 1.1 ng/mL, or antral follicle count (AFC) < 5–7 follicles in both ovaries. 3) Basal serum follicle-stimulating hormone (FSH) levels between 10 and 25 IU/L, measured in two consecutive menstrual cycles. 4) Menstrual cycle length = 60 days. 5) Diagnosis of the Traditional Chinese Medicine (TCM) pattern of Spleen and Kidney deficiency (Pi-Shen Bu Zu). 6) Voluntary provision of written informed consent, with agreement to comply with the follow-up schedule as required by the study protocol.
Exclusion criteria
Exclusion criteria: 1) Patients with menstrual disorders attributable to congenital gonadal dysplasia or acquired organic diseases; 2) Patients with menstrual disorders resulting from endocrine disorders, including but not limited to polycystic ovary syndrome (PCOS), hyperprolactinemia, dysfunctional uterine bleeding, hypogonadotropic hypogonadism, and hyperthyroidism; 3) Patients with known hypersensitivity or allergy to the investigational medicinal products; 4)Patients with a body mass index (BMI) = 30 kg/m²; 5) Patients who smoke = 10 cigarettes per day; 6) Patients with any of the following gynecological or oncological conditions: abnormal vaginal bleeding within the past 12 months, clinically relevant abnormalities confirmed by endometrial biopsy, or undiagnosed irregular vaginal bleeding; suspected cervical cancer or cervical precancerous lesions; suspected malignant breast neoplasms; or a known or suspected history of hormone-dependent tumors or other malignancies; 7) Patients with severe psychiatric disorders, or clinically significant suicidal ideation as assessed by the investigator; 8) Patients with uncontrolled or currently diagnosed comorbidities that may interfere with or affect the study treatment, such as severe hepatic, renal, cardiovascular, or cerebrovascular diseases; cholecystitis; cholelithiasis; uncontrolled or untreated hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg); or diabetes mellitus; 9) Patients who have participated in other interventional clinical trials within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decline rate of anti-Müllerian hormone(AMH); | — |
Secondary
| Measure | Time frame |
|---|---|
| Antral Follicle Count;Serum sex hormone levels;Menstrual cycle; | — |
Countries
China
Contacts
Public ContactHongyan YANG
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed