Diminished Ovarian Reserve
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Female patients aged 18-40 years (inclusive) with fertility needs; (2) Unprotected sexual intercourse for at least 12 months without pregnancy and a clear diagnosis of infertility; (3) Patients diagnosed with ovarian reserve dysfunction (DOR) and ovulatory dysfunction according to Western medicine criteria (based on the 2022 "Expert Consensus on the Clinical Diagnosis and Treatment of Ovarian Reserve Dysfunction": AMH < 1.1 ng/mL; antral follicle count (AFC) < 5-7 on both ovaries; and a basal FSH level = 10 IU/L during two consecutive menstrual cycles); (4) Voluntary signing of informed consent.
Exclusion criteria
Exclusion criteria: (1) Severe organic diseases such as endometriosis adenomyosis or uterine fibroids; (2) Severe liver or kidney dysfunction a history of malignant tumors or major systemic diseases following radiotherapy or chemotherapy; (3) Age below 18 or above 40 years; (4) Infertility caused by other factors such as tubal factors autoimmune factors anatomical factors of the reproductive organs or male factors; (5) Patients currently participating in other clinical trials; (6) Patients with allergies (defined as allergy to two or more drugs or foods or known allergies to any components of the investigational drug used in this trial); (7) Patients receiving long-term exogenous hormone therapy; (8) Patients who do not meet the inclusion criteria have not followed the prescribed medication regimen cannot assess efficacy or have incomplete data that may affect the safety assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pregnancy rate;ovulation rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| AMH;Antral follicle count (AFC);Traditional Chinese Medicine Syndrome Score;sex hormone levels; | — |
Countries
China
Contacts
The First Affiliated Hospital of Hunan University of Chinese Medicine