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| ID | Type | Description | Link |
|---|---|---|---|
| DZMG-ZLZX-25006 | Other Grant/Funding Number | Dongzhimen Hospital，Beijing University of Chinese Medicine | |
| 90011461220907 | Other Grant/Funding Number | Beijing University of Chinese Medicine |
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The goal of this observational study is to learn about the real-world effectiveness of Guishen Yijing Formula in women with diminished ovarian reserve (DOR). The main question it aims to answer is:
Does Guishen Yijing Formula improve ovarian reserve function in women with DOR after 3 months of treatment? Medical records of participants who received Guishen Yijing Formula as part of their routine clinical care for DOR will be reviewed. Changes in anti-Müllerian hormone (AMH), follicle-stimulating hormone (FSH), and symptom scores before and after treatment will be analyzed.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guishen Yijing Formula(Chinese herbal decoction) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Anti-Müllerian Hormone (AMH) Level | Change in serum AMH level before and after 3 months of treatment, measured by blood test. | From baseline to 3 months after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Follicle-Stimulating Hormone (FSH) | Blood samples are collected before and after treatment. | From baseline to 3 months after treatment initiation |
| Serum Luteinizing Hormone (LH) | Blood samples are collected before and after treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy Rate | The proportion of participants with fertility needs who achieved pregnancy during the 3-month treatment period will be recorded as an exploratory outcome. | From baseline to 3 months after treatment initiation |
Inclusion Criteria:
Female patients aged 18 to 44 years Diagnosed with diminished ovarian reserve (DOR) with TCM syndrome differentiation of Kidney Deficiency and Liver Stagnation, and serum AMH < 1.1 ng/mL Received Guishen Yijing Formula with individualized modifications for 3 consecutive menstrual cycles
Exclusion Criteria:
Combined with serious systemic diseases, including cardiovascular, cerebrovascular, hematopoietic system disorders, or malignant tumors Primary amenorrhea, or family history of early menopause Diminished ovarian reserve caused by ovarian surgery or related surgical procedures Use of hormonal therapy or other treatments affecting ovarian function during the study period Pregnancy at baseline Incomplete medical records Loss to follow-up or significant missing data
biological
Female patients diagnosed with diminished ovarian reserve (DOR) who received Guishen Yijing Formula at the outpatient clinic of Dongzhimen Hospital, Beijing University of Chinese Medicine. Medical records were retrospectively reviewed from April 2016 to May 2025.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongzhimen Hospital, Beijing University of Chinese Medicine | Beijing | China |
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| From baseline to 3 months after treatment initiation |
| FSH/LH Ratio | Change in FSH/LH ratio before and after treatment. | From baseline to 3 months after treatment initiation |
| Serum Estradiol (E2) | Blood samples are collected before and after treatment. | From baseline to 3 months after treatment initiation |
| Traditional Chinese Medicine Syndrome Score | This syndrome score evaluates three primary symptoms and ten secondary symptoms related to traditional Chinese medicine syndrome differentiation. Total scores range from 0 to 48, with higher scores indicating more severe syndrome manifestations and a worse clinical outcome. | before and 1 month after the treatment |
| Modified Kupperman Menopausal Index (KMI) | The modified KMI consists of 13 menopausal symptoms, each rated on a 0-3 severity scale and weighted by symptom-specific coefficients. Total scores range from 0 to 63, with higher scores indicating more severe menopausal symptoms and a worse clinical outcome. | before and 1 month after the treatment |
| Incidence of Treatment-Emergent Adverse Events | The incidence of treatment-emergent adverse events during the treatment period will be assessed, including gastrointestinal symptoms and abnormalities in liver and renal function. | From baseline to 3 months after treatment initiation |