Diminished Ovarian Reserve (DOR)
Conditions
Keywords
diminished ovarian reserve, traditional Chinese medicine, Real World Study
Brief summary
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.
Interventions
DRUGGuishen Yijing Formula(Chinese herbal decoction)
Sponsors
Shi Yun
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Female patients aged 18 to 45 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum Anti-Müllerian Hormone (AMH) Level | From baseline to 3 months after treatment initiation | Change in serum AMH level before and after 3 months of treatment, measured by blood test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Follicle-Stimulating Hormone (FSH) | From baseline to 3 months after treatment initiation | Blood samples are collected before and after treatment. |
| Serum Luteinizing Hormone (LH) | From baseline to 3 months after treatment initiation | Blood samples are collected before and after treatment. |
| FSH/LH Ratio | From baseline to 3 months after treatment initiation | Change in FSH/LH ratio before and after treatment. |
| Serum Estradiol (E2) | From baseline to 3 months after treatment initiation | Blood samples are collected before and after treatment. |
| Traditional Chinese Medicine Syndrome Score | before and 1 month after the treatment | 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. |
| Modified Kupperman Menopausal Index (KMI) | before and 1 month after the treatment | 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. |
| Incidence of Treatment-Emergent Adverse Events | From baseline to 3 months after treatment initiation | The incidence of treatment-emergent adverse events during the treatment period will be assessed, including gastrointestinal symptoms and abnormalities in liver and renal function. |
Countries
China
Outcome results
None listed