Guishen Yijing Formula for Diminished Ovarian Reserve: A Real-World Retrospective Study (GSYJ;DOR)
Real-World Effectiveness of Guishen Yijing Formula in the Treatment of Diminished Ovarian Reserve: A Single-Center Retrospective Observational Study
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Beijing, Kina
- Dongzhimen Hospital, Beijing University of Chinese Medicine
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in Serum Anti-Müllerian Hormone (AMH) Level
Tidsram: From baseline to 3 months after treatment initiation
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Change in serum AMH level before and after 3 months of treatment, measured by blood test.
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From baseline to 3 months after treatment initiation
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Serum Follicle-Stimulating Hormone (FSH)
Tidsram: From baseline to 3 months after treatment initiation
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Blood samples are collected before and after treatment.
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From baseline to 3 months after treatment initiation
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Serum Luteinizing Hormone (LH)
Tidsram: From baseline to 3 months after treatment initiation
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Blood samples are collected before and after treatment.
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From baseline to 3 months after treatment initiation
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FSH/LH Ratio
Tidsram: From baseline to 3 months after treatment initiation
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Change in FSH/LH ratio before and after treatment.
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From baseline to 3 months after treatment initiation
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Serum Estradiol (E2)
Tidsram: From baseline to 3 months after treatment initiation
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Blood samples are collected before and after treatment.
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From baseline to 3 months after treatment initiation
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Traditional Chinese Medicine Syndrome Score
Tidsram: 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.
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before and 1 month after the treatment
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Modified Kupperman Menopausal Index (KMI)
Tidsram: before and 1 month after the treatment
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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.
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before and 1 month after the treatment
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Incidence of Treatment-Emergent Adverse Events
Tidsram: From baseline to 3 months after treatment initiation
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The incidence of treatment-emergent adverse events during the treatment period will be assessed, including gastrointestinal symptoms and abnormalities in liver and renal function.
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From baseline to 3 months after treatment initiation
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Pregnancy Rate
Tidsram: From baseline to 3 months after treatment initiation
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The proportion of participants with fertility needs who achieved pregnancy during the 3-month treatment period will be recorded as an exploratory outcome.
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From baseline to 3 months after treatment initiation
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 2025DZMEC-598-02
- DZMG-ZLZX-25006 (Annat bidrag/finansieringsnummer: Dongzhimen Hospital，Beijing University of Chinese Medicine)
- 90011461220907 (Annat bidrag/finansieringsnummer: Beijing University of Chinese Medicine)
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