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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Beijing, Chine
- Dongzhimen Hospital, Beijing University of Chinese Medicine
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Serum Anti-Müllerian Hormone (AMH) Level
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Serum Follicle-Stimulating Hormone (FSH)
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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
Délai: before and 1 month after the treatment
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Change in TCM syndrome total score, main symptom score, and secondary symptom score before and after treatment.
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before and 1 month after the treatment
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Modified Kupperman Menopausal Index (KMI)
Délai: before and 1 month after the treatment
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Change in total Modified Kupperman Index score before and after treatment, assessing menopausal-like symptoms.
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before and 1 month after the treatment
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Safety and Adverse Events
Délai: From baseline to 3 months after treatment initiation
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Adverse events occurring during treatment will be recorded, including gastrointestinal symptoms and any abnormalities in liver and renal function.
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From baseline to 3 months after treatment initiation
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pregnancy Rate
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 2025DZMEC-598-02
- DZMG-ZLZX-25006 (Autre subvention/numéro de financement: Dongzhimen Hospital，Beijing University of Chinese Medicine)
- 90011461220907 (Autre subvention/numéro de financement: Beijing University of Chinese Medicine)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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