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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Beijing, China
- Dongzhimen Hospital, Beijing University of Chinese Medicine
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in Serum Anti-Müllerian Hormone (AMH) Level
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Serum Follicle-Stimulating Hormone (FSH)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Pregnancy Rate
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 2025DZMEC-598-02
- DZMG-ZLZX-25006 (Ander subsidie-/financieringsnummer: Dongzhimen Hospital，Beijing University of Chinese Medicine)
- 90011461220907 (Ander subsidie-/financieringsnummer: Beijing University of Chinese Medicine)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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