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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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-
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Beijing, Kina
- Dongzhimen Hospital, Beijing University of Chinese Medicine
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Serum Anti-Müllerian Hormone (AMH) Level
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Serum Follicle-Stimulating Hormone (FSH)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Pregnancy Rate
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2025DZMEC-598-02
- DZMG-ZLZX-25006 (Annet stipend/finansieringsnummer: Dongzhimen Hospital，Beijing University of Chinese Medicine)
- 90011461220907 (Annet stipend/finansieringsnummer: Beijing University of Chinese Medicine)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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