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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
-
Beijing, China
- Dongzhimen Hospital, Beijing University of Chinese Medicine
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Serum Anti-Müllerian Hormone (AMH) Level
Prazo: From baseline to 3 months after treatment initiation
|
Change in serum AMH level before and after 3 months of treatment, measured by blood test.
|
From baseline to 3 months after treatment initiation
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Serum Follicle-Stimulating Hormone (FSH)
Prazo: From baseline to 3 months after treatment initiation
|
Blood samples are collected before and after treatment.
|
From baseline to 3 months after treatment initiation
|
|
Serum Luteinizing Hormone (LH)
Prazo: From baseline to 3 months after treatment initiation
|
Blood samples are collected before and after treatment.
|
From baseline to 3 months after treatment initiation
|
|
FSH/LH Ratio
Prazo: From baseline to 3 months after treatment initiation
|
Change in FSH/LH ratio before and after treatment.
|
From baseline to 3 months after treatment initiation
|
|
Serum Estradiol (E2)
Prazo: From baseline to 3 months after treatment initiation
|
Blood samples are collected before and after treatment.
|
From baseline to 3 months after treatment initiation
|
|
Traditional Chinese Medicine Syndrome Score
Prazo: before and 1 month after the treatment
|
Change in TCM syndrome total score, main symptom score, and secondary symptom score before and after treatment.
|
before and 1 month after the treatment
|
|
Modified Kupperman Menopausal Index (KMI)
Prazo: before and 1 month after the treatment
|
Change in total Modified Kupperman Index score before and after treatment, assessing menopausal-like symptoms.
|
before and 1 month after the treatment
|
|
Safety and Adverse Events
Prazo: From baseline to 3 months after treatment initiation
|
Adverse events occurring during treatment will be recorded, including gastrointestinal symptoms and any abnormalities in liver and renal function.
|
From baseline to 3 months after treatment initiation
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pregnancy Rate
Prazo: From baseline to 3 months after treatment initiation
|
The proportion of participants with fertility needs who achieved pregnancy during the 3-month treatment period will be recorded as an exploratory outcome.
|
From baseline to 3 months after treatment initiation
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 2025DZMEC-598-02
- DZMG-ZLZX-25006 (Número de outro subsídio/financiamento: Dongzhimen Hospital，Beijing University of Chinese Medicine)
- 90011461220907 (Número de outro subsídio/financiamento: Beijing University of Chinese Medicine)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .