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.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
-
Beijing、中国
- Dongzhimen Hospital, Beijing University of Chinese Medicine
-
-
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
取样方法
研究人群
描述
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
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Serum Anti-Müllerian Hormone (AMH) Level
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Serum Follicle-Stimulating Hormone (FSH)
大体时间：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)
大体时间：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
大体时间：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)
大体时间：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
大体时间：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.
|
before and 1 month after the treatment
|
|
Modified Kupperman Menopausal Index (KMI)
大体时间：before and 1 month after the treatment
|
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.
|
before and 1 month after the treatment
|
|
Incidence of Treatment-Emergent Adverse Events
大体时间：From baseline to 3 months after treatment initiation
|
The incidence of treatment-emergent adverse events during the treatment period will be assessed, including gastrointestinal symptoms and abnormalities in liver and renal function.
|
From baseline to 3 months after treatment initiation
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pregnancy Rate
大体时间：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
|
合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.