Real-World Effectiveness of Guishen Yijing Formula in the Treatment of Diminished Ovarian Reserve: A Single-Center Retrospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Change in Serum Anti-Müllerian Hormone (AMH) Level
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Serum Anti-Müllerian Hormone (AMH) Level
时间窗: From baseline to 3 months after treatment initiation
Change in serum AMH level before and after 3 months of treatment, measured by blood test.
次要结局
- Serum Follicle-Stimulating Hormone (FSH)(From baseline to 3 months after treatment initiation)
- Serum Luteinizing Hormone (LH)(From baseline to 3 months after treatment initiation)
- FSH/LH Ratio(From baseline to 3 months after treatment initiation)
- Serum Estradiol (E2)(From baseline to 3 months after treatment initiation)
- Safety and Adverse Events(From baseline to 3 months after treatment initiation)
- Traditional Chinese Medicine Syndrome Score(before and 1 month after the treatment)
- Modified Kupperman Menopausal Index (KMI)(before and 1 month after the treatment)
- Incidence of Treatment-Emergent Adverse Events(From baseline to 3 months after treatment initiation)
研究者
Shi Yun
Head of Gynecology
Dongzhimen Hospital, Beijing