NCT07737847尚未招募不适用
A Study on Biological Subtyping of Reduced Ovarian Reserve With Kidney Essence Deficiency Syndrome Based on Follicular Fluid Metabolomics and Efficacy Prediction of ShouTai Pills
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Number of MII oocyte
研究概览
简要总结
Grounded in the 'disease-syndrome combination' paradigm, this study endeavors to address the pivotal scientific issues pertaining to the clinical precision of Traditional Chinese Medicine (TCM) in managing Diminished Ovarian Reserve (DOR) classified as the Kidney Essence Deficiency type, through the application of systems biology technologies, including metabolomics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria are as follows: ① meeting the above-mentioned integrated Chinese and Western medicine diagnostic criteria for DOR
- •② no use of estrogen-containing medications within the past 1 month
- •③ patients scheduled to undergo IVF-ET
- •④ provision of signed informed consent, voluntary participation, and good compliance.
排除标准
- •The exclusion criteria are as follows: ① patients with polycystic ovary syndrome (PCOS) or stage III/IV endometriosis
- •② uterine conditions including untreated submucous myomas, intramural myomas >4 cm in diameter, intrauterine adhesions, uterine septum, or other uterine anomalies
- •③ couples undergoing preimplantation genetic diagnosis (PGD) for genetic reasons
- •④ body mass index (BMI) ≥28 kg/m²
- •⑤ history of prior pelvic radiotherapy or cytotoxic chemotherapy
- •⑥ significant systemic diseases, such as uncontrolled hypertension, diabetes mellitus, thyroid dysfunction, hepatic or renal insufficiency, cardiac disorders, or autoimmune diseases
- •⑦ use of medications that may interfere with this study within the past 1 month, including but not limited to estrogens, hepatic enzyme modulators, and agents that may affect the endocrine system (hormonal drugs)
- •⑧ known allergy to any components of the study medication
- •and ⑨ participation in another drug trial within the past 3 months. -
结局指标
主要结局
Number of MII oocyte
时间窗: After 3 months of medication, ovulation induction was performed, followed by oocyte retrieval upon completion of the induction cycle. The number of mature oocytes was recorded on the day of retrieval.
On the day of oocyte retrieval, the number of mature oocytes was observed under a microscope. Mature oocytes are defined as oocytes containing the first polar body.
次要结局
- FSH(Basline， and after 3 months of treatment)
- AMH(Basline， and after 3 months of treatment)
- number of oocytes retrieved(After 3 months of medication, ovulation induction was performed, followed by oocyte retrieval upon completion of the induction cycle. The number of mature oocytes was recorded on the day of retrieval.)
- AFC(Basline， and after 3 months of treatment)
- blastocyst formation rate(After 3 months of medication, ovulation induction and oocyte retrieval for fertilization are performed, recorded as Day 0. Blastocysts form on days 5/6 post-fertilization; thus, the blastocyst formation rate is assessed on Day 6)
- proportion of good-quality embryos(After 3 months of medication, ovulation induction and oocyte retrieval for fertilization are performed, recorded as Day 0. Cleavage embryos form on day3 post-fertilization; thus, the rate is assessed on Day 3)
研究者
研究点 (1)
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