NCT06102629尚未招募不适用
Understanding the Epigenetic Mechanisms in the Pathophysiology of Polycystic Ovary Syndrome for Efficient Diagnosis and Targeted Therapy
Asian Institute of Gastroenterology, India2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年11月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Evaluate the Analysis of DNA methyl transferases
研究概览
简要总结
OBJECTIVES:
- Analysis of DNA methyl transferases (DNMT1, DNMT3A and DNMT3B) and Histone deacetylases (HDAC 1,2,3 and SIRTs) polymorphisms (Somatic and germ line variations).
- Analysis of differential mRNA and protein expression of epigenetic markers in ovarian tissues obtained from PCOS patients.
- miRNA regulated epigenetic mechanisms in PCOS
- Epigenetic regulation of endocrine genes in PCOS
DESIGN : A Case Control study.Sample size:200
详细描述
- We will take both blood and ovarian tissue samples used to diagnosis.
- We will take approximately 3 ml of blood which will be used from the blood sample collected for routine preoperative tests (surgical profile) before their planned surgery or for disease evaluation.
- Small tissue samples (from ovary) will be taken from the tissue which is surgically excised as a part of treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All the subjects would be of Indian origin (controls ~100, cases ~100). They would be in their reproductive age (18-45 yrs). Rotterdam consensus would be used to diagnose PCOS and cases will be selected based on it.
- •Criteria for the diagnosis of PCOS would include oligo-ovulation cycles longer than 35 days or less than 26 days, elevated free testosterone levels (0.5 ng/dl; the cutof level for free testosterone level was the mean±2 SD according to normal levels in controls), oligomenorrhea or amenorrhea.
- •A Ferriman-Gallwey (FG) score of≥7 would be taken as indicator for the presence of hirsutism. In accordance with the above criteria, polycystic ovary morphology would be determined by transvaginal ultrasonography, which defines PCOS as the presence of 12 or more small (2-9 mm) follicles in each ovary.
- •Control subjects would have no signs of menstrual dysfunction and their androgen levels should be within the normal range, with normal glucose tolerance, and no family history of hirsutism, type 2 diabetes mellitus, and infertility.
排除标准
- •Women with other causes of hyperandrogenism such as hyperprolactinemia, androgen-secreting tumors, Cushing syndrome and nonclassic congenital hyperplasia would be excluded from this study.
结局指标
主要结局
Evaluate the Analysis of DNA methyl transferases
时间窗: 3 YEARS
DNA will be extracted as per the protocol followed routinely in our lab from blood and ovarian tissues.
Evaluate the Analysis of differential mRNA and protein expression of epigenetic markers in ovarian tissues
时间窗: 3 YEARS
Total RNA from ovarian tissue will be extracted using TRIzol reagent according to the manufacturer's instructions (Invitrogen Life Technologies) and reverse transcribed in the presence of random hexamers. Quantitative real-time PCR reactions will be carried out in an ABI 7000 Thermal Cycler (Applied Biosystems) to analyse the expression of epigenetic markers including the androgen regulated miRNAs and their downstream targets.
次要结局
- understand miRNA regulated epigenetic mechanisms(3 YEARS)
研究者
研究点 (2)
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