Evaluation of Salivary microRNA-21 in Polycystic Ovarian Syndrome (PCOS) Patients using RT-PCR – A Baseline Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To evaluate the differential expression of salivary microRNA-21 in Polycystic Ovarian Syndrome (PCOS) patients compared to healthy controls, establishing its potential as a non-invasive diagnostic biomarker.
研究概览
简要总结
Title: Evaluation of Salivary microRNA-21 in Polycystic Ovarian Syndrome (PCOS) Patients Using RT-qPCR – A Baseline Study
Objective: This study aims to explore the potential of salivary microRNA-21 as a non-invasive biomarker for diagnosing PCOS. By evaluating and comparing its expression levels in PCOS patients and healthy individuals, the study seeks to establish the diagnostic utility of salivary microRNA-21.
Methodology:
- Design: Cross-sectional study over 2 years.
- Population: 100 participants (50 PCOS patients and 50 healthy controls).
- Sampling: Random selection following strict inclusion and exclusion criteria.
- Sample Collection: Unstimulated saliva samples preserved with specialized reagents for RNA extraction.
- Analysis: RNA extraction, reverse transcription to cDNA, and quantification using RT-qPCR. Statistical methods will include t-tests, ANOVA, and ROC curve analysis.
Expected Implications: The research could pave the way for using saliva as a patient-friendly and cost-effective diagnostic sample for PCOS, enabling early intervention and reducing associated morbidities. Additionally, it might advance the field of saliva-based diagnostics for other diseases.
This innovative approach can serve as a benchmark for non-invasive diagnostic techniques in reproductive and systemic health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 30.00 Year(s)（—）
入选标准
- •Volunteering participants Age criteria: 18 to 30 years Patients who are diagnosed with PCOS Gender: Females.
排除标准
- •Patients under treatment for PCOS Controls included any known medical conditions or disease Pregnancy and lactating women.
结局指标
主要结局
To evaluate the differential expression of salivary microRNA-21 in Polycystic Ovarian Syndrome (PCOS) patients compared to healthy controls, establishing its potential as a non-invasive diagnostic biomarker.
时间窗: Baseline (1–6 Months):Collect unstimulated saliva samples from PCOS patients and controls. | 7th Month: | Week 1: Extract microRNA. | Week 2: Quantify and qualify microRNA. | Week 3: Prepare microRNA-21 and RNU6 primers. | Week 4: Convert RNA to cDNA. | 8th Month: | Week 1: Perform RT-qPCR for microRNA-21 expression. | Weeks 2 and 3: Conduct statistical and ROC curve analysis to evaluate diagnostic potential.
次要结局
未报告次要终点
研究者
M ABIRAMI
Karpaga Vinayaga Institute of Dental Sciences