Investigating the Role of Follicular Fluid microRNAs in Ovarian Aging and Assisted Reproductive Success
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Identify exosomal miRNAs using RNA sequencing
研究概览
简要总结
The purpose of this study is to investigate the role of exosomal microRNAs (miRNAs) in follicular fluid (FF) as biomarkers of ovarian aging and predictors of in vitro fertilization (IVF) outcomes. The goal is to identify noninvasive molecular markers that correlate with oocyte quality and reproductive potential, particularly in women of advanced maternal age.
详细描述
There is a substantial gap in understanding how these miRNAs operate in humans, especially in a non-invasive or minimally invasive context.
Specifically:
- The role of exosomal miRNAs in follicular fluid (FF) in human ovarian aging is not well defined.
- Few studies have directly compared miRNA expression profiles in FF across age groups using high-throughput sequencing.
- There is limited evidence linking specific FF miRNAs to oocyte quality or IVF success rates.
- No validated non-invasive biomarkers based on FF exosomal miRNA currently exist for predicting IVF outcomes, especially in women of advanced reproductive age.
This study seeks to address these knowledge gaps by identifying and validating exosomal miRNA signatures in FF that are associated with maternal age and IVF outcomes. The most relevant preliminary data come from preclinical rodent studies performed by our research team:
- miRNA profiling in aged vs. young mouse ovarian tissues demonstrated clear age-associated changes in miRNA expression.
- Gene target analyses revealed that these miRNAs are likely to regulate critical signaling pathways involved in ovarian aging (e.g., FoxO, mTOR, PI3k/Akt).
- These results support the biological plausibility that similar miRNA changes could occur in human follicular environments and impact oocyte competence.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women undergoing IVF treatment due to male factor infertility or nonovarian causes.
- •Age groups: younger women <31 years and older women >38 years.
- •Regular menstrual cycles.
- •Willing and able to provide informed consent.
排除标准
- •Minors (under 18 years) and women aged 32-37 years
- •Diagnosis of polycystic ovarian syndrome (PCOS).
- •History of recurrent pregnancy loss.
- •Presence of endometriosis.
- •Diagnosis of ovarian insufficiency.
- •Metabolic disorders (e.g., diabetes).
- •History of ovarian surgery or chemotherapy.
- •Any condition that might impact follicular fluid quality or IVF outcomes.
结局指标
主要结局
Identify exosomal miRNAs using RNA sequencing
时间窗: 1 year
Identify differentially expressed exosomal miRNAs in the follicular fluid of younger (\<31 years) versus older (\>38 years) women undergoing IVF using small RNA sequencing.
Validate and assess miRNA for IVF
时间窗: 1 year
Validate the expression of selected miRNAs in an independent sample set and assess their correlation with clinical IVF parameters, including oocyte maturity, fertilization, and embryo development.
Determine molecular pathways regulated by age
时间窗: 1 year
Use bioinformatic analysis and in vitro functional assays to determine the molecular pathways regulated by age associated miRNAs, particularly those involved in follicular development, hormone signaling, and cellular aging.
次要结局
未报告次要终点