Mapping Heterogeneity in Polycystic Ovarian Syndrome: Integrating Clinical, Endocrinological, Body Composition Analysis and Vagosympathetic Tone - A Prospective Case Control study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- vagosympathetic balance and HRV parameters in PCOS and Non PCOS patients.
研究概览
简要总结
Polycystic Ovary Syndrome (PCOS) is a multifaceted endocrine disorder affecting millions of individuals worldwide, characterized by its clinical heterogeneity.[1] Current diagnostic modality, Rotterdam Criteria, primarily relies upon clinical symptoms, hormonal imbalances (hyperandrogenism), and ultrasound findings.[2] However, this criterion often falls short in capturing the full spectrum of PCOS manifestations in various phenotypic subgroups. Recognizing the need for a more precise phenotypic classification system, there is a growing consensus that such a system is essential for gaining a deeper understanding of the condition, predicting its clinical trajectory, and tailoring interventions more effectively. While previous research has separately delved into PCOS from hormonal and metabolic perspectives, there has been a conspicuous absence of a comprehensive exploration into the connections between PCOS phenotypes, body composition, hormonal profiles, and vagosympathetic balance. This study seeks to bridge this critical knowledge gap by simultaneously employing advanced body composition analysis techniques [3-6], incorporating recent endocrine biomarkers like Anti-Müllerian Hormone (AMH) [7], and assessing vagosympathetic balance [5] to reclassify individuals with PCOS. The outcomes of this research will illuminate the heterogeneity of PCOS [8-10] and contribute to the development of more personalized diagnostic and therapeutic strategies, ultimately leading to improved patient outcomes.
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 45.00 Year(s)(—)
- 性别
- Female
入选标准
- •The control group will be recruited from following inclusion criteria: a.
- •Women between age 18–45 years b.
- •Normo-androgenic Women (Absence of hirsutism) c.
- •With history of regular, ovulatory menstrual cycles d.
- •(The diagnosis of PCOS will be based on 2003 Rotterdam ESHRE/ASRM PCOS Consensus Workshop Group diagnostic criteria.).
排除标准
- •Exclusion criteria includes: a.
- •Hyperandrogenism (Cushing’s syndrome (based on history taking and physical examination, Late-onset congenital adrenal hyperplasia (by estimating the serum levels of 17-hydroxyprogesterone).
- •Pregnant and breastfeeding women c.
- •Patient on medications (Medications for Diabetes, Hypo/Hyperthyroidism, Dyslipidaemia, Hyperprolactinemia) d.
- •Chronic or acute pelvic infection (Within the previous 30 days), any other serious medical problem e.
- •Hormonal contraception and/or Anti-androgen therapy (Within the previous 6 months) f.
- •Patients not willing or able to give informed consent.
结局指标
主要结局
vagosympathetic balance and HRV parameters in PCOS and Non PCOS patients.
时间窗: HRV will be done after confirmation PCOS by clinical examinations and Hormonal Profile, only once during the study after recruitment.
次要结局
- Corelation between different sub-types of PCOS with HRV & hormonal profiles(At Baseline.)
研究者
Dr Medhavi Sharma
All India Institute of Medical Sciences, Rajkot
