Comparison of Yoga-Integrated Therapy and Standard Medical Management on Ovulation Outcomes in Women with Polycystic Ovary Syndrome: A Randomised Control Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- PRIMARY OUTCOME:
研究概览
简要总结
Polycystic ovarian syndrome being an endocrine disorder is the most common cause for infertility in reproductive age females While pharmacological therapies for PCOS primarily focus on ovulation induction they often fall short in addressing the broader metabolic and emotional needs YIT offers a holistic alternative that targets these multifaceted concerns Evidence suggests that yoga can improve insulin sensitivity regulate hormonal imbalances reduce stress improve cardiometabolic outcomes and enhance overall wellbeing factors that are directly implicated in the pathology of PCOS There is a paucity of data evaluating yoga as an adjunct therapy to improve ovulation rates in infertile women with PCOS while also addressing metabolic, hormonal, and psychological health in infertile Indian women. This study aims to fill that gap by assessing the effectiveness of structured yoga intervention alongside standard treatment providing a cost effective holistic approach for improving ovulation rates in Indian infertile females with PCOS
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 19.00 Year(s) 至 38.00 Year(s)（—）
- 性别
- Female
入选标准
- •Infertile women aged between 19 and 38 years & diagnosed with PCOS as per Rotterdam Criteria Willingness and ability to participate in the structured yoga intervention program for the entire study duration.
- •Possession of a smartphone with internet access for regular follow-up reminders and compliance monitoring Willingness to comply with study procedures, including regular attendance at yoga sessions and follow up visits.
排除标准
- •Known cases of chronic systemic illnesses, such as cerebrovascular diseases, thyroid disorders cardiovascular diseases, or any other severe systemic illness & physical disorders that would interfere with study participation or compliance Presence of tubal factor and/or male factor infertility and poor ovarian reserve Women who have received ovulation induction drugs within the last three months prior to recruitment History of recurrent pregnancy loss, defined as two or more consecutive spontaneous miscarriages Prior regular practice of structured physical exercise programs, example regular workouts or yoga or meditation within the last six months.
结局指标
主要结局
PRIMARY OUTCOME:
时间窗: At baseline and after 12weeks period
OUTCOME VARIABLES:
时间窗: At baseline and after 12weeks period
Proportion of infertile women with PCOS who ovulate in two groups receiving structured yoga plus standard
时间窗: At baseline and after 12weeks period
treatment versus standard treatment alone using TVUS follicular monitoring and Day-21 Progesterone levels
时间窗: At baseline and after 12weeks period
次要结局
- Menstrual Cycle changes(Cardiometabolic parameter changes)
研究者
Dr Sommya Naberia
Lady Hardinge Medical College