A Mindful Path to Parenthood: Evaluating the Impact of Preksha Meditation and Yoga on IVF Outcomes in Infertile Couples - An Open-Label Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- To assess the impact of yoga and meditation on stress and anxiety in infertile couples undergoing IVF.
研究概览
简要总结
Infertility affects millions of couples worldwide, with 15–25 million in India alone. While In Vitro Fertilization (IVF) is a common assisted reproductive technology, its success is often hindered by high stress levels that negatively impact hormonal balance and reproductive health. This study investigates whether yoga and meditation can reduce psychological stress and enhance IVF outcomes. Grounded in scientific evidence showing the stress-lowering and hormone-regulating effects of mind-body practices, the research employs a randomized controlled trial with 140 infertile couples. Participants in the intervention group will undergo a 12-week guided yoga and meditation program alongside IVF treatment, while a control group receives standard care. The intervention includes physical postures, breathing techniques, and meditation aimed at improving hormonal profiles, menstrual regularity, and endometrial receptivity. Psychological assessments (DASS-21, ERQ) and clinical fertility markers (e.g., oocyte retrieval, implantation rate, hormonal levels) will be evaluated before and after the program. The study hypothesizes that yoga and meditation will significantly reduce anxiety and depression, improve reproductive health parameters, and increase IVF success rates. If proven effective, this integrative approach could be adopted as a cost-effective, non-invasive adjunct therapy to conventional fertility treatments. Long-term plans include expanding the research to assess live birth rates and exploring the impact of mind-body practices on the gut microbiome and epigenetic changes in fertility.
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
- All
入选标准
- •Mild male factor infertility, anovulation, unexplained infertility, PCOS, tubal factor.
- •Currently seeking fertility treatment at AIIMS, New Delhi.
- •No prior experience with yoga or meditation.
- •Female partner has a BMI less than or qual to
- •No significant medical comorbidities.
排除标准
- •Not willing to give written informed consent
- •Medical or surgical contraindications to yoga
- •Inability to commit to regular yoga and meditation sessions
- •Morbid obesity in woman
- •Severe endometriosis
- •Prior ovarian surgeries
- •Diabetes Mellitus
- •Autoimmune disorder.
结局指标
主要结局
To assess the impact of yoga and meditation on stress and anxiety in infertile couples undergoing IVF.
时间窗: Psychological distress will be measured using the DASS-21 and ERQ at Baseline (Week 0) and at end of intervention i.e., 12 week
次要结局
- A. To evaluate the effect of yoga on reproductive health markers in women, including menstrual cycle regularity, ovulation, follicular development, & endometrial thickness.(B. To assess changes in male fertility parameters, including semen quality & biochemical markers.)
研究者
Dr Neeta Singh
All India Institute of Medical Sciences, Delhi
