跳至主要内容
临床试验/CTRI/2021/02/031131
CTRI/2021/02/031131招募中不适用

Effect of Yoga and Meditation based lifestyle Intervention on spermatozoal transcripts and miRNA in idiopathic infertility and early pregnancy loss

DST1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年1月3日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
spermatozoal transcripts and miRNA

研究概览

简要总结

The stressors in complexmodern lifestyle seem to be accelerating and have been proposed to be thecontributors to various “lifestyle related†chronic diseases such asdepression, heart diseases and diabetes. These have been implicated as one ofthe causal factors in the etiology of various reproductive disorders likeinfertility, early pregnancy loss, implantation failures in IVF cycles andcongenital malformations due to alarming effects on the health of the futureprogeny. The paternal contribution has important implications in fertilizationand for understanding early developmental process and their effect on outcomeof the future progeny. The effects are adverse due to decrease in quality oflife and poor response to pharmacologic treatment. The impact of antioxidant onnuclear DNA damage is still controversial. Efforts are underway to findnon-pharmacologic therapies to relieve stress and anxiety, and adoption of yogaas an integral part of our lifestyle is a promising beneficial treatmentmodality. Yoga, the ancient Indian discipline, is aimed at achieving union andharmony between our mind and body, and brings balance to all aspects of one’sbeing. It is a highly advanced technique for attaining perfect alignment ofbody and prepare it for meditation.

Since we havealready shown in our previously published studies that ROS causes bothmitochondrial and nuclear DNA damage hence we propose (in this study) to assessboth oxidative stress and oxidative DNA damage in semen (1, 2, 3). Ongoingstudies from our laboratory have also shown the beneficial effect of the briefYBLI for 21 days in modifying the gene expression in male partners with coupleswith recurrent implantation failure as well as recurrent pregnancy loss (4).The effect of quitting smoking, alcohol intake, deep breathing (Pranayama)along with modifying factors of lifestyle interventions like “Yoga†and“Meditation†can, therefore, be evaluated by the measurement of oxidativestress, DNA damage, telomere dynamics and gene expression. In the presentproposal, we plan to study the effect of lifestyle modifying factors andpotential interventions on the sperm integrity and expression of mRNA andmiRNAs by enrolling patients for yoga and meditation based lifestyleintervention (YBLI).

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
21.00 Year(s) 至 45.00 Year(s)(—)
性别
Male

入选标准

  • a.Group I- idiopathic primary infertility b.Group II- Male partners of couples with >2 pregnancy losses c.Group III- Male partners of couples with >2 implantation failures in IVF cycles d.Age <45 years e.Willing to attend full course of intervention f.Conversant in Hindi and/or English.

排除标准

  • a.Refusal to participate in study b.Recent history of any febrile illness, inflammatory disorders c.History of drug intake in the last 3 months d.Patients on any co-morbid medical conditions e.
  • Patients with any abnormal chromosomal complement.

结局指标

主要结局

spermatozoal transcripts and miRNA

时间窗: pre intervention day 0 and post- day 10, day 30 and day 90

次要结局

  • Sperm parameters(pre intervention day 0 and post- day 10, day 30 and day 90)

研究者

发起方
DST
申办方类型
Government funding agency

研究点 (1)

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