FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/02/031131 [Registered on: 09/02/2021] Trial Registered Prospectively
Last Modified On: 09/12/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Single Arm Study 
Public Title of Study   Effect of Yoga in male infertility 
Scientific Title of Study   Effect of Yoga and Meditation based lifestyle Intervention on spermatozoal transcripts and miRNA in idiopathic infertility and early pregnancy loss 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rima Dada 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  1036, First Floor
Department of Anatomy
South
DELHI
110029
India 
Phone    
Fax    
Email  rima_dada@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rima Dada 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  1036, First Floor
Department of Anatomy
South
DELHI
110029
India 
Phone    
Fax    
Email  rima_dada@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Rima Dada 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  1036, First Floor
Department of Anatomy
South
DELHI
110029
India 
Phone    
Fax    
Email  rima_dada@rediffmail.com  
 
Source of Monetary or Material Support  
SATYAM, Department of Science and technology, India 
 
Primary Sponsor  
Name  DST 
Address  Technology Bhawan, New Mehrauli Road, next to Qutub Hotel, New Delhi, Delhi 110016 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Rima Dada  All India Institute of Medical Sciences, New Delhi  1036, First Floor Department of Anatomy
South
DELHI 
011-26593517

rima_dada@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N469||Male infertility, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Yoga-based lifestyle intervention  Yoga based lifestyle intervention program developed at Integral Health clinic comprises Asanas(physical postures), Pranayama(breathing exercise), Dhayna(Meditation) and counselling and education on healthy lifestyle. 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  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
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
spermatozoal transcripts and miRNA   pre intervention day 0 and post- day 10, day 30 and day 90 
 
Secondary Outcome  
Outcome  TimePoints 
Sperm parameters   pre intervention day 0 and post- day 10, day 30 and day 90 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The stressors in complex modern lifestyle seem to be accelerating and have been proposed to be the contributors to various “lifestyle related” chronic diseases such as depression, heart diseases and diabetes. These have been implicated as one of the causal factors in the etiology of various reproductive disorders like infertility, early pregnancy loss, implantation failures in IVF cycles and congenital malformations due to alarming effects on the health of the future progeny. The paternal contribution has important implications in fertilization and for understanding early developmental process and their effect on outcome of the future progeny. The effects are adverse due to decrease in quality of life and poor response to pharmacologic treatment. The impact of antioxidant on nuclear DNA damage is still controversial. Efforts are underway to find non-pharmacologic therapies to relieve stress and anxiety, and adoption of yoga as an integral part of our lifestyle is a promising beneficial treatment modality. Yoga, the ancient Indian discipline, is aimed at achieving union and harmony between our mind and body, and brings balance to all aspects of one’s being. It is a highly advanced technique for attaining perfect alignment of body and prepare it for meditation.

Since we have already shown in our previously published studies that ROS causes both mitochondrial and nuclear DNA damage hence we propose (in this study) to assess both oxidative stress and oxidative DNA damage in semen (1, 2, 3). Ongoing studies from our laboratory have also shown the beneficial effect of the brief YBLI for 21 days in modifying the gene expression in male partners with couples with 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 oxidative stress, DNA damage, telomere dynamics and gene expression. In the present proposal, we plan to study the effect of lifestyle modifying factors and potential interventions on the sperm integrity and expression of mRNA and miRNAs by enrolling patients for yoga and meditation based lifestyle intervention (YBLI).

 
Close