| 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
|
|
|
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
|
|
|
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). |