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CTRI Number  CTRI/2019/04/018421 [Registered on: 04/04/2019] Trial Registered Prospectively
Last Modified On: 02/04/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy
Other (Specify) [Yoga Package]  
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Effect of Yoga on emotional health of infertile women with hormonal disorders related to ovary( Polycystic Ovary Syndrome) 
Scientific Title of Study   Effect of Yoga on Physical and emotional health of infertile women with Polycystic Ovary Syndrome(PCOS) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrAnushree D Patil 
Designation  Scientist D, Gynaecologist 
Affiliation  National Institute for Research in Reproductive Health (NIRRH) 
Address  Department of Clinical Research 1. ICMR-National Institute for Research in Reproductive Health (NIRRH) J.M. Street, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224192028  
Fax  02224139412  
Email  anushreedp123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrAnushree D Patil 
Designation  Scientist D, Gynaecologist 
Affiliation  National Institute for Research in Reproductive Health (NIRRH) 
Address  Department of Clinical Research 1. ICMR-National Institute for Research in Reproductive Health (NIRRH) J.M. Street, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224192028  
Fax  02224139412  
Email  anushreedp123@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Beena Joshi 
Designation  Scientist E 
Affiliation  National Institute for Research in Reproductive Health (NIRRH) 
Address  Department of Operational Research . ICMR-National Institute for Research in Reproductive Health (NIRRH) J.M. Street, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224192043  
Fax  02224139412  
Email  joshib@nirrh.res.in  
 
Source of Monetary or Material Support  
Department of Science and Technology, Technology Bhavan, New Mehrauli road New Delhi-110016 
 
Primary Sponsor  
Name  Department of Science and Technology 
Address  Department of Science and Technology, Technology Bhavan, New Mehrauli road New 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 
Dr Anushree Patil  ICMR- National Institute for Research in reproductive Health  ICMR-National Institute for Research in Reproductive Health, Jehangir Merwanji Street, Parel, Mumbai-400 012
Mumbai
MAHARASHTRA 		 02224192028

anushreedp123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIRRH Ethics Committee for Clinical Studies  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z319||Encounter for procreative management, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Infertile women with PCOS, who are not doing the Yoga intervention as administered to the Intervention group  Infertile women with PCOS, who are not doing the Yoga intervention as administered to the Intervention group 
Intervention  Yoga Package  Specific Yoga module for women with PCOS is prepared. Yoga Intervention will be given thrice a week for 12 weeks. Outcome in terms of pre and post intervention improvement in emotional well being, improvement in physical, endocrine, biochemical parameters, ovulation at end of 12 weeks will be assessed.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1.Infertile women with PCOS(Age 18 – 45 years)
2.Not on medication like oral contraceptive pills, metformin at time of baseline investigation
3.Willing to participate in the study.
4.Assuring to comply with the 12 week intervention
 
 
ExclusionCriteria 
Details  1. Not willing to participate in study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Outcome measures will be pre and post intervention change in psychological status assessed by emotional health scales, physical status assessed by Body mass composition, BMI, waist hip ratio at the end of 12 weeks of Yoga intervention.  At the end of 12 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Ovulation, endocrine and metabolic status assessed by hormonal and biochemical parameters at the end of 12 weeks of Yoga intervention  At the end of 12 weeks  
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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   Phase 2 
Date of First Enrollment (India)   05/04/2019 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Introduction:

Polycystic ovarian syndrome (PCOS) is the most prevalent female endocrine disorder with estimates ranging from 2.2% to as high as 26%. More than 50% of women with PCOS are obese and need lifestyle interventions. Studies prove that PCOS women show high prevalence of anxiety, depressive disorders and suicide attempts. Also women with PCOS suffering from infertility are under tremendous psychological stress which has a vicious effect on the treatment results as well.

Rationale:

Yoga therapy mainly improves reproductive functions by reducing stress and balancing the neurohormonal profile. To the best of our knowledge there are no published research studies on the effect of Yoga on physical and emotional well being among infertile women with PCOS.

Study design Hence we wish to undertake this prospective intervention study to understand the effect of Yoga on physical and emotional well being of infertile women with Polycystic Ovary Syndrome (PCOS) with following

Objectives:

  1. To implement yoga as an integral component in our multidisciplinary approach among infertile women with PCOS.
  2. To study the effect of guided Yoga intervention on physical and emotional well being of infertile women with PCOS.
  3. To understand the acceptability, barriers and facilitating factors for introducing Yoga intervention in this group.

Methodology:

This will be a Joint collaboration between NIRRH and Kaivalyadham Institute of Yoga.

140 Infertile women with PCOS from NIRRH PCOS clinic will be recruited for the study (70 intervention group and 70 control).Pre and Post Estimation of following parameters will be done as mentioned below.

 

Emotional well being: PCOS-Q, Anxiety Depression scales, Body image issues, eating habits, sleep pattern

Clinical (height, weight, BMI, Waist-hip ratio, B. P, FG score, acne, acanthosis nigricans)

Ultrasound pelvis and abdomen (for PCOS, Non alcoholic Fatty Liver and cholelithiasis)

Hormonal tests (TSH, Prolactin, LH, FSH, testosterone, SHBG, 17-OHP, Vitamin D, s.AMH s.Cortisol)       

Metabolic tests (75g OGTT, Insulin, Lipid profile)

Specific Yoga module for women with PCOS will be prepared. Yoga Intervention will be given thrice a week for 12 weeks.

Outcome in terms of pre and post intervention improvement in emotional well being, improvement in physical, endocrine, biochemical parameters, ovulation at end of 12 weeks will be assessed.

Utilisation of outcome

Findings from this study will be used to plan future implementation research to upscale Yoga intervention among infertile women with PCOS across India through medical colleges of NIRRH field units in collaboration with Kaivalyadham and AYUSH.

 

Key words: PCOS, Infertile women, Yoga

 

 
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