| CTRI Number |
CTRI/2025/06/088103 [Registered on: 02/06/2025] Trial Registered Prospectively |
| Last Modified On: |
16/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To see the effects of yoga on stress and reproduction in women with infertility |
|
Scientific Title of Study
|
Exploring the psychological and reproductive benefits of yoga for women with infertility |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rutuja Tijare |
| Designation |
Junior resident |
| Affiliation |
Postgraduate institute of medical education and research |
| Address |
Department of obstetrics and gynaecology
3rd floor nehru hospital
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9156148395 |
| Fax |
|
| Email |
tijarerutuja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Doctor sujata siwatch |
| Designation |
Additional professor |
| Affiliation |
Postgraduate institute of medical education and research |
| Address |
Department of obstetrics and gynaecology
Third floor nehru hospital
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087008007 |
| Fax |
|
| Email |
sujatasiw@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Rutuja Tijare |
| Designation |
Junior resident |
| Affiliation |
Postgraduate institute of medical education and research |
| Address |
Department of obstetrics and gynaecology
Third floor nehru hospital
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9156148395 |
| Fax |
|
| Email |
tijarerutuja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Collaborative center for mind body intervention through yoga |
|
|
Primary Sponsor
|
| Name |
Pgimer chandigarh |
| Address |
Pgimer chandigarh India 160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Rutuja Tijare |
Nehru hospital PGIMER |
Department of obstetrics and gynaecology third floor nehru hospital
Chandigarh
CHANDIGARH |
09156148395
tijarerutuja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee pgimer chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Women with infertility not performing any yogic exercises |
Women with infertility in control group will receive only standard treatment for infertility |
| Intervention |
Yoga exercise |
Women with infertility in case group will perform yoga exercise for 3 months along with standard treatment for infertility and women in control group will receive only standard treatment for infertility |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Women within age group of 20-40 years with infertility (primary and secondary) attributed to polycystic ovarian disease or unexplained infertility.
Willing to participate in the study
Not performing any kind of yogic exercises
|
|
| ExclusionCriteria |
| Details |
Not willing to participate in the study
Women with infertility already performing yogic exercises
Women with infertility due to tubal block or severe male factor infertility (and not intending to use male donor gametes)
Women with known psychiatric illness/ substance abuse
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Benefits of yoga on stress |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effects on yoga on anxiety, depression & reproductive outcome in women with infertility |
12 weeks |
| Effect of yoga on reproductive outcome |
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/06/2025 |
| Date of Study Completion (India) |
19/06/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
19/06/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Infertility is associated with stress, anxiety and depression due with heightened social, sexual and relationship concern which in turn perpetuates infertility. Health benefits of yoga include reducing stress, anxiety, depression, chronic pain syndromes and chronic conditions.In this study, we intend to assess the impact of yoga on infertility related stress and mental health and simultaneously its correlation with biochemical markers and clinical outcome.
|