| CTRI Number |
CTRI/2024/06/068781 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Yoga therapy in Infertile women for easing Anxiety, Depression and Boosting IVF/ICSI Cycle Success |
|
Scientific Title of Study
|
Effectiveness Of Yoga In Reducing Anxiety And Depression And Its Impact on Reproductive Outcome In Women Undergoing IVF/ICSI: Randomized Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neeta Singh |
| Designation |
Professor |
| Affiliation |
AIIMS |
| Address |
Room 709, Department of Obstetrics and Gynaecology, Mother and Child Block, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
9818506855 |
| Fax |
|
| Email |
drneetasingh@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nisha |
| Designation |
Resident |
| Affiliation |
AIIMS |
| Address |
Room 3, ART centre, Department of Obstetrics and Gynaecology, Mother and Child Block, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
8606189624 |
| Fax |
|
| Email |
nisharao.gudiya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nisha |
| Designation |
Resident |
| Affiliation |
AIIMS |
| Address |
Room 3, ART centre, Department of Obstetrics and Gynaecology, Mother and Child Block, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
8606189624 |
| Fax |
|
| Email |
nisharao.gudiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room 3, ART Centre, Department of Obstetrics and gynaecology, All India Institute of Medical Sciences, New Delhi, Pin code 110029 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 |
| Professor Neeta Singh |
All India Institute of Medical Sciences |
Room 3, ART centre, Department of Obstetrics and Gynaecology, Mother and Child Block, All India Institute of Medical Sciences, New Delhi
South
DELHI |
9818506855
drneetasingh@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Infertility |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Preventive therapy (yoga) |
12 sessions of yoga therapy will be given over 6weeks before starting IVF/ICSI Cycle in infertile women |
|
|
Inclusion Criteria
|
| Age From |
23.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
All women between age group of 23 to 40 years undergoing IVF at Art centre and willing to participate |
|
| ExclusionCriteria |
| Details |
Comorbid psychiatric illness, substance abuse, opting for pharmacotherapy in view of anxiety or depression, donor recipient cycles |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of yoga on clinical pregnancy rate in infertile women with anxiety and depression undergoing IVF/ICSI cycles |
Assess at 6weeks of pregnancy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the anxiety levels by using Beck Anxiety Inventory (BAI)questionnaire pre & post yoga sessions, to assess the depression level by using HAM-D questionnaire pre & post yoga sessions, to assess the quality of life by using Fertility Quality of Life (FertiQol) questionnaire pre & post yoga sessions, Comparison of Oocyte & Embryo quality among the treated & control groups, Implantation rate among the treated & control group |
At day 3 of embryo, at day 5 of embryo & after 2weeks of embryo transfer |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3 |
|
Date of First Enrollment (India)
|
08/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
08/07/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This is a trial of yoga therapy on infertile women undergoing IVF/ICSI cycles who are suffering from anxiety and depression. for this trial recruitment is not yet started. |