| CTRI Number |
CTRI/2025/10/096046 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Meditation, Yoga, and the Journey to Parenthood: Can They Improve IVF Results? |
|
Scientific Title of Study
|
A Mindful Path to Parenthood: Evaluating the Impact of Preksha Meditation and Yoga on IVF Outcomes in Infertile Couples - An Open-Label Randomized Controlled Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| none |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neeta Singh |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, Delhi |
| Address |
Department of Obstetrics and Gynaecology Mother and Child Block All India Institute of Medical Sciences Ansari Nagar New-Delhi
South
DELHI
110029
India |
| Phone |
9818506855 |
| Fax |
|
| Email |
drneetasingh@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeta Singh |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, Delhi |
| Address |
Department of Obstetrics and Gynaecology Mother and Child Block All India Institute of Medical Sciences Ansari Nagar New-Delhi
Central
DELHI
110029
India |
| Phone |
9818506855 |
| Fax |
|
| Email |
drneetasingh@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeta Singh |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, Delhi |
| Address |
Department of Obstetrics and Gynaecology Mother and Child Block All India Institute of Medical Sciences Ansari Nagar New-Delhi
Central
DELHI
110029
India |
| Phone |
9818506855 |
| Fax |
|
| Email |
drneetasingh@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences, New Delhi |
| Address |
All India Institute Of Medical Sciences, New Delhi, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 |
| 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 |
| Dr Neeta Singh |
All India Institute of Medical Sciences |
Department of Obstetrics and Gynaecology Mother and Child Block All India Institute of Medical Sciences Ansari Nagar New-Delhi
Department of Obstetrics and Gynaecology Mother and Child Block All India Institute of Medical Sciences Ansari Nagar New-Delhi
South
DELHI |
09818506855
drneetasingh@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, All India Institute of Medical Sciences, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N979||Female infertility, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional infertility treatment |
12 weeks |
| Intervention |
Yoga and meditation and Conventional treatment for 12 weeks |
12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Mild male factor infertility, anovulation, unexplained infertility, PCOS, tubal factor.
2. Currently seeking fertility treatment at AIIMS, New Delhi.
3. No prior experience with yoga or meditation.
4. Female partner has a BMI less than or qual to 30.
5. No significant medical comorbidities.
|
|
| ExclusionCriteria |
| Details |
1. Not willing to give written informed consent
2. Medical or surgical contraindications to yoga
3. Inability to commit to regular yoga and meditation sessions
4. Morbid obesity in woman
5. Severe endometriosis
6. Prior ovarian surgeries
7. Diabetes Mellitus
8. Autoimmune disorder
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the impact of yoga and meditation on stress and anxiety in infertile couples undergoing IVF. |
Psychological distress will be measured using the DASS-21 and ERQ at Baseline (Week 0) and at end of intervention i.e., 12 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
A. To evaluate the effect of yoga on reproductive health markers in women, including menstrual cycle regularity, ovulation, follicular development, & endometrial thickness.
B. To assess changes in male fertility parameters, including semen quality & biochemical markers.
C. To measure improvements in IVF outcomes, including:
1. number an quality of oocytes,
2. embryo number,
3. fertilization rate,
4. implantation rate, &
5. clinical pregnancy rate.
|
Timepoints: Baseline (Week 0) & at end of intervention i.e., 12 week
IVF success indicators, including oocyte quality, embryo grading, & pregnancy rates, will be monitored over 12 weeks. Statistical analysis (Python, ANOVA, regression modeling) will determine the efficacy of the intervention.
|
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
27/10/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Infertility affects millions of couples worldwide, with 15–25 million in India alone. While In Vitro Fertilization (IVF) is a common assisted reproductive technology, its success is often hindered by high stress levels that negatively impact hormonal balance and reproductive health. This study investigates whether yoga and meditation can reduce psychological stress and enhance IVF outcomes. Grounded in scientific evidence showing the stress-lowering and hormone-regulating effects of mind-body practices, the research employs a randomized controlled trial with 140 infertile couples. Participants in the intervention group will undergo a 12-week guided yoga and meditation program alongside IVF treatment, while a control group receives standard care. The intervention includes physical postures, breathing techniques, and meditation aimed at improving hormonal profiles, menstrual regularity, and endometrial receptivity. Psychological assessments (DASS-21, ERQ) and clinical fertility markers (e.g., oocyte retrieval, implantation rate, hormonal levels) will be evaluated before and after the program. The study hypothesizes that yoga and meditation will significantly reduce anxiety and depression, improve reproductive health parameters, and increase IVF success rates. If proven effective, this integrative approach could be adopted as a cost-effective, non-invasive adjunct therapy to conventional fertility treatments. Long-term plans include expanding the research to assess live birth rates and exploring the impact of mind-body practices on the gut microbiome and epigenetic changes in fertility. |