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CTRI Number  CTRI/2024/01/061753 [Registered on: 23/01/2024] Trial Registered Prospectively
Last Modified On: 17/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy
Process of Care Changes
Behavioral 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Efficacy of mind-body therapy on couples going through Frozen Embryo Transfer 
Scientific Title of Study   Efficacy of mind body augmentation therapy on FET couples 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
SPL/CA/092022/V.01  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vidya V Bhat 
Designation  Medical Director 
Affiliation  Radhakrishna Multispeciality Hospital and IVF Center 
Address  3-4 Sunrise Towers, JP road, opp. Canara Bank, 1st phase Girinager, Banashankri, Bangalore

Bangalore
KARNATAKA
560085
India 
Phone  96631060764  
Fax    
Email  vidyabhat68@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Rayana Rose Sabu 
Designation  Behavioural Health Coach/ CT Monitor 
Affiliation  Sparcolife Digital Healthcare Technologies Private Limited 
Address  No.24, 15 th Main 6 th Cross , RK Layout , Padmanabhanagar , Bangalore -

Bangalore
KARNATAKA
560070
India 
Phone  7899321494  
Fax    
Email  rayana@vyli.health  
 
Details of Contact Person
Public Query  
Name  Meghana Siva 
Designation  Clinical Research Coordinator 
Affiliation  Sparcolife Digital Healthcare Technologies Private Limited 
Address  No.24, 15 th Main 6 th Cross , RK Layout , Padmanabhanagar , Bangalore

Bangalore
KARNATAKA
560070
India 
Phone  9663224176  
Fax    
Email  meghana@vyli.health  
 
Source of Monetary or Material Support  
Radhakrishna Multispeciality Hospital and IVF Center 
Sparcolife Digital Healthcare Technologies Pvt Ltd 
 
Primary Sponsor  
Name  Sparcolife Digital Healthcare Technologies Pvt Ltd 
Address  Care of Foundation for sandbox startup initiatives , Gokul road , next to international airport , opp Gokul , Gokul village , Hubballi – 580030 , Karnataka  
Type of Sponsor  Other [Healthcare] 
 
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 Vidya V Bhat  Radhakrishna Multispeciality Hospital and IVF Center  3-4 Sunrise Towers, JP road, opp. Canara Bank, 1st phase Girinager, Banashankri, Bangalore - 560085
Bangalore
KARNATAKA 		 9663160764

vidyabhat68@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACE Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z317||Encounter for procreative management and counseling for gestational carrier,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Comprehensive Psychosocial Health Intervention  The current interventional study is designed to provide comprehensive psychotherapy for reducing treatment distress and coping with infertility, Yoga/mindfulness exercises for increasing mindfulness and reducing rumination while inducing hormonal balance. Nutrition & diet-specific sessions improve physical health while undergoing Frozen embryo transfer. The duration of the intervention will be 4 weeks i.e. 1 month, with 12 session conducted digitally. The total duration of the trial will be 3 months comprising of 14 couples in the interventional group. The interventions are administered by fertility experts, clinical psychologists, yoga experts and clinical nutritionists experienced in handling individuals suffering from fertility issues. 
Comparator Agent  Without Comprehensive Psychosocial Health Intervention  14 Couples undergoing Frozen Embryo Transfer with standard medical treatment/guidelines without any psychosocial intervention, will be in the trial for 3 months as control group for comparative study. 
 
Inclusion Criteria  
Age From  27.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Provision of signed and dated informed consent form.
2. Willingness to adhere to the study intervention regimen.
3. Known cases of infertility diagnosed with Primary infertility and Secondary infertility.
4. Diagnosed with Female/male/combined/idiopathic infertility.
5. Age range: both partners range- 27-45 years.
6. Undergoing frozen embryo transfer (IVF) after approval from a medical doctor.
7. Only subjects whose ET is scheduled for at least 25 days later should be registered. Or more than three days after registration, the menstrual cycle is about to begin
8. The couples enrolling for the study should be English Speaking.
9. Access necessary resources for a technology-based intervention (i.e., computer, smartphone, internet access)
10. Psychiatric Severity: Mild to moderate (Hamilton Depression Rating Scale score ≤ 16, Hamilton Anxiety Rating Scale (HAM-A) score ≤ 24, and not reporting any current suicidal ideation or intent) 
 
ExclusionCriteria 
Details  Not having consent from both partners or meeting the inclusion criteria
Age of any partner above 45 years and below 27 years
History of Severe Psychiatric Conditions as screened by a Registered Clinical Psychologist or Psychiatrist
Couples opting for Surrogacy
Any event medical condition or situation such that continued collection of follow-up study data would not be in the participants best interest or might require an additional treatment that would confound the interpretation of the study
Treatment with another investigational drug or other intervention within the first 6 months
Current smoker or tobacco use within 1 month 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Increasing conception chances of couples undergoing infertility treatment in the Interventional group compared to the Control Group   7 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Mitigating stress anxiety & emotional dysregulation among infertility treatment couples
Improvement in Physical health & quality of life
Improvement in quality of sleep or severity of insomnia
Improvement in mindfulness  		 8 Weeks 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
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)   29/01/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   The present prospective single-centre clinical trial seeks to evaluate the efficacy of a mind-body therapy treatments programme for stress management, anxiety, coping, and emotion regulation in infertility-treated couples (Frozen embryo transfer). In this paper, we will examine each scientific phase of clinical research in detail. Over the course of three months, baseline and post-test findings would be obtained from both the experimental (N=14) and control (N=14) groups. This study is a pragmatic, randomised, controlled experiment with parallel groups. This study examines the efficacy of the experimental biopsychosocial/mind-body therapeutic programme in reducing stress, uncertainty, and anxiety associated with infertility treatment (Frozen embryo transfer). The study is a 3-month parallel-group RCT with two arms-randomly assigned subjects to the experimental and control groups (1:1). The randomization will be stratified by age to ensure that intervention and control groups are equally distributed across all age groups. The results would demonstrate the efficacy of a mind-body/biopsychosocial therapy treatment programme in conjunction with FET. 
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