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CTRI Number  CTRI/2024/03/063678 [Registered on: 06/03/2024] Trial Registered Prospectively
Last Modified On: 29/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Experiences of Couples Achieving Pregnancy with Help of Advanced Fertility Treatments  
Scientific Title of Study   Experiences of couples who have successfully conceived through assisted reproductive technology 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Apoorva Yadav 
Designation  M Phil Trainee 
Affiliation  Manipal College of Health Professions 
Address  Department of Clinical Psychology, 5th floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9310599639  
Fax    
Email  apoorva.mchpmpl2022@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vaishalee S 
Designation  Assistant Professor  
Affiliation  Manipal College of Health Professions 
Address  Department of Clinical Psychology,5th floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9488615322  
Fax    
Email  vaishalee.s@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Apoorva Yadav 
Designation  M Phil Trainee 
Affiliation  Manipal College of Health Professions 
Address  Department of Clinical Psychology, 5th floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9310599639  
Fax    
Email  apoorva.mchpmpl2022@learner.manipal.edu  
 
Source of Monetary or Material Support  
Department of Clinical Psychology, 5th floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka 
 
Primary Sponsor  
Name  Department of Clinical Psychology, MCHP, MAHE 
Address  Department of Clinical Psychology, Kasturba Medical College, MCHP, MAHE, Manipal, Udupi, Karnataka 
Type of Sponsor  Other [Private institution in affiliation with a private hospital] 
 
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 Prashanth Adiga  Kasturba Hospital   Department of Reproductive Medicine and Surgery, Ground floor
Udupi
KARNATAKA 
9035036832

prashanth.adiga@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee 1  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O099||Supervision of high risk pregnancy, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  • Couples who conceived through assisted reproductive technology for primary infertility
• Couples in the first trimester of pregnancy (conception to 13 weeks)
• Couples who are married and living together.
• Couples who are fluent in English and Hindi.
 
 
ExclusionCriteria 
Details  1. History of any diagnosed psychiatric illness.
2. Same-sex couples who have successfully conceived through assisted reproductive technology.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
An understanding of how the ART (Assisted Reproductive Technology) journey impacts couples relationships and emotional well-being.  End of first trimester of pregnancy  
 
Secondary Outcome  
Outcome  TimePoints 
Additional data on how Assisted Reproductive Technology (ART) is to understand how the journey impacts their relationship & emotional well-being.  At the end of first trimester of pregnancy  
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
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)   20/03/2024 
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)   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  

The study titled ’Experiences of couples who have successfully conceived through assisted reproductive technology’ is of Qualitative exploratory design and aims to explore the experiences of couples who have successfully conceived through assisted reproductive technology. The objectives of the study are to gain an in-depth understanding of the psychological experiences of couples during the  treatment process and to understand experiences of couples, their coping mechanisms and challenges faced during the first trimester after successful assisted conception. The rationale for study comes from the fact that there is limited understanding of the experiences of couples who achieve pregnancy through assisted reproductive techniques. While significant clinical evidence indicates women’s challenges, there needs to be more comprehensive empirical research in this area, particularly in understanding the challenges and interpersonal experiences encountered by the couple together. The procedure is as follows. Couples will be interviewed together using a semi-structured interview schedule developed by the researcher and validated by subject experts. The interviews are expected to last 45 minutes to 1 hour and will be conducted in a private and distraction-free environment with adequate breaks when necessary. Audio recordings of the interviews will be taken after obtaining consent from the participants, and the reporting of data will ensure anonymity. Qualitative data would be analysed using Braun and Clarke’s thematic analysis method (2006). 

 
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