| 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
|
|
|
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
|
|
|
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). |