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CTRI Number  CTRI/2024/04/065705 [Registered on: 15/04/2024] Trial Registered Prospectively
Last Modified On: 12/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study conducted in a rural tertiary care hospital on the quality of life (QoL) and factors influencing women who have had unsuccessful IVF treatments in the past. 
Scientific Title of Study   A cross sectional study of the fertility of life(QOL) and the factors that impact women with previous failed IVF treatment in rural tertiary care hospital. 
Trial Acronym  nil  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prerna 
Designation  IVF fellow 
Affiliation  Jawaharlal Nehru Medical College , DMIHER  
Address  Room no 11,IVF LAB , AVBR Hospital
JNMC , sawangi ( meghe ), Wardha, Maharashtra
Wardha
MAHARASHTRA
442005
India 
Phone  7749994991  
Fax    
Email  prerna258@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kamlesh Chaudhari 
Designation  Professor 
Affiliation  Jawaharlal Nehru Medical College , DMIHER  
Address  Room no 11,IVF LAB , AVBR Hospital
JNMC , sawangi ( meghe ), Wardha, Maharashtra
Wardha
MAHARASHTRA
442005
India 
Phone  7749994991  
Fax    
Email  dr.kamleshchaudhari@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prerna 
Designation  IVF fellow 
Affiliation  Jawaharlal Nehru Medical College , DMIHER  
Address  Room no 11, IVF LAB , AVBR Hospital
JNMC , sawangi ( meghe ), Wardha, Maharashtra
Wardha
MAHARASHTRA
442005
India 
Phone  7749994991  
Fax    
Email  prerna258@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Medical College, Sawangi ,WArdha, Maharashtra, India-442005 
 
Primary Sponsor  
Name  JNMC, Sawangi 
Address  DMIHER, Sawangi , Wardha-442005 
Type of Sponsor  Private medical college 
 
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 Prerna  Jawaharlal Nehru Medical College   room no 11, Wardha test tube centre , JNMC , SAWANGI (MEGHE)-442005
Wardha
MAHARASHTRA 		 7749994991

prerna258@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe, DMIHER   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E35||Disorders of endocrine glands in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Women with previous 1 or more failed IVF treatment.
Women who will sign informed consent after completely comprehending the contents of the study.
Women with basic ability to read, communicate and complete the questionnaire independently.
 
 
ExclusionCriteria 
Details  Women with previous or current mental disorders, cognitive impairments or inability to understand.
Women with severe chronic diseases.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment of quality of life in patients with previous failed IVF treatment using WHO Ferti-QoL Questionairre  At the time of first visit  
 
Secondary Outcome  
Outcome  TimePoints 
NOT AVAILABLE  NIL 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   30/04/2024 
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)   Open to Recruitment 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 01-12-2023 and end date provided 31-05-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

With changes in the living environment, the accelerating pace of life and delays in marriage and childbearing, the incidence of infertility is rising year by year. According to statistics from the World Health Organization (WHO), approximately 8–12%  of couples world- wide have experienced infertility. Since the approaches of controlled ovarian stimulation (COS) and the conditions of the embryonic laboratory have improved, In vitro fertilization-embryo transfer (IVF-ET), as the main assisted reproductive therapy for infertile patients, brings hope to many infertile patients. However, despite high-quality embryos, many patients remain whose embryos cannot be implanted normally for various reasons.The QoL of women with infertility is obviously lower than that of other women of childbearing age. The decrease in patients’ QoL affects patient treatment compliance, thereby affecting the pregnancy rate .

 

RESEARCH QUESTION

To determine influencing factors affecting Fertility quality of life in Infertile women with previous failed IVF treatment  

•        Population-  Infertile women with previous failed IVF treatment in rural tertiary care hospital.

•        Intervention- No intervention

•        Comparision- No comparision

•        Outcomes- Analysing outcomes affecting FertiQoL

 
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