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CTRI Number  CTRI/2022/06/043228 [Registered on: 13/06/2022] Trial Registered Prospectively
Last Modified On: 26/10/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Quality of life in infertile individual / couple  
Scientific Title of Study   Quality of life in infertile individual / couple with poor ovarian reserve requiring donor oocytes and its related factors attending infertility clinic- A multi-centric cross-sectional study  
Trial Acronym  QOL-POR 
Secondary IDs if Any  
Secondary ID  Identifier 
IIHPL-UDR/P/004_2021 Version 1.0 dated 10-January -2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nihar Ranjan Bhoi 
Designation  Head Clinical and Audit 
Affiliation  Indira IVF Hospital 
Address  44 Kumharon ka Bhatta Indira IVF Hospital Private Limited Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  7205783512  
Fax    
Email  drnihar.bhoi@indiraivf.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Nihar Ranjan Bhoi 
Designation  Head Clinical and Audit 
Affiliation  Indira IVF Hospital 
Address  44 Kumharon ka Bhatta Indira IVF Hospital Private Limited Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  7205783512  
Fax    
Email  drnihar.bhoi@indiraivf.in  
 
Details of Contact Person
Public Query  
Name  Dr Nihar Ranjan Bhoi 
Designation  Head Clinical and Audit 
Affiliation  Indira IVF Hospital 
Address  44 Kumharon ka Bhatta Indira IVF Hospital Private Limited Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  7205783512  
Fax    
Email  drnihar.bhoi@indiraivf.in  
 
Source of Monetary or Material Support  
Indira IVF Hospital Pvt Ltd Udaipur 
 
Primary Sponsor  
Name  Indira IVF Hospital Private Limited  
Address  44, Amar Niwas, kumbharon ka Bhatta, Udaipur 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NONE  NONE 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sindhu Gupta  Indira IVF hospital Bangalore  2nd Floor Boomi Plaza, Binnamangala Hoysalanagar, Chinmaya Mission Hospital Rd, Near Metro Station, Stage 1, Indiranagar, Bengaluru, Karnataka 560038
Bangalore
KARNATAKA 		 9986530015

sindhu.gupta@indiraivf.in 
Dr Sasmita Naik  Indira IVF hospital Bhubneshwar  Triplex, 2nd Floor, Gajapatinagar, Sachivalaya Marg, Chandrasekharpur, Bhubaneswar, Odisha 751013
Khordha
ORISSA 		 8596977293

centerhead.bhubaneswar@indiraivf.in 
Dr Prachi Tondon  Indira IVF hospital Borivali  Shop no. 2,3, Ambrosia Building, Western Express Hwy, Devipada, Borivali East, Mumbai, Maharashtra 400066
Mumbai
MAHARASHTRA 		 8850904573

drprachitandon.borivali@indiraivf.in 
Dr Hritul Madge  Indira IVF hospital Delhi  Metro Station, 9,Opposite Metro Pillar 203, Near Patel Nagar, Old Ranjit Nagar Rd, South Patel Nagar, New Delhi, Delhi 110008
Pune
MAHARASHTRA 		 7002113877

drhritul.pune@indiraivf.in 
Dr Navina Singh  Indira IVF hospital Hyderabad  SHOP NO - 8, Athena 2nd floor plot no 8, Road No. 12, near Century Hospital, Banjara Hills, Hyderabad, Telangana 500034
Hyderabad
TELANGANA 		 8879790169

centerhead.hyderabad@indiraivf.in 
Dr Akansha Jangid  Indira IVF hospital Kolkata  Pataka House, 3rd, 57-B, Mirza Ghalib St, Park Street area, Kolkata, West Bengal 700016
Kolkata
WEST BENGAL 		 9781541418

centerhead.kolkata@indiraivf.in 
Dr Pawan Yadav  Indira IVF hospital Lucknow  1, Tilak Marg, opp. National PG College Play Ground, Hazratganj, Lucknow, Uttar Pradesh 226001
Lucknow
UTTAR PRADESH 		 9521538238

centerhead.lucknow@indiraivf.in 
Dr Dayanidhi Sharma  Indira IVF hospital Patna  4th Floor, Kashyap Complex, Above Big Bazar, Bailey Road, Patna 800014 Bihar India
Patna
BIHAR 		 9011803606

centerhead.patna@indiraivf.in 
Dr Anjali Sharma  Indira IVF Hospital Prayagraj  41/2, Mohalla Civil Station, Lal Bahadur Shastri Marg, near Hanuman Mandir, Civil Lines, Prayagraj, Uttar Pradesh 211001
Allahabad
UTTAR PRADESH 		 9793116314

centerhead.allahabad@indiraivf.in 
Dr Saumya Somani  Indira IVF hospital Udaipur  44, Amar Niwas, kumbharon ka Bhatta, Udaipur
Udaipur
RAJASTHAN 		 9928314631

drsaumya.somani@indiraivf.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Indira IVF Hospital Institutional Ethics Committee Mumbai  Approved 
Indira IVF Hospital Institutional Ethics Committee (Bangalore)  Approved 
Indira IVF Hospital Institutional Ethics Committee (Delhi)  Approved 
Indira IVF Hospital Institutional Ethics Committee (Hyderabad)  Approved 
Indira IVF Hospital Institutional Ethics Committee (Kolkata)  Approved 
Indira IVF Hospital Institutional Ethics Committee (Lucknow)  Approved 
Indira IVF Hospital Institutional Ethics Committee (Patna)  Approved 
Indira IVF Hospital Institutional Ethics Committee (Prayagraj)  Approved 
Indira IVF Hospital Institutional Ethics Committee (Udaipur)  Approved 
Indira IVF Hospital Institutional Ethics Committee(Bhubaneswar)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O090||Supervision of pregnancy with history of infertility,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NONE  NONE 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. All the infertile individuals or couple attending in-vitro fertilization centers and giving consent
2. Women with poor ovarian reserve AFC<5, AMH< 0.5ngm/dl.
3. Patients between 25-45 years of age
 
 
ExclusionCriteria 
Details  1.More than 45 years of age
2. Terminal stage of illness such as cancer, HIV-AIDS, transplant patients, etc.
3. COVID-19 disease
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Quality of life among the infertile individual / couple  At the time of the interview during first week 
 
Secondary Outcome  
Outcome  TimePoints 
Factors influencing the poor quality of life among infertile individual / couple.  At the time of interview in first week of visit 
 
Target Sample Size   Total Sample Size="210"
Sample Size from India="210" 
Final Enrollment numbers achieved (Total)= "968"
Final Enrollment numbers achieved (India)="968" 
Phase of Trial   N/A 
Date of First Enrollment (India)   13/06/2022 
Date of Study Completion (India) 21/08/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 21/08/2023 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
 According to a substantial body of literature, infertility negatively affects QoL and appears to lead to mental problems, such as anxiety, depression, frustration, isolation, disturbed identity, and lack of attraction [4,5]. A few studies have investigated QoL in infertile individual / couple with non-specific questionnaires, such as the World Health Organization Quality of Life form (WHOQOLBREF) and Health Survey Short Form (SF-36). A few studies used the Fertility QoL (FertiQol) questionnaire as a fertility-specific QoL assessment of infertile individuals.
  Objectives- Â·            To determine the quality of life among the infertile individual / couple attending Indira IVF centers at designated sites as mentioned.
                     Â·            To find out the association of poor quality of life with different socio-demographic, medical, and personal characteristics of infertile individual / couple.

  Rationale             Until now, few studies have investigated factors that impact QoL in infertile individual / couple. Of particular importance is how the factors that predict QoL vary               couplesin different infertile populations. Recognition of these associated factors is essential for program planning to increase the QoL of the infertile population.

  Study Outcome             Quality of life among the infertile individual / couple

                                   Factors influencing the poor quality of life among infertile individual / couple

Hypothesis             We hypothesize that the quality of life among infertile individual / couple will be low.

STUDY DESIGN

  Description of the Study Design- A multicentric facility-based cross-sectional study.

 Study Tool- A semi-structured, pretested questionnaire will be used for data collection. The necessary modification will be incorporated into the questionnaire after pretesting. 

  Data collection:

Data collectors will be identified and trained at each selected center for data capture. Written informed consent will be taken explaining the purpose of the study before administering the questionnaire. The questionnaire’s digital format will be developed in both languages using the Microsoft forms platform for easy capture and clean data collection. Study Population

All the infertile couples attending in-vitro fertilization centers for their treatment will be our study population.

Study Sites

For 10 study site

   Duration of study

Jan 2022 to June 2022(6 months)


 
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