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CTRI Number  CTRI/2025/12/099950 [Registered on: 29/12/2025] Trial Registered Prospectively
Last Modified On: 23/12/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Role of artificial intelligence in decision-making and improving pregnancy outcomes in patients going for In-Vitro Fertilisation(IVF) cycle 
Scientific Title of Study   Augmented intelligent clinical support systems to aid decision-making for pregnancy outcomes after In-Vitro Fertilisation or Intracytoplasmic sperm injection 
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. Neena Malhotra 
Designation  Professor and Head of Department of Obstetrics and Gynaecology 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room No 701, 7th Floor, Mother and Child Block, All India Institute of Medical Sciences, Ansari Nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  9891557707  
Fax    
Email  malhotraneena@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Neena Malhotra 
Designation  Professor and Head of Department of Obstetrics and Gynaecology 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room No 701, 7th Floor, Mother and Child Block, All India Institute of Medical Sciences, Ansari Nagar, New Delhi


DELHI
110029
India 
Phone  9891557707  
Fax    
Email  malhotraneena@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Neena Malhotra 
Designation  Professor and Head of Department of Obstetrics and Gynaecology 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room No 701, 7th Floor, Mother and Child Block, All India Institute of Medical Sciences, Ansari Nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  9891557707  
Fax    
Email  malhotraneena@yahoo.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, AIIMS Campus, Ansari Nagar East, New Delhi, 110029 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  AIIMS campus temple,Ansari Nagar East, New Delhi, 110029 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Neena Malhotra  All India Institute of Medical Sciences, New Delhi  Room No 701, 7th floor, Mother and Child block, All India Institute of Medical sciences, Ansari Nagar East, New Delhi, 110029
New Delhi
DELHI 
9891557707

malhotraneena@gmail.com 
Dr Mohan Shashikant Kamath  Christian Medical College, Vellore  Department of Reproductive medicine and Surgery, Christian medical college, IDA Scudder Road, Vellore, 632004
Vellore
TAMIL NADU 
9994497690

mohankamath@cmcvellore.ac.in 
Dr Rintu Kutum  Koita Centre for Digital Health - Ashoka University  Department of computer science, Trivedi school of biosciences, Ashoka University, GT Karnal road, Block D, Rajasthan Udyog nagar, Jahangirpuri
North East
DELHI 
7838369344

rintu.kutum@ashoka.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institute Ethics Committee, All India Institute of Medical Sciences, New Delhi  Approved 
INSTITUTIONAL REVIEW BOARD (IRB) OFFICE OF RESEARCH CHRISTIAN MEDICAL COLLEGE VELLORE, INDIA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N979||Female infertility, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. All women who underwent IVF cycle in past 12 years and within subsequent 2 years after approval of the project
2. Complete follow up available till live birth or until the last complete cycle.
 
 
ExclusionCriteria 
Details  1. Patients with incomplete data records 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Development of interoperable common data model   12 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Number of visits per patient
2. Time duration from decision of IVF to initiation of ovarian stimulation  
Baseline, 6 months, 12 months 
 
Target Sample Size   Total Sample Size="8000"
Sample Size from India="8000" 
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)   01/02/2026 
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="2"
Months="0"
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  

One of the biggest challenges of managing a fertility clinic is handling large amounts of data. Managing In-Vitro Fertilisation (IVF) treatments by using augmented intelligent systems makes it easy to enter and organize data about the patients, their treatments, the tests performed, equipment used, manage appointments & schedules as well as audit the  IVF results for quality assurance purposes. There is a felt need for a uniform digitalization system to allow to consolidation of information from various sources present in an IVF clinic such as labs, operating rooms, ultrasound rooms, consulting rooms, and registration desks which are both accessible and highly secure.

.In the last decade, the demand for Assisted Reproductive Technologies(ART) has significantly increased with India contributing to one of the highest growths in the number of ART centres and number of cycles per year (1). Despite having planned a national ART registry after the latest ART Act 2021, there is a lack of uniform data reporting system across all centres in India. There is no clinical prediction model available from India to predict success rates after IVF. Considering several individual patient variables and characteristics of treatment received in the past that may affect IVF outcomes, it is difficult and inappropriate to do generalised counselling regarding success rates after a complete IVF cycle. Thus, it becomes critical to individualise the counselling of each couple which further needs to be revised after one or more cycles for improved counselling and decision making.

Therefore, this study proposes to develop an augmented intelligent system suited to meet patient daily requirements and keep patient data organised to deliver the best quality care as well as create a unform clinical registry. 

 
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