| 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
|
|
|
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
|
|
|
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. |