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CTRI Number  CTRI/2025/03/082036 [Registered on: 10/03/2025] Trial Registered Prospectively
Last Modified On: 05/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Other 
Public Title of Study   Sperm DNA Fragmentation Assessment by using artificial intelligence and comparison with other standard methods  
Scientific Title of Study   Comparing Artificial intelligence enhanced Sperm DNA Fragmentation Assessment to Traditional methods  
Trial Acronym  NIL  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrM Geethanjali  
Designation  Postgraduate in Obstetrics and Gynaecology  
Affiliation  Saveetha Medical College and Hospital  
Address  Saveetha Medical College and Hospital,Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105

Chennai
TAMIL NADU
602105
India 
Phone    
Fax    
Email  drgeethanjalishyam@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nidhi Sharma  
Designation  Professor of Obstetrics and Gynaecology  
Affiliation  Saveetha Medical College and Hospital  
Address  Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105

Chennai
TAMIL NADU
602105
India 
Phone  9445560392  
Fax    
Email  nidhisharma.smc@saveetha.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nidhi Sharma  
Designation  Professor of Obstetrics and Gynaecology  
Affiliation  Saveetha Medical College and Hospital  
Address  Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105


TAMIL NADU
602105
India 
Phone  9445560392  
Fax    
Email  nidhisharma.smc@saveetha.com  
 
Source of Monetary or Material Support  
Saveetha Medical College and Hospitals, Thandalam,chennai 602105  
 
Primary Sponsor  
Name  Dr M Geethanjali  
Address  Saveetha Medical College and Hospital,Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105 
Type of Sponsor  Other [(self)] 
 
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 Geethanjali   Saveetha Medical College and Hospitals  Department of Obstetrics and Gynaecology, 1st floor Thandalam,
Chennai
TAMIL NADU 
8754329221

drgeethanjalishyam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Medical College and Hospital - Institutional Ethical Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: N528||Other male erectile dysfunction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Application on sperm DNA fragmentation assessment   Comparative agent: standard methods of sperm DNA fragmentation assessment  
Intervention  Application on Sperm DNA fragmentation assessment  The intervention involves implementing an artificial intelligence-based system to analyze sperm DNA fragmentation. This includes training machine learning algorithms on sperm DNA images or data obtained from assays (e.g., TUNEL, SCSA). The AI system automates fragmentation detection, identifies abnormalities, and generates results, replacing or augmenting traditional manual or semi-automated methods. COMPARATOR AGENT WITH STANDARD METHODS OF SPERM DNA FRAGMENTATION  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  Age from 25-45 years,married for more than 1 year with unprotected Sexual intersource,with no structural abnormalities in male genital system. 
 
ExclusionCriteria 
Details  Male more than 45 years  
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Results from the study indicate that the AI-enhanced method significantly improves the accuracy and reliability of sperm DNA fragmentation assessments.
This thesis contributes to the growing field of reproductive medicine by demonstrating the potential of AI technologies to transform traditional diagnostic processes, ultimately aiming to improve fertility treatments and outcomes for couples facing infertility challenges.
 
Outcome will be assessed within minutes  
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Outcomes:

1. Time efficiency in processing and analysis.


2. Cost-effectiveness of AI vs. standard methods.


3. Reproducibility and consistency of results.


4. Impact on fertility treatment success rates.


5. User-friendliness and scalability of AI-based systems.



 
 
Secondary outcomes of a sperm DNA fragmentation test include fertilization success, embryo quality, pregnancy & miscarriage rates, live birth outcomes, & response to treatments like antioxidants. It also assesses correlations with sperm motility, morphology, & lifestyle factors affecting fertility, providing insights into reproductive potential & assisted reproduction success.

 
8 weeks  
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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   Phase 2 
Date of First Enrollment (India)   26/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  26/03/2025 
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 - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drgeethanjalishyam@gmail.com].

  6. For how long will this data be available start date provided 20-12-2024 and end date provided 20-03-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   A study on the application of sperm DNA fragmentation (SDF) assessment, comparing artificial intelligence (AI) with standard methods, could include the following:

Title

Application of Artificial Intelligence in Sperm DNA Fragmentation Assessment: A Comparative Study with Standard Methods
Abstract

This study evaluates the effectiveness of AI-driven techniques in assessing sperm DNA fragmentation (SDF) compared to conventional methods such as the sperm chromatin dispersion (SCD) test, terminal deoxynucleotidyl transferase-mediated dUTP nick-end labeling (TUNEL) assay, and the COMET assay. The goal is to explore AI’s accuracy, speed, reproducibility, and potential as a cost-effective alternative in reproductive medicine.
Introduction

SDF as a Key Biomarker:
Sperm DNA fragmentation is a critical biomarker in male infertility, associated with poor assisted reproductive outcomes.

Traditional Methods:
TUNEL assay, SCD test, and COMET assay are the most commonly employed techniques but are time-intensive, costly, and prone to inter-observer variability.

AI in Reproductive Medicine:
AI is emerging as a transformative tool due to its ability to automate processes, analyze images, and reduce human error.

Objectives

1. Compare the accuracy of AI-based SDF assessment tools with standard techniques.

2. Evaluate the efficiency (time and cost) and reproducibility of AI in clinical settings.

3. Investigate the potential for AI to reduce inter-laboratory variability in SDF assessment.

Materials and Methods

Study Design:

A comparative, cross-sectional study involving a cohort of 200 sperm samples from infertile and fertile men.

Assessment Techniques:

1. Standard Methods:

TUNEL Assay: Measures DNA fragmentation by labeling DNA breaks.

SCD Test: Detects DNA fragmentation via halo formation after acid denaturation.

COMET Assay: Evaluates DNA damage through single-cell gel electrophoresis.

2. AI-Based Analysis:

Image-based algorithms trained on SDF data.

Deep learning models optimized to detect and quantify DNA fragmentation in sperm cells.


Parameters Evaluated:

Sensitivity, specificity, and accuracy.

Time to process and analyze samples.

Cost comparison.

Reproducibility across technicians and laboratories.


Statistical Analysis:

Use Receiver Operating Characteristic (ROC) curves to compare methods, and conduct inter-rater reliability tests for reproducibility.

Results

Expected outcomes include:
AI showing higher or equivalent sensitivity and specificity compared to TUNEL and SCD tests.

Significant reduction in processing time and cost with AI-based methods.

Higher reproducibility in AI assessments due to minimized human error.

Discussion: Strengths of AI: Its scalability, cost-effectiveness, and capacity to standardize SDF assessments.

Challenges: The need for robust training datasets and validation in diverse populations.

Future Directions: Integration of AI tools in clinical workflows for infertility diagnostics.

Conclusion: The use of AI in sperm DNA fragmentation assessment demonstrates significant promise as a faster, more reliable, and cost-effective alternative to conventional methods, paving the way for improved diagnostic capabilities in male infertility management.



 
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