| 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 |
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Type of Study
|
Diagnostic |
| Study Design |
Other |
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Public Title of Study
|
Sperm DNA Fragmentation Assessment by using artificial intelligence and comparison with other standard methods |
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Scientific Title of Study
|
Comparing Artificial intelligence enhanced Sperm DNA Fragmentation Assessment to Traditional methods |
| Trial Acronym |
NIL |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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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 |
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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 |
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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 |
|
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Source of Monetary or Material Support
|
| Saveetha Medical College and Hospitals, Thandalam,chennai 602105 |
|
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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)] |
|
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital - Institutional Ethical Committee |
Approved |
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Regulatory Clearance Status from DCGI
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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, |
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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 |
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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 |
|
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Method of Generating Random Sequence
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Adaptive randomization, such as minimization |
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Method of Concealment
|
An Open list of random numbers |
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Blinding/Masking
|
Open Label |
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Primary Outcome
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| 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.
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Outcome will be assessed within minutes |
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Secondary Outcome
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| 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.
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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 |
|
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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" |
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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 |
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Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drgeethanjalishyam@gmail.com].
- 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.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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Brief Summary
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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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