FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/09/095285 [Registered on: 23/09/2025] Trial Registered Prospectively
Last Modified On: 22/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Relationship of age and selected life style factors with DFI of Indian infertile men attending fertility clinics: A retrospective study 
Scientific Title of Study   Effect of age and selected life style factors with DNA Fragmentation index of Indian infertile men attending fertility clinics: A retrospective study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  sancho rajan 
Designation  Fellowship student 
Affiliation   
Address  GarbhaGudi IVF Centre, Subhasri Complex, 210/A, Kumaraswamy Temple Rd, 2nd Block, Phase 1, Banashankari 1st Stage, Bengaluru, Karnataka 560050

Bangalore
KARNATAKA
560050
India 
Phone  08056941711  
Fax    
Email  sanchorajan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Fzullah Syed 
Designation  Mr 
Affiliation  Director of Embryology  
Address  GarbhaGudi IVF Centre, Subhasri Complex, 210/A, Kumaraswamy Temple Rd, 2nd Block, Phase 1, Banashankari 1st Stage, Bengaluru, Karnataka 560050

Bangalore
KARNATAKA
560050
India 
Phone    
Fax    
Email  labdirector@garbhagudi.com   
 
Details of Contact Person
Public Query
 
Name  sancho rajan 
Designation  Fellowship student 
Affiliation  Garbhagudi IVF centre 
Address  GarbhaGudi IVF Centre, Subhasri Complex, 210/A, Kumaraswamy Temple Rd, 2nd Block, Phase 1, Banashankari 1st Stage, Bengaluru, Karnataka 560050

Bangalore
KARNATAKA
560050
India 
Phone  08056941711  
Fax    
Email  sanchorajan@gmail.com  
 
Source of Monetary or Material Support  
GarbhaGudi IVF Centre, Subhasri Complex, 210/A, Kumaraswamy Temple Rd, 2nd Block, Phase 1, Banashankari 1st Stage, Bengaluru, Karnataka  
 
Primary Sponsor  
Name  Sancho Rajan 
Address  GarbhaGudi IVF Centre, Subhasri Complex, 210A, Kumaraswamy Temple Rd, 2nd Block, Phase 1, Banashankari 1st Stage, Bengaluru, Karnataka 560050 
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 SR Raajam Murali  GARBHAGUDI IVF CENTRE  Senior Fertility Specialist, GarbhaGudi IVF Centre Bengaluru, Karnataka 560050
Bangalore
KARNATAKA 
9108910832

drraajam@garbhagudi.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
GarbhaGudi Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Retrospective collection of male participants data 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  23.00 Year(s)
Age To  55.00 Year(s)
Gender  Male 
Details  Male patients aged between 23 to 55 years
BMI greater than Normal 18.4 to 24.9 kg/m2, overweight between 25 to 29 kg/m2, Obese greater than 30 kg/m2
Underwent Sperm chromatin dispersion assay testing for DFI
• Patients who are experiencing infertility for more than 1 year of unprotected intercourse without conception
 
 
ExclusionCriteria 
Details  Retrograde ejaculation, severe oligospermia less than 1 mil/ml, azoospermia
Cryopreserved sperm
Sperm retrieved from surgery
Patients with incomplete medical records and incomplete seminal parameters will be excluded from the retrospective study.
Patients with history of genetic disorders affecting infertility.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Patients having the history of smoking, and alcoholism, tobacco chewing as any relationship with DFI

 
4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Occupation hazard as any relationship with DFI  4 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   05/10/2025 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

 

In this retrospective study approach, data on sub-fertile men visiting the Garbhagudi Institute of Reproductive Health & Research was collected using World Health Organization 2010 criteria. The primary objective of this study is to analyze the relationship of age and lifestyle on DFI of infertile men attending infertility clinic. The secondary objective is to assess the impact of semen parameters and sperm morphology on DFI. To determine whether round head sperms are more common in DFI high level patients’ semen samples.  In this retrospective approach from the IVF center, data of patients are collected based on their chronological age, selected lifestyle characteristics such as alcoholism, smoking, tobacco chewing, BMI and occupational hazard infertile males screened for sperm DFI, and infertility duration of more than two years. Exclusion criteria include patients with retrograde ejaculation, severe oligospermia (under 1 mil/ml), azoospermia, cryopreserved sperm, and surgically extracted sperm. Patients who have incomplete medical records and a history of infertility-related genetic diseases. This study seeks to improve our understanding of how modifiable and non-modifiable factors contribute to sperm DNA damage, potentially aiding in better risk stratification and treatment planning for infertile couples. The findings may also have implications for pre-treatment counselling and lifestyle interventions.

 
Close