| 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
|
|
|
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
|
|
|
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. |