| CTRI Number |
CTRI/2026/02/104011 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Oxidative Stress: The Hidden Factor Affecting Sperm Health. |
|
Scientific Title of Study
|
Spectrophotometry quantification of Reactive
Oxidative species in Seminal Plasma and its correlation with sperm vitality |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sibi S |
| Designation |
Postgraduate |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Department of Clinical Embryology
EVR Periyar street Thirumalapuram Bodinayakanur Theni DT.
Theni
TAMIL NADU
625531
India |
| Phone |
6380271720 |
| Fax |
|
| Email |
Kit.24.20bbt044@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrNidhi Sharma S |
| Designation |
Proffesor |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Department of Clinical Embryology
Saveetha Institute of Medical and Technical Sciences
No 162,Poonamalle High Road,Chennai-600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9445560392 |
| Fax |
91-44-26800892 |
| Email |
nidhisharma.smc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
DrNidhi Sharma S |
| Designation |
Proffesor |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Department of Clinical Embryology
Saveetha Institute of Medical and Technical Sciences
No 162,Poonamalle High Road,Chennai-600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9445560392 |
| Fax |
91-44-26800892 |
| Email |
nidhisharma.smc@saveetha.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Saveetha Institute of Medical and Technical Sciences
Saveetha Nagar,Thandalam,Chennai-602105. |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrNidhi Sharma S |
Saveetha Institute of Medical and Technical Sciences |
Department of Clinical Embryology
Saveetha Nagar,Thandalam,Chennai-602105.
Chennai
TAMIL NADU |
9445560392
91-44-26800892
nidhisharma.smc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Scientific Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N469||Male infertility, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1. Male participants aged 21-45 years
2. Those providing informed consent for seamen analysis
3. No history of chronic illnesses affecting fertility |
|
| ExclusionCriteria |
| Details |
1. Recent fever or infection within 3 months.
2. History of varicocele, cryptorchidism, or reproductive tract surgery
3. Use of antioxidant supplements or fertility treatments during the last 3 months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quantitative estimation of reactive oxygen species (ROS) levels in seminal plasma using spectrophotometric method. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
22/02/2026 |
| 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="1"
Months="0"
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
|
This study aims to evaluate the levels of Reactive Oxygen Species (ROS) in seminal plasma using quantitative spectrophotometric analysis. The research will investigate how high ROS levels impact sperm membrane integrity and sperm vitality in men undergoing fertility evaluation. Furthermore, the study will correlate these oxidative stress markers with the clinical pregnancy outcomes of Intrauterine Insemination (IUI) procedures. Semen samples will be analyzed at baseline during the IUI process, and follow-up for clinical pregnancy will be conducted 4 to 6 weeks after the procedure to determine the predictive value of ROS in successful conception. |