| CTRI Number |
CTRI/2026/02/103414 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparing Swim-Up and Density Gradient Methods for Sperm Preparation Effects on Quality and Oxidative Stress
|
|
Scientific Title of Study
|
Advanced Comparative Analysis of Swim-Up and Density Gradient Sperm Preparation Methods Correlation of MorphologyMotility Vitalityand Oxidative Stress Markers (ROS) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manisha S |
| Designation |
Post graduate |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Department of clinical embryology
25/B 2nd Sengunthar cross street kaspa A Ambur
Tirupathur 635802
Department of clinical embryology
M/S kumaravalli
C/0 Mani R A/2 5th cross 2nd street c sector VG Rao Nagar
Katpadi vellore 632007
Vellore
TAMIL NADU
635802
India |
| Phone |
9361253669 |
| Fax |
|
| Email |
manishasathish649@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nidhi sharma s |
| Designation |
Professor |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Department of clinical Embryology 162 Poonamallee High Road Chennai 600 077
Department of clinical Embryology 162 Poonamallee High Road Chennai 600 077
Chennai
TAMIL NADU
600077
India |
| Phone |
9445560392 |
| Fax |
914426800892 |
| Email |
nidhisharma.smc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhi sharma s |
| Designation |
Professor |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Department of clinical Embryology 162 Poonamallee High Road Chennai 600 077
Department of clinical Embryology 162 Poonamallee High Road Chennai 600 077
Chennai
TAMIL NADU
600077
India |
| Phone |
9445560392 |
| Fax |
914426800892 |
| Email |
nidhisharma.smc@saveetha.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Saveetha Nagar, Thandalam, Chennai – 602105, Tamil Nadu, India |
| 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 |
| Dr Nidhi sharma s |
Saveetha Institute of Medical and Technical Sciences |
Department of clinical embryology
Saveetha Nagar, Thandalam, Chennai – 602105, Tamil Nadu, India
Chennai
TAMIL NADU |
9445560392
914426800892
nidhisharma.smc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Scientific Review Board Saveetha Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z923||Personal history of irradiation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Age 21-45yrs
BMI 18-30Kg/m²
Married for less than 1 years
Patients with Normozoospermia sample under going IVF/ICSI
No genitial infection
No recent medication |
|
| ExclusionCriteria |
| Details |
Donor recipient cycle
Leucocytospermia
Azoospermia
Severe OATS
Recent infection of Fever
Patients with Wash technique for IVF/ICSI
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical relevance
Measurable
Comparative focus |
Half an hour incubation |
|
|
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)
|
18/02/2026 |
| 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 comparatively evaluate two commonly used sperm preparation techniques—Swim-up and Density Gradient (DG) methods. The analysis focuses on assessing and correlating key sperm functional parameters including motility, morphology, vitality, and reactive oxygen species (ROS) levels. By comparing the efficiency of these two methods, the study seeks to identify which technique yields sperm with better functional quality and lower oxidative stress, thereby supporting improved outcomes in assisted reproductive techniques (ART). |