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CTRI Number  CTRI/2025/02/080360 [Registered on: 12/02/2025] Trial Registered Prospectively
Last Modified On: 11/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Other 
Public Title of Study   Development of a 3D printed Microfluidic Sperm Sorting Chamber For Enhanced Reproductive Success 
Scientific Title of Study   The Assessment of sperm viability and motility using 3D printed microfluidic sorting chambers-A randomized control trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kalpana L 
Designation  Postgraduate student 
Affiliation  Saveetha medical college and hospital 
Address  Room no 150 OPD Saveetha medical college and hospital Department of Obstetrics and Gynaecology Poonamalle high road Kuthambakkam Chennai 602105

Kancheepuram
TAMIL NADU
602105
India 
Phone  08940249797  
Fax    
Email  kalpanaloganathan27@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nidhi sharma 
Designation  PROFESSOR 
Affiliation  saveetha medical college and hospital 
Address  ROOM NO 150 SAVEETHA MEDICAL COLLEGE AND HOSPITAL DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY KUTHAMBAKKAM THANDALAM CHENNAI

Kancheepuram
TAMIL NADU
602105
India 
Phone  9445560392  
Fax    
Email  nidhisharma.smc@saveetha.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kalpana L 
Designation  postgraduate 
Affiliation  Saveetha medical college and hospital 
Address  Room No 150 OPD DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY SAVEETHA MEDICAL COLLEGE AND HOSPITAL THANDALAM CHENNAI

Kancheepuram
TAMIL NADU
602105
India 
Phone  08940249797  
Fax    
Email  kalpanaloganathan27@gmail.com  
 
Source of Monetary or Material Support  
saveetha medical college and hospital,Saveetha nagar,Thandalm,Chennai-602105, Tmilnadu,India 
 
Primary Sponsor  
Name  Dr kalpana L 
Address  Saveetha medical college and hospital thandalam, Chennai-602105, Tamilnadu,India. chennai 
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 
DrKalpana L  Saveetha medical college and hospital  Department of Obstetrics and Gynaecology,Saveetha medical college and hospital thandalam chennai
Kancheepuram
TAMIL NADU 
8940249797

kalpanaloganathan27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha medical college and hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  density gradient method  Standard sperm sorting methods (e.g., density gradient centrifugation or swim-up technique) Dosage/Duration/Procedure: • Sorting is performed once per sample, with the procedure taking approximately 30 to 60 minutes per run. • A single session is conducted for each participant or sample. Follow-up Schedule: • Immediate assessment after sorting • Follow-up evaluation of sperm functionality at 24 hours post-sorting Mode of Delivery: In-laboratory sperm sorting using the microfluidic device Purpose: To assess the effectiveness, purity, and viability of sperm isolated using the microfluidic sperm sorting chamber for potential use in ART. 
Intervention  micro fluidic sperm sorting chamber  The microfluidic sperm sorting chamber is a non-invasive device designed to isolate high-quality sperm based on motility, morphology, and viability. The chamber uses fluid dynamics to selectively sort motile and morphologically normal sperm while minimizing contamination from non-target cells and preserving sperm DNA integrity. This device offers an alternative to conventional centrifugation-based sperm preparation methods, aiming to improve outcomes for assisted reproductive technologies (ART). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  Men undergoing infertility tteatment
men who have normal sperm morphology and motility 
 
ExclusionCriteria 
Details  Sperm count less than 1million/ml
• HIV
• HBsAg
• Syphilis 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Percentage of motile, morphologically normal sperm cells successfully isolated using the microfluidic sperm sorting chamber.

 
Percentage of motile, morphologically normal sperm cells successfully isolated using the microfluidic sperm sorting chamber at 24 to 48hours after using the sorted sperm for icsi/ivf/fertilization test

 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of Target vs. Non-Target Cells:
Outcome: Measure of purity, indicating the ratio of target sperm cells to non-target cells.
total Number of Viable Sorted Sperm Cells Recovered:Outcome: Yield of viable sperm cells retained after sorting.
Percentage of Sorted Sperm Cells Remaining Viable:Outcome: Assessment of cell viability post-sortingreservation of Sperm Functionality (Motility, Morphology, and DNA Integrity):Outcome: Evaluation of functional parameters critical for fertilization potential.onsistency and Reliability of Sorting Outcomes Across Multiple Runs:Outcome: Reproducibility of results across multiple independent experiments.

 
immediately post-sorting.
Immediately post-sorting.
Immediately and 24 hours post-sorting.
Immediately and 24 hours post-sorting.
Evaluated across at least three separate experiments. 
 
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)   22/02/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 paper introduces the development of a microfluidic sperm sorting chamber, harnessing the capabilities of 3D printing technology. The amalgamation of microfluidics and 3D printing presents a novel approach to designing and manufacturing microscale devices tailored for sperm sorting applications. By exploiting the versatility of 3D printing, we aim to address existing limitations in conventional microfluidic fabrication methods, such as time-consuming and costly processes, limited design flexibility, and challenges in scaling production.

The primary objective of this endeavor is to engineer a microfluidic chamber capable of precisely isolating sperm cells based on desired parameters, such as motility, morphology, or DNA integrity. Leveraging the principles of microfluidics, the chamber will facilitate controlled seminal plasma and seprm  flow and precise manipulation of sperm cells, ensuring high efficiency and accuracy in sorting. Furthermore, the integration of 3D printing technology enables the customization of chamber geometries(surface like increasing area,round edges ,membrane passage etc) and features to accommodate diverse experimental requirements and enhance performance.

In addition to technological advancements, this research endeavors to address critical considerations regarding biocompatibility, cell viability, and reproducibility. Ensuring that the materials used in 3D printing and the microfluidic chamber maintain the viability and functionality of sperm cells is essential for the translational potential of this technology in clinical and research settings.

Through sperm survival test, we aim to demonstrate the efficacy, reliability, and scalability ,safety of the developed microfluidic sperm sorting chamber. Furthermore, exploring potential clinical applications, such as in ART procedures, animal breeding programs, and reproductive health research, will underscore the broader significance and impact of this technology in animal IVF and saving endangered species of planet.
In collaboration with experts in microfluidics, reproductive biology, and 3D printing technology, this interdisciplinary effort seeks to push the boundaries of innovation in the field of sperm sorting. By fostering knowledge exchange and leveraging diverse expertise, we strive to accelerate the development and dissemination of this transformative technology, ultimately empowering researchers and clinicians to advance reproductive science and improve patient outcomes.
 
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