| 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
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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 |
|
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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. |
|
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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
|
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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. |