| CTRI Number |
CTRI/2025/07/090955 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
01/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
A Study Comparing Two Sperm Selection Methods—PICSI and Microfluidics |
|
Scientific Title of Study
|
A Prospective Randomized Control Pilot Study to Evaluate the Effect
of Physiological Sperm Selection (PICSI) vs Microfluidics Sperm Selection (MFSS)
Preparation Methods by Using Sibling Oocytes with Normal Semen Parameters in Invitro Fertilization (IVF) Outcome |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajeshkumar Anandaraj |
| Designation |
Senior Embryologist |
| Affiliation |
A4 Hospitals and Fertility centre Pvt Ltd |
| Address |
Room no 10
Department of Embryology
87, Arcot Rd, AVM Avenue, Virugambakkam, Chennai, Tamil Nadu
Chennai
TAMIL NADU
600092
India |
| Phone |
9704555302 |
| Fax |
|
| Email |
labmanager@a4fertility.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajeshkumar Anandaraj |
| Designation |
Senior Embryologist |
| Affiliation |
A4 Hospitals and Fertility centre Pvt Ltd |
| Address |
Room no 10
Department of Embryology
87, Arcot Rd, AVM Avenue, Virugambakkam, Chennai, Tamil Nadu
TAMIL NADU
600092
India |
| Phone |
9704555302 |
| Fax |
|
| Email |
labmanager@a4fertility.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajeshkumar Anandaraj |
| Designation |
Senior Embryologist |
| Affiliation |
A4 Hospitals and Fertility centre Pvt Ltd |
| Address |
Room no 10
Department of Embryology
87, Arcot Rd, AVM Avenue, Virugambakkam, Chennai, Tamil Nadu
TAMIL NADU
600092
India |
| Phone |
9704555302 |
| Fax |
|
| Email |
labmanager@a4fertility.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rajesh Anandaraj |
| Address |
Department of Embryology
Room no 9 A4 Hospital and fertility centre No 87 Arcot Road, virugambakkam
Chennai 600092 |
| Type of Sponsor |
Other [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 Aruna R |
A4 Hospitals and Fertility centre Pvt Ltd |
Department of EmbryologyRoom no 9
87, Arcot Rd, AVM Avenue, Virugambakkam, Chennai, Tamil Nadu 600092
Chennai
TAMIL NADU |
09841269578
aruna@a4fertility.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| A4 Hospital - instituitional ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N979||Female infertility, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Density gradient Centrifugation (DGC) |
The Density Gradient Centrifugation (DGC) method is the universal gold standard procedure for semen preparation. The 80% and 40% Density gradient media are used for motile sperm seperation. |
| Comparator Agent |
Microfluidic sperm selection (MFSS) |
Low DNA Fragmented sperms swim up through MFSS layer from the raw semen sample. The swim up sample have low DNA Fragmented sperms.It will take around 7 days. |
| Intervention |
nil |
nil |
| Comparator Agent |
Physiological intra cytoplasmic sperm injection (PICSI) |
Physiological sperm selection by using Hyaluron coated intra cytoplasmic sperm injection(ICSI) Dish. Highly integrated DNA bind with hyaluron. The morphologically good hyaluron binded sperms used for ICSI. It will take around 7 days. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Matures Oocytes (M2) greater than 15.
Total Motile Sperm count greater than 2 million/ml
ICSI cycles
Self cycles with follicular phase stimulation
Only blast culture
Only antagonist cycle
Freshly ejaculated semen sample
Semen volume greater 1.5 ml
|
|
| ExclusionCriteria |
| Details |
Matured oocytes (M2) less than 15 oocytes
Total motile sperm count less than 2 mills/ml
Donor egg program
Donor sperm program
Surgically retrieved sperms
IVF cycles
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Blastocyst rate and Good Grade of blastocystÂ
|
8 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Euploidy Rate, Pregnancy rate, Ongoing pregnancy rate, Miscarriage rate. |
12 weeks of pregnancy |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
22/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/07/2025 |
| 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 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
|
The sperm used for ICSI procedure is prepared by 3 different techniques PICSI, MFSS, DGC. The sperm prepared by these 3 techniques were used with sibling oocytes of partner. Compared this outcome upto blast rate and good grade of blastocyst rate. |