| CTRI Number |
CTRI/2019/07/020140 [Registered on: 10/07/2019] Trial Registered Prospectively |
| Last Modified On: |
08/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Magnetic Activated Cells Sorted on ejaculated semen] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Sperm selection method by either TESA or MACS in cases with raised DNA fragmentation undergoing ICSI |
|
Scientific Title of Study
|
comparison of embryo parameters and reproductive outcome after sperm selection by MACS ( Magnetic Activated Cell Sorting ) or TESA ( Testicular Sperm Aspiration ) in cases with raised sperm DNA fragmentation undergoing ICSI ( cytoplasmic Sperm Injection) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prajna S |
| Designation |
FNB fellow in reproductive medicine |
| Affiliation |
Oasis center for reproductive medicine |
| Address |
Oasis Center for Reproductive Medicine
No.8-2-269/3/1/4
Near NATCO Pharma
Banjara Hills
Road No 2
Telangana
Hyderabad
TELANGANA
500034
India |
| Phone |
9845382286 |
| Fax |
|
| Email |
prajnashetty00@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Durga Rao |
| Designation |
Medical Director |
| Affiliation |
Oasis center for reproductive medicine |
| Address |
Oasis Center for Reproductive Medicine
No.8-2-269/3/1/4
Near NATCO Pharma
Banjara Hills
Road No 2
Telangana
Hyderabad
TELANGANA
500034
India |
| Phone |
9491111011 |
| Fax |
|
| Email |
durga@oasisindia.in |
|
Details of Contact Person
Public Query
|
| Name |
Prajna S |
| Designation |
FNB Fellow in reproductive medicine |
| Affiliation |
Oasis center for reproductive medicine |
| Address |
Oasis Center for Reproductive Medicine
No.8-2-269/3/1/4
Near NATCO Pharma
Banjara Hills
Road No 2
Telangana
Hyderabad
TELANGANA
500034
India |
| Phone |
9845382286 |
| Fax |
|
| Email |
prajnashetty00@gmail.com |
|
|
Source of Monetary or Material Support
|
| oasis center for reproductive medicine
No. 8-2-269/3/1/4
Near NATCO Pharma
Banjara Hills Road No. 2
Telangana
500034 |
|
|
Primary Sponsor
|
| Name |
Oasis center for reproductive medice |
| Address |
Oasis center for reproductive medicine
Near NATCO pharma
Banjara hills road no 2
Hyderabad |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Prajna S |
Oasis Center for reproductive Medicine |
No.8-2-269/3/1/4
Near NATCO Pharma
Banjara Hills
Road No 2
Telangana
Hyderabad
TELANGANA |
9845382286
prajnashetty00@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIMS Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N468||Other male infertility, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MACS (Magnetic Activated Cell Sorting ) |
-Semen processing is done by simple wash method.
-The resulted pellet is labeled with Annexin V microbeads followed by separation on MACS column
-The eluted column contains non apoptotic sperm suitable for oocyte injection .
-It is processed by double layer density gradient method.
-Processed sample is used for ICSI .
|
| Comparator Agent |
TESA (Testiculat Sperm Aspiration) |
-Testicular sperm aspiration done by using butterfly needle and 20cc syringe under General and Local anaesthesia.
-The extracted testicular tissue in the media will be mechanically minced using fine needles attached to tuberculin syringes to ensure wall breakdown and cellular content loss.
- Testicular sperm used in ICSI
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
1. DFI > 25% by SCSA method
2. Sperm count > 5mill/ml
3. Female aged 21-38yrs
4. History of poor IVF outcome or recurrent pregnancy loss |
|
| ExclusionCriteria |
| Details |
1. Recurrent Genital Tract Infection
2. Smoking
3. BMI > 35
4. Clinical varicocoele
5. Sperm donation
6. Presence of any of the endometrial / uterine factors that affect implantation
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blastocyst quality rate – defined as the assessment of blastocyst quality according to Gardners criteria. |
5th or 6th day after oocyte pickup |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blastulation rate – defined as the proportion of blastocysts formed on D5/6 over the cleaved embryos on D3. |
5th or 6th day after oocyte pickup |
| Implantation rate – Defined as number of gestational sac shown by Ultrasound in gestational week 6 per embryo transferred. |
4wks following embryo transfer |
| Clinical pregnancy rate – Defined as number of Gestational sac with fetal heart rate per embryo transfer cycle at 6-7wks GA. |
4-6 wks following embryo transfer |
| Miscarriage rate – Early loss of pregnancy before the 12th week of pregnancy |
12 wks of pregnancy |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
14/07/2019 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
DFI has emerged as an important biomarker of assessing male infertility potential . Various studies have found the association of raised DFI and negative clinical outcome in IVF /ICSI cycles. Various interventions have been proposed to alleviate DFI and / or to select sperm with higher quality chromatin . Out of all the interventions , spermatozoa retrieved from the testis of men with abnormal ejaculated sperm DNA integrity tend to have a better DNA quality . MACS (Magnetic Activated Cell Sorting) is another sperm selection technique that depends on binding of Annexin V to phosphatidyl serine which is a marker of apoptosis , giving a resulting (eluted )spermatozoa without DNA fragmentation . Limited studies are showing MACS helps in selecting sperm with less DFI . No studies have been done yet to compare the two different sperm selection technique.
The objective of the study is to compare the effectiveness of testicular sperm to MACS selected sperm in ICSI cycles , in patients with raised DFI. |