| CTRI Number |
CTRI/2026/03/106589 [Registered on: 19/03/2026] Trial Registered Prospectively |
| Last Modified On: |
19/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Sperm DNA longevity over time period] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Sperm washing of samples and effect on DNA survival for Intra uterine insemination |
|
Scientific Title of Study
|
Impact of Post Wash Incubation Time on Sperm DNA Integrity in Normal and Abnormal Samples |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amandeep Kaur |
| Designation |
Lecturer |
| Affiliation |
Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka |
| Address |
Centre of Excellence in Clinical Embryology, Department of Reproductive Science, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9632223037 |
| Fax |
|
| Email |
amandeep.kaur@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Sonia Pinto |
| Designation |
PG student |
| Affiliation |
Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka |
| Address |
Centre of Excellence in Clinical Embryology, Department of Reproductive Science, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka
Amandeep Kaur, amandeep.kaur@manipal.edu, Centre of Excellence in Clinical Embryology, Department of Reproductive Science, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka
KARNATAKA
576104
India |
| Phone |
9632223037 |
| Fax |
|
| Email |
sonia.kmcmpl2024@learner.manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Amandeep Kaur |
| Designation |
Lecturer |
| Affiliation |
Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka |
| Address |
Centre of Excellence in Clinical Embryology, Department of Reproductive Science, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka
KARNATAKA
576104
India |
| Phone |
9632223037 |
| Fax |
|
| Email |
amandeep.kaur@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Amandeep Kaur |
| Address |
Centre of Excellence in Clinical Embryology, Department of Reproductive Science, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, 576104 |
| 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 |
| Dr Dhakshanya Predheepan |
Kasturba Medical College, MAHE, Manipal |
Department of Reproductive Science, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, 576104, Ground floor, Office room
Udupi
KARNATAKA |
08202923242
dhakshanyap.kmc@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Couples presenting at infertility clinic of Manipal Assisted Reproductive Centre, Kasturba Medical College, Manipal, for their routine semen analysis check up. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Abnormal sperm samples |
Normal sperm samples and their comparing with oligozoospermic sperm samples (meaning sperm concentration less than 16 million/ml as per WHO guidelines 2021). Assessing the DNA survival over time period comparing the normal sample and abnormal sample |
| Comparator Agent |
Normal sperm samples |
Normal sperm samples and their comparing with oligozoospermic sperm samples (meaning sperm concentration less than 16 million/ml as per WHO guidelines 2021). Assessing the DNA survival over time period comparing the normal sample and abnormal sample |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
normozoospermic and oligozoospermic semen samples which is Normozoospermic - having normal sperm concentration, motility as per WHO 2021 guidelines and oligozoospermic is less than the referecnes lower limit of sperm concentration of WHO 2021 |
|
| ExclusionCriteria |
| Details |
Asthenozoospermia - sperm motility less than the referenced limit of WHO 2021 guidelines , azoospermia - no sperm seen in the ejaculate referenced by WHO 2021 guidelines and surgically retrieved sperm by testicular tissue |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify and recover sperm with intact DNA after processing, determine the best time to use them for IUI |
The sperm sample assessment which will be of each sample and the assessment will be in hours only. that is 0 hour, 4 hour and 24 hour. the study will be done for all samples for 8 weeks |
|
|
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)
|
30/03/2026 |
| 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="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - NA
- For how long will this data be available start date provided 31-12-2025 and end date provided 30-08-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Sperm DNA fragmentation is increasingly recognised as a critical factor affecting male fertility, especially in Assisted Reproductive Technology ART like intrauterine insemination IUI. While sperm preparation methods such as swim-up and density gradient centrifugation help reduce initial DNA damage, the removal of seminal plasma may render spermatozoa more vulnerable to oxidative stress over time and this raises concern about stability of DNA integrity during common delays between sperm preparation and insemination. Existing studies have assessed sperm DNA fragmentation at a single time point or over short intervals, with limited data available on its progression beyond 3 hours post-processing. Moreover, these studies lack standardization and do not differentiate between normal and abnormal semen samples which is referenced by WHO 2021 guidelines. This study aims to evaluate DNA fragmentation at 0 hour, 4 hour and 24 hour after sperm preparation using sperm chromatin dispersion test SCD assay in samples to determine timing for clinic use. The assay will be carried out in department lab with in house preparation. |