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CTRI Number  CTRI/2025/11/097006 [Registered on: 06/11/2025] Trial Registered Prospectively
Last Modified On: 04/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Impact of cancer on fertility 
Scientific Title of Study   Optimizing oncofertility:Evidence based protocols for cryopreservation of germ cells and gonadal tissue in adolescent cancer patients 
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 Satish Kumar Adiga  
Designation  Professor 
Affiliation  Kasturba Medical College 
Address  Department of Reproductive science, kasturba Medical college, Manipal Academy of Higher Education, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9945671115  
Fax    
Email  satish.adiga@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Shruthivishali Muthukumar 
Designation  PhD Student  
Affiliation  Kasturba Medical College 
Address  Department of Reproductive science, kasturba Medical college, Manipal Academy of Higher Education, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8072755518  
Fax    
Email  m.shruthivishali@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Satish Kumar Adiga  
Designation  Professor 
Affiliation  Kasturba Medical College 
Address  Department of Reproductive science, kasturba Medical college, Manipal Academy of Higher Education, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9945671115  
Fax    
Email  satish.adiga@manipal.edu  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  SAR health line Pvt limited  
Address  No. 48 / 1, G-1, Serenity Palace,New Avadi Road, Kilpauk, Chennai 600010, India. Tamilnadu 
Type of Sponsor  Other [private company] 
 
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 
Dr Satish Kumar Adiga  Kasturba Medical College  Room No: 14, Division of Clinical Embryology, Centre for fertility preservation, Department of Reproductive Science, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA 		 9945671115

satish.adiga@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Hospital Institutional Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  Patients will be included across all cancer types and stage between 15 – 39 years of age based on the puberty onset and reproductive lifespan respectively and without any genetic disorders affecting fertility.  
 
ExclusionCriteria 
Details  The exclusion criteria include patients with known sex chromosome genetic disorders across all cancers. Patients with relapse of cancer and who have undergone any gonadotoxic therapy prior to recruitment.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Understand the impact of cancer on germ cell reserve and quality   Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Understand the cryosuceptibility of sperm in relation to cancer type  3 YEARS 
 
Target Sample Size   Total Sample Size="210"
Sample Size from India="210" 
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)   30/11/2025 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  
Oncofertility involves the cryopreservation of germ cells and gonadal tissue but its efficacy to protect the germ cell from cancer affected patients is not clear due to interplay of critical factors during freeze and warming, such as cancer type, patient age, quality of germ cells and protocol employed. Despite advances and introduction of various adjuvants for cryoprotection gaps remain in techniques, access and clinical validation. Additionally, human sperm population in the ejaculate is highly heterogeneous rendering it extremely difficult to perform sperm selection for assisted reproduction. Due to precious nature of spermatozoa from cancer patients, we propose that additional cytological parameters may be considered to prevent iatrogenic damage to spermatozoa and to improve the effectiveness of sperm cryopreservation. Hence, it is imperative to better understand sperm physiology in men with cancer and to evaluate the effects of various steps in freezing. This will enable innovative strategies to define specific protocol to retain sperm functionality in cancer survivors. With this knowledge, new and effective evidence based ejaculate specific cryopreservation protocols can be designed.
 
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