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CTRI Number  CTRI/2023/02/049685 [Registered on: 14/02/2023] Trial Registered Prospectively
Last Modified On: 16/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) 
Study Design  Single Arm Study 
Public Title of Study   Fertility Preservation In Young Female Cancer Survivors 
Scientific Title of Study   Ovarian tissue cryopreservation (OTC) for fertility preservation in young cancer survivors- Comparison of slow freezing and vitrification techniques 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neena Malhotra 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of obstetrics and Gynecology All India Institute of Medical Sciences

South
DELHI
110029
India 
Phone  9891557707  
Fax    
Email  malhotraneena@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Neena Malhotra 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of obstetrics and Gynecology All India Institute of Medical Sciences

South
DELHI
110029
India 
Phone  9891557707  
Fax    
Email  malhotraneena@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Neena Malhotra 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of obstetrics and Gynecology All India Institute of Medical Sciences

South
DELHI
110029
India 
Phone  9891557707  
Fax    
Email  malhotraneena@yahoo.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research 
 
Primary Sponsor  
Name  Indian Council of Medical Research  
Address  Indian Council of Medical Research Ansari Nagar New Delhi-29 
Type of Sponsor  Government funding agency 
 
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 Neena Malhotra  All India Institute of Medical Sciences  Department of obstetrics and Gynecology All India Institute of Medical Sciences
South
DELHI 
9891557707

malhotraneena@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: U072||COVID 19 virus not identified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control(Normal Tissue) No drugs are administered  Tissue prior to freezing will serve as a control 
Intervention  Technique of Cryopreservation  This is a technique for preservation of ovarian tissue for a lifetime. The two techniques are Slow freezing & Vitrification. No Drugs are administered. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  i) Patients with good prognosis for survival after chemo/radiotherapy requiring OTC

a. Pubertal ages with malignancy
b. Adults in reproductive years for immediate chemo/radiotherapy with little time for oocyte/embryo freezing as this requires 2-3 weeks of ovarian stimulation and oocyte recovery and embryo culture

ii) Willing to participate in the study
 
 
ExclusionCriteria 
Details  i) Patients with poor prognosis for survival
ii) Medical complications not permitting laparoscopy/anaesthesia to harvest ovarian tissue
iii) Not willing to participate in study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Comparing the two methods of cryopreservation we shall assess the survival of cryo-
preserved ovarian tissue by assessing:
ï‚· Primordial follicle count
ï‚· Proportion of viable primordial follicle
ï‚· Extent of DNA damage to primordial follicles 
All tissue samples will be assessed at baseline(control) and post thawing (6 months) 
 
Secondary Outcome  
Outcome  TimePoints 
i) Proportion of intact or viable primordial follicles,
ii) Primordial follicle density and DNA fragmentation in primordial follicles.
iii) The primordial follicle density and intactness will be checked at light microscopy and electron microscopy (TEM).
 
01 year
02 year
03 year 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   15/02/2023 
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)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Recent advancements have improved survival of cancer patients. Treatment is gonadotoxic resulting in loss of reproductive functions. Oncofertility involves managing cancer survivors with options of fertility preservation (FP) prior to chemo/radiotherapy. Options in females include stimulating ovaries and harvesting oocytes or creating embryos and freezing them in unmarried and married females respectively. This requires a hiatus of 2-3 weeks pre therapy. Oocyte and embryo cryopreservation are established methods of FP for adults. However, for pubertal and young girls who do not have sufficient mature oocytes ovarian tissue cryopreservation (OTC) and auto-transplantation is the only option.  OTC is still considered experimental, perhaps setting and standardization of techniques are challenging. The standard process of OTC has been slow freezing programmed with defined cryoprotectants. The other technique is vitrification which is associated with less cellular damage with no intra-cellular ice crystal formation. Though favoured for gametes and embryos, vitrification is still not widely accepted for OTC and studies comparing both techniques suggest conflicting results.

 
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