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
|
|
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
|
|
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. |