Fertility Preservation In Young Female Cancer Survivors
- Conditions
- COVID 19 virus not identified,
- Registration Number
- CTRI/2023/02/049685
- Lead Sponsor
- Indian Council of Medical Research
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Female
- Target Recruitment
- 20
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparing the two methods of cryopreservation we shall assess the survival of cryo- All tissue samples will be assessed at baseline(control) and post thawing (6 months) preserved ovarian tissue by assessing: All tissue samples will be assessed at baseline(control) and post thawing (6 months) ï‚· Primordial follicle count All tissue samples will be assessed at baseline(control) and post thawing (6 months) ï‚· Proportion of viable primordial follicle All tissue samples will be assessed at baseline(control) and post thawing (6 months) ï‚· Extent of DNA damage to primordial follicles All tissue samples will be assessed at baseline(control) and post thawing (6 months)
- Secondary Outcome Measures
Name Time Method i)Proportion of intact or viable primordial follicles, ii)Primordial follicle density and DNA fragmentation in primordial follicles.
Trial Locations
- Locations (1)
All India Institute of Medical Sciences
🇮🇳South, DELHI, India
All India Institute of Medical Sciences🇮🇳South, DELHI, IndiaDr Neena MalhotraPrincipal investigator9891557707malhotraneena@yahoo.com