Ovarian Tissue Cryopreservation for Fertility Preservation in Pre and Post-Pubertal Children, Adolescents and Adults Facing a Fertility Threatening Diagnosis or Treatment Regimen
Amanda J. Saraf, DO
Primary Investigator
Brief description of study
- Define and follow-up with the patients that undergo OTC for fertility preservation.
- Optimize techniques and quality assurance measures for freezing and thawing of ovarian tissue or gametes
- Establish techniques for in vitro follicle maturation (IFM) or in vitro maturation of cumulus oocyte complexes
- Investigate factors affecting successful maturation of immature follicles obtained from ovarian tissue including the use of 3- dimensional biogel scaffolds, growth factors, hormones and other culture conditions,
- Optimize techniques for ovarian tissue transplantation, including improving vascularization and reducing the premature depletion of the ovarian reserve
- Define, investigate and establish other techniques that improve fertility and hormone preservation and restoration.
Only eligible patients that have been referred by a physician and seen by section of Pediatric Hematology/Oncology or Adolescent Medicine staff will be invited to participate in the clinical trial. Potential subjects will be contacted in the hospital or at a clinic visit in Pediatric Hematology/Oncology or Adolescent Medicine.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Cancer, Ovarian Tissue Cryopreservation, OTC, Riley
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Age: 17 years or below
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Gender: Female
Inclusion Criteria:
1. Pre-pubertal, peri-pubertal and post-pubertal individuals with ovaries of any age
2. Will undergo imminent surgery (which may include removal of one or both ovaries per standard of care), chemotherapy or radiation therapy that has implications on future fertility and reproductive hormone potential: 49
3. Receive whole abdomen or pelvic irradiation ≥10Gy in post-pubertal individuals or ≥15Gy in pre-pubertal individuals
4. Receive total body irradiation in combination with an alkylating agent
5. Receive alkylating-intensive chemotherapy for any health condition
cyclophosphamide cumulative or equivalent doses (CED) ≥ 8 g/m2 in pre-pubertal patients and ≥ 4 g/m2 in post-pubertal patients.
any treatment regimen containing procarbazine
alkylating chemotherapy conditioning prior to stem cell transplantation
combination of any alkylating agent with total body irradiation or whole abdomen or pelvic radiation
cranial radiation ≥30 Gy
6. Patients may have newly diagnosed or relapsed disease. Those who were not enrolled at diagnosis are eligible even if they have received therapy that is viewed as likely to result in complete and permanent loss of ovarian function.
Exclusion Criteria:
• Patients with no anticipated gonadotoxic therapies
• Patients with one ovary
• Patients deemed high risk for perioperative complications. This is a determination that would be made by either the surgeon or anesthesiologist evaluating each patient prior to consenting them for their respective portion of the procedure. This could include any medical condition (temporary or permanent) that would make it dangerous for the patient to undergo an abdominal procedure, anesthesia, etc.
