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Ovarian Tissue Cryopreservation in Pre-Pubertal (OTC-Pre Pubertal)
RecruitingObservational study
Ovarian Tissue Freezing for Fertility Preservation in Pre-Pubertal Children Facing a Fertility Threatening Medical Diagnosis or Treatment Regimen
Who can join
Up to age 11 · Women
Full eligibility criteria
Inclusion Criteria: * Pre- Pubertal Individual * Will undergo imminent surgery, chemotherapy or radiation therapy that has implications on future fertility and reproductive hormone potential: any health condition or malignancy that requires removal of all or part of one or both ovaries, whole abdomen or pelvic irradiation ≥10Gy in post-pubertal girls or ≥15Gy in pre-pubertal girls total body irradiation, and alkylating-intensive chemotherapy: * cyclophosphamide cumulative dose ≥7.5 g/m2 * any treatment regimen containing procarbazine * busulfan cumulative dose \>600 mg/m2 * 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 summed alkylating agent dose score ≥3 (Green et al., 2009) cyclophosphamide equivalent dose (CED) ≥ 4,000 mg/m2 (Green et al., 2014) Exclusion Criteria: * Patients with no anticipated oncologic therapies * Post-pubertal individuals * Pregnant children * Children with one ovary * Children deemed high risk for perioperative complications * Patients unable to provide consent/assent (i.e. significant psychiatric problems/cognitive delay)
About the study
The purpose of this study is to safely remove ovarian tissue in pre-pubertal pediatric patients, who are at risk for infertility from their medical treatment, for freezing for future restoration of fertility and hormone function.
What is being tested
- Laparoscopic surgery (procedure)
Sponsor: Erin Rowell · Participants: 250 · Started: May 29, 2018
Contact the study team
- Sara Reyes · Phone: 312-227-4145
Official record on ClinicalTrials.gov — NCT05299710
Locations in the U.S.
| Illinois | Ann & Robert H Lurie Childrens Hospital, Chicago |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.