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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

Sponsor: Erin Rowell · Participants: 250 · Started: May 29, 2018

Contact the study team

Official record on ClinicalTrials.gov — NCT05299710

Locations in the U.S.

IllinoisAnn & 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.