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Ovarian Tissue Cryopreservation in Pre-Pubertal (OTC-Pre Pubertal)
RECRUITINGSponsored by Erin Rowell
Actively Recruiting
SponsorErin Rowell
Started2018-05-29
Est. completion2030-12
Eligibility
SexFEMALE
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT05299710
Summary
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.
Eligibility
Sex: FEMALEHealthy volunteers accepted
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)
Conditions2
CancerCancers
Locations1 site
Ann & Robert H Lurie Childrens Hospital
Chicago, Illinois, 60611
Sara Reyes312-227-4145
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Actively Recruiting
SponsorErin Rowell
Started2018-05-29
Est. completion2030-12
Eligibility
SexFEMALE
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT05299710