NCT05299710 Ovarian Tissue Cryopreservation in Pre-Pubertal (OTC-Pre Pubertal)
| NCT ID | NCT05299710 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erin Rowell |
| Condition | Cancers |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2018-05-29 |
| Primary Completion | 2030-12 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief 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 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 i
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.