Ovarian Tissue Cryopreservation in Pre-Pubertal (OTC-Pre Pubertal)
Recruiting now
Conditions studied: Cancers
In brief
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.
Key facts
- Study ID
- NCT05299710
- Run by
- Erin Rowell
- People needed
- 250
- Starts
- 2018-05-29
- Expected to finish
- 2035-01-01
- Last updated by the study team
- 2024-11-18
Who can join
Age: any, up to 11. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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)
Where it is running
- Ann & Robert H Lurie Childrens Hospital — Chicago, Illinois, United States (enrolling)
Full record on ClinicalTrials.gov
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