Ovarian Tissue Cryopreservation in Post Pubertal (OTC-Post Pubertal)

Recruiting now

Conditions studied: Pediatric Cancer

In brief

The purpose of this study is to safely remove ovarian tissue in 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

NCT05309746

Run by

Erin Rowell

People needed

250

Starts

2017-11-01

Expected to finish

2035-01-01

Last updated by the study team

2024-11-18

Who can join

Age: any, up to 30. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Post-pubertal individuals < 30 years of age
• 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 ≥15 Gy 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)
• Patients may have newly diagnosed or relapsed disease. Those who were not enrolled at diagnosis are eligible even if they have received therapy that is viewed as likely to result in complete and permanent loss of ovarian function. However, these patients will be required to provide a 4mm punch biopsy of their tissue for research.

You may not qualify if…

• Patients with no anticipated oncologic therapies
• 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 Children's Hospital — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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