Actively Recruiting
Ovarian Tissue Cryopreservation in Pre-Pubertal (OTC-Pre Pubertal)
Led by Erin Rowell · Updated on 2024-11-18
250
Participants Needed
1
Research Sites
865 weeks
Total Duration
On this page
Sponsors
E
Erin Rowell
Lead Sponsor
A
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ovarian Tissue Cryopreservation in Pre-Pubertal (OTC-Pre Pubertal)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ann & Robert H Lurie Childrens Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
S
Sara Reyes
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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