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Ovarian Tissue Freezing for Fertility Preservation in Pre-Pubertal Children Facing a Fertility Threatening Medical Diagnosis or Treatment Regimen

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: Female
Maximum Age: 11
Healthy Volunteers: f
View:

• 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)

Locations
United States
Illinois
Ann & Robert H Lurie Childrens Hospital
RECRUITING
Chicago
Contact Information
Primary
Sara Reyes
FertilityPreservation@luriechildrens.org
312-227-4145
Time Frame
Start Date: 2018-05-29
Estimated Completion Date: 2035-01
Participants
Target number of participants: 250
Treatments
Ovarian Tissue Cryopreservation
Children faced with a fertility threatening diagnosis will be offered ovarian tissue cryopreservation.Pre-surgery assessment will be done while your child is in the hospital or in the pediatric oncology, surgery, or anesthesia clinic as an outpatient. The surgical procedure used to remove your child's ovary is called laparoscopy. It is not required for the treatment of your child's cancer. Laparoscopic surgery is done under general anesthesia (your child will be asleep during the surgery) in the operating room.
Related Therapeutic Areas
Sponsors
Leads: Erin Rowell
Collaborators: Ann & Robert H Lurie Children's Hospital of Chicago

This content was sourced from clinicaltrials.gov