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Brief Title: Ovarian Tissue Cryopreservation in Post Pubertal (OTC-Post Pubertal)
Official Title: Ovarian Tissue Cryopreservation for Fertility Preservation in Post-Pubertal Children Facing a Fertility Threatening Diagnosis or Treatment Regimen
Study ID: NCT05309746
Brief Summary: 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.
Detailed Description: Participants are invited to take part in this study because they will be treated with chemotherapy, radiation and/or surgery that will likely affect the child's ovaries and cause the child to become infertile (unable to become pregnant) in the future. The ovaries are reproductive glands found only in females. These glands are located in the pelvis (hip area). The ovaries produce eggs and female hormones. During each monthly menstrual cycle, an egg is released from one ovary. This study seeks to find out if removing an ovary in adolescents and children who have reached puberty, and who are about to undergo chemotherapy and/or radiation may preserve, or keep, their ability to have children in the future. The optional ovarian tissue that is removed for research will also be used to study better ways to store the ovarian tissue and to improve of the tissue in the future. This study has two parts: the removal of the ovarian tissue, and the storage of the ovarian tissue. A process called Ovarian Tissue Cryopreservation will be used to store the removed ovarian tissue. This kind of freezing is a special method that is used to try to prevent the eggs from being damaged, and to keep them frozen for a long time. The frozen tissue will be available to the child to be used at a later time. As a part of the study the investigator is asking participants to donate a 3-4mm biopsy (less than 10% of the ovary) of their ovarian tissue to future research before it is stored for their own use. The investigator also enrolls patients in a database study for yearly survey evaluation for long term outcome of ovarian tissue removal and potential restoration. Ovarian Tissue Cryopreservation involves a surgical procedure where ovarian tissue of post pubertal patients is surgically removed and frozen, with the ultimate goal that their tissue may be used in the future to restore fertility when experimental techniques emerge from the research pipeline. Participation in the study is voluntary.
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: FEMALE
Healthy Volunteers: No
Ann &Robert H Lurie Children's Hospital, Chicago, Illinois, United States
Name: Erin Rowell, MD
Affiliation: Lurie Childrens Hospital
Role: STUDY_DIRECTOR