[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100463058":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":48,"collaborators":10,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":10,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":10,"maxAge":60,"enrollmentInfo":61,"targetDuration":64,"studyType":65,"phases":10,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":34,"whyStopped":10,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Ann & Robert H Lurie Children's Hospital of Chicago","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Ovarian Tissue Cryopreservation",null,"Children faced with a fertility threatening diagnosis will be offered ovarian tissue cryopreservation. Pre-surgery assessment will be done while the child is in the hospital or in the pediatric oncology, surgery, or anesthesia clinic as an outpatient. The surgical procedure used to remove the child's ovary is called laparoscopy. It is not required for the treatment of the child's cancer or other medical condition. Laparoscopic surgery is done under general anesthesia (the child will be asleep during the surgery) in the operating room.",[13],"Procedure: Laparoscopic surgery",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"PROCEDURE","Laparoscopic surgery","Surgery used to remove the child's ovary tissue is called laparoscopic surgery. Laparoscopic surgery employs a telescope-like instrument called laparoscope. The laparoscope will be put into the child's belly through a small (about half an inch) cut just below the belly button. Two or three other cuts may be made to allow for other instruments to help remove one of the ovaries. The surgeon will then look at both ovaries before the removal of one. Both of the child's ovaries must appear normal and be free of any masses in order to complete the surgery. The surgeon will choose which ovary will be removed at the time of surgery. This type of surgery is likely to last for 30 to 65 minutes.",[9],[21],{"name":22,"affiliation":23,"role":24},"Erin Rowell, MD","Lurie Childrens Hospital","STUDY_DIRECTOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Sara Reyes","CONTACT","312-227-4145","FertilityPreservation@luriechildrens.org",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Ann &Robert H Lurie Children's Hospital","RECRUITING","Chicago","Illinois","60611","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-87.65005,41.85003,{"lat":44,"lon":43},[47],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":10},{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Erin Rowell","Director of Fertility & Hormone Preservation & Restoration Program","100463058","ovarian-tissue-cryopreservation-in-post-pubertal-otc-post-pubertal-100463058",false,"NCT05309746","Ovarian Tissue Cryopreservation in Post Pubertal (OTC-Post Pubertal)","Ovarian Tissue Cryopreservation for Fertility Preservation in Post-Pubertal Children Facing a Fertility Threatening Diagnosis or Treatment Regimen","Inclusion Criteria:\n\n* Post-pubertal individuals \\\u003C 30 years of age\n* 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\n* total body irradiation, and\n* alkylating-intensive chemotherapy\n\n  * cyclophosphamide cumulative dose ≥7.5 g\u002Fm2\n  * any treatment regimen containing procarbazine\n  * busulfan cumulative dose \\>600 mg\u002Fm2\n  * alkylating chemotherapy conditioning prior to stem cell transplantation\n\n    * combination of any alkylating agent with total body irradiation or whole abdomen or pelvic radiation\n    * cranial radiation ≥30 Gy\n    * summed alkylating agent dose score ≥3 (Green et al., 2009)\n    * cyclophosphamide equivalent dose (CED) ≥ 4,000 mg\u002Fm2 (Green et al., 2014)\n* 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.\n\nExclusion Criteria:\n\n* Patients with no anticipated oncologic therapies\n* Pregnant children\n* Children with one ovary\n* Children deemed high risk for perioperative complications\n* Patients unable to provide consent\u002Fassent (i.e. significant psychiatric problems\u002Fcognitive delay)","FEMALE","30 Years",{"count":62,"type":63},250,"ESTIMATED","20 Years","OBSERVATIONAL","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.",[68],"Pediatric Cancer",[70,71],"OTC","fertility","2024-11-14",{"date":74,"type":75},"2024-11-18","ACTUAL",{"date":77,"type":75},"2017-11-01",{"date":79,"type":63},"2035-01",{"name":50,"class":6},1]