[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT01870752":3,"trial-entities:NCT01870752":94,"trial-summary:NCT01870752":99},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":34,"secondary_outcomes":40,"sex":48,"minimum_age":49,"maximum_age":50,"healthy_volunteers":15,"eligibility_criteria":51,"std_ages":67,"locations":69,"central_contacts":86,"overall_officials":89,"references":92,"see_also_links":93},"NCT01870752","UPCC 02813","Ovarian Tissue Transplantation","Autologous Orthotopic Transplantation of Previously Cryopreserved Ovarian Tissue","RECRUITING","2028-12","2025-09","2025-09-10","2013-06","Abramson Cancer Center at Penn Medicine","OTHER",false,"Chemotherapy and radiation therapy for the treatment of cancer can compromise fertility. Ovarian tissue cryopreservation is an experimental strategy offered at The University of Pennsylvania to preserve future fertility (protocol 806062). The primary objective of this study is to determine the efficacy and safety of autologous transplantation of previously cryopreserved ovarian cortical tissue in patients who experience infertility or ovarian insufficiency after cancer treatments.",null,[19],"Infertile Females or Females With Ovarian Insufficiency",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},10,"ESTIMATED",[29],{"type":30,"name":31,"armGroupLabels":32},"PROCEDURE","Transplantation of previously cryopreserved ovarian tissu",[33],"Transplantation of previously cryopreserved ovarian tissue",[35,38],{"measure":36,"timeFrame":37},"Pregnancy","5 years",{"measure":39,"timeFrame":37},"Return of menstrual function",[41,43,46],{"measure":42,"timeFrame":37},"Cancer recurrence",{"measure":44,"description":45,"timeFrame":37},"Surgical Complications of ovarian tissue transplantation","Including infection, hospital readmission, re-operation",{"measure":47,"timeFrame":37},"Acceptability","FEMALE","18 Years","45 Years",{"inclusion":52,"exclusion":60,"raw_text":66},[53,54,55,56,57,58,59],"Female patient between the ages of 18 and 45 years","Previously cryopreserved and stored cortical ovarian tissue available for autologous transplantation","Ovarian insufficiency defined as an elevated FSH over 10","Inability to conceive after 6 months of unprotected intercourse with male","Reasonably good health","Candidate for pregnancy","Written clearance for the procedure from the patients oncologist",[61,62,63,64,65],"Patients considered to be high risk for surgical complications will be excluded from the research protocol","Women who are known to be positive for the BRCA mutation","Women with a history of leukemia, ovarian cancer or a cancer that likely involved the ovaries at the time of ovarian tissue collection","Women with psychological, psychiatric, or other conditions which prevent giving fully informed consent","Current pregnancy","Inclusion Criteria:\n\n* Female patient between the ages of 18 and 45 years\n* Previously cryopreserved and stored cortical ovarian tissue available for autologous transplantation\n* Ovarian insufficiency defined as an elevated FSH over 10\n* Inability to conceive after 6 months of unprotected intercourse with male\n* Reasonably good health\n* Candidate for pregnancy\n* Written clearance for the procedure from the patients oncologist\n\nExclusion Criteria:\n\n* Patients considered to be high risk for surgical complications will be excluded from the research protocol\n* Women who are known to be positive for the BRCA mutation\n* Women with a history of leukemia, ovarian cancer or a cancer that likely involved the ovaries at the time of ovarian tissue collection\n* Women with psychological, psychiatric, or other conditions which prevent giving fully informed consent\n* Current pregnancy",[68],"ADULT",[70],{"facility":71,"status":8,"city":72,"state":73,"zip":74,"country":75,"contacts":76,"geoPoint":83},"Abramson Cancer Center of the University of Pennsylvania","Philadelphia","Pennsylvania","19104","United States",[77,81],{"name":78,"role":79,"phone":80},"Clarisa Gracia, MD","CONTACT","877-204-9213",{"name":78,"role":82},"PRINCIPAL_INVESTIGATOR",{"lat":84,"lon":85},39.95238,-75.16362,[87],{"name":78,"role":79,"phone":80,"email":88},"PennCancerTrials@emergingmed.com",[90],{"name":91,"affiliation":13,"role":82},"Clarisa R Gracia, MD",[],[],{"nct_id":4,"conditions":95,"biomarkers":98},[96,97],"Infertility","Ovarian Failure",[],{"nct_id":4,"found":100,"summary":101,"prompt_version":111},true,{"design":102,"status":103,"heading":104,"summary":105,"follow_up":106,"word_count":107,"commitments":108,"compensation":109,"drugs_mentioned":110},"This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 10 participants.","completed","Ovarian Tissue Transplantation for Infertility","This study is testing a procedure called ovarian tissue transplantation. This involves taking ovarian tissue that was previously frozen and transplanting it back into women who are infertile or have ovarian insufficiency (when ovaries don't work properly) after cancer treatments. The goal is to see if this procedure is safe and effective in helping women become pregnant and get their menstrual periods back. You might be able to join if you are a woman between 18 and 45 years old, have previously frozen ovarian tissue, have ovarian insufficiency (FSH over 10), and haven't been able to get pregnant after six months of unprotected intercourse. The study is currently unclear on its recruitment status and plans to enroll 10 participants.","Participants will be followed for pregnancy and return of menstrual function for 5 years.",119,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]