[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06710769":3,"trial-entities:NCT06710769":79,"trial-summary:NCT06710769":83},{"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":7,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":14,"phases":21,"enrollment_info":23,"interventions":26,"primary_outcomes":33,"secondary_outcomes":38,"sex":39,"minimum_age":40,"maximum_age":41,"healthy_volunteers":15,"eligibility_criteria":42,"std_ages":48,"locations":51,"central_contacts":71,"overall_officials":76,"references":77,"see_also_links":78},"NCT06710769","19-195","Ovarian Tissue Cryopreservation","Ovarian Tissue Freezing For Fertility Preservation In Girls Facing A Fertility Threatening Medical Diagnosis Or Treatment Regimen","RECRUITING","2031-07","2026-01","2026-01-23","2020-07-30","Phoenix Children's Hospital","OTHER",false,"Cancer is a health concern; however, science advancement in disease detection and treatment modalities continues to improve patient survival rates. Cancer treatment consequences are gaining importance for survivors, families and providers. Infertility is a primary concern among female cancer survivors as it not only has biological implications, but psychosocial implications as well. Cancer treatment can cause acute ovarian failure, premature menopause and results in reproductive challenges in survivorship. Females who are approaching reproductive age at time of cancer diagnosis, who receive abdominopelvic radiation or high dose alkylating agents and those diagnosed with Hodgkin's lymphoma have increased risk for infertility following treatment. Cancer treatment is not the only treatment that threatens reproductive capacity, but rheumatoid arthritis and lupus treatment may also cause infertility.\n\nFemale cancer patients express fertility preservation is extremely important for their long-term psychosocial health. The current American Society for Clinical Oncology Clinical Practice Guideline states that all patients should be made aware of possible side effects of treatment on fertility, and that patients be offered fertility preservation interventions. Embryo banking or egg banking (oocyte preservation) prior to chemotherapy is the most successful options for fertility preservation in women. This option necessitates time for ovarian stimulation and retrieval which can take up to 2-3 weeks and is costly. This option may be longer for those who acquire ovarian hyper-stimulation syndrome and younger patients have a higher risk for OHSS. Embryo banking requires mature oocytes and can cause emotional and physical stress. The financial and physical challenges with fertility preservation motivate the desire to find alternatives for young cancer patients.\n\nImproved freezing and thawing techniques for human oocytes have contributed to pregnancy rates comparable to those using fresh egg following in vitro fertilization. Prior to ovarian tissue cryopreservation there was no fertility preservation intervention available to patients who could not delay treatment or were too young to undergo hormonal stimulation. As of 2017, greater than 130 live births following transplantation of frozen\u002Fthawed ovarian tissue have been reported. Ovarian tissue cryopreservation has proven to be a safe and efficient method for preserving future fertility for patients undergoing potentially sterilizing treatments. Ovarian tissue cryopreservation is a standard-of-care in parts of Europe and is routine in several children's hospitals throughout the United States. We propose this option be available to qualifying patients at Phoenix Children's Hospital.",[18],"Infertility, Female",[],"INTERVENTIONAL",[22],"NA",{"count":24,"type":25},40,"ESTIMATED",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31},"PROCEDURE","Ovarian tissue removal will be performed laparoscopically","under general anesthesia concomitantly with another scheduled procedure if possible. Following removal, ovarian tissue will be shipped to University of Pittsburg Medical Center, Magee-Womens Research Institute for processing. Freezing and storing techniques will be in accordance with FDA regulations for reproductive tissues, guidelines of the American Association of Tissues Banks and any other applicable federal, state and local regulations. The tissue will be carefully separated dividing the cortex from the medulla. The cortex will then be cryopreserved for long term storage. The medulla will be shipped overnight back to the PCH Department of Pathology for histological evaluation. If pathology finds evidence of cancer in the ovarian tissue provided, they may request that all of the patient's tissue be returned to pathology for a more detailed examination, which may eliminate the tissue available for the patient's future use.",[32],"girls facing possible infertility",[34],{"measure":35,"description":36,"timeFrame":37},"Percentage of patients who utilize their ovarian tissue and the age at which they use it will be evaluated. The number of patients who elect to have OTC will be analyzed over time to identify trends.","data will be investigated via qualitative analysis.","10 years",[],"FEMALE","1 Year","25 Years",{"inclusion":43,"exclusion":45,"raw_text":47},[44],"Newly diagnosed or relapsed malignancy with proposed treatment regimen containing at least ONE (1) of the following:",[46],"Pregnancy or a patient who is currently breastfeeding","Inclusion Criteria:\n\n* Newly diagnosed or relapsed malignancy with proposed treatment regimen containing at least ONE (1) of the following:\n\nwhole abdomen or pelvic irradiation\n\ntotal body irradiation\n\nProposed treatment regimen to include any of the following:\n\ncyclophosphamide equivalent dose (CED, see Green et al 2014) ≥7.5 g\u002Fm2\n\nany treatment regimen containing procarbazine\n\nbone marrow transplant conditioning regimen containing alkylators\n\nOR health condition or malignancy that requires removal of one or both ovaries. Health status adequate to undergo elective laparoscopic surgery (as per anesthesiologist assessment)\n\nExclusion Criteria:\n\n* Pregnancy or a patient who is currently breastfeeding\n\nPatients who are eligible for and agree to oocyte preservation\n\nAnyone deemed high risk for complications from the surgery and\u002For anesthesia.\n\nAnyone unable to provide consent due to psychiatric conditions or cognitive delay (in parent\u002Fguardian for patients \\\u003C18 years, and patient \\>18 years)",[49,50],"CHILD","ADULT",[52],{"facility":53,"status":8,"city":54,"state":55,"zip":56,"country":57,"contacts":58,"geoPoint":68},"Phoenix Childrens","Phoenix","Arizona","85016","United States",[59,64],{"name":60,"role":61,"phone":62,"email":63},"Alexandra Walsh, MD","CONTACT","6029330916","awalsh@phoenixchildrens.com",{"name":65,"role":61,"phone":66,"email":67},"Briana Fodor, BS","6029332548","bfodor@phoenixchildrens.com",{"lat":69,"lon":70},33.44838,-112.07404,[72,74],{"name":60,"role":61,"phone":73,"email":63},"602-933-4483",{"name":75,"role":61,"phone":73,"email":67},"Briana Fodor",[],[],[],{"nct_id":4,"conditions":80,"biomarkers":82},[81],"Infertility",[],{"nct_id":4,"found":84,"summary":85,"prompt_version":95},true,{"design":86,"status":87,"heading":88,"summary":89,"follow_up":90,"word_count":91,"commitments":92,"compensation":93,"drugs_mentioned":94},"This is an interventional study planning to enroll 40 female participants between 1 and 25 years old.","completed","Ovarian Tissue Cryopreservation for Fertility Preservation","This study is looking at ovarian tissue cryopreservation (freezing ovarian tissue) as a way to help young women preserve their fertility. Many cancer treatments, and treatments for conditions like rheumatoid arthritis and lupus, can harm a woman's ability to have children later. This study aims to understand how many patients choose to have their ovarian tissue frozen and when they decide to use it. You might be able to join if you are a female between 1 and 25 years old, have a new cancer diagnosis or a cancer that has returned, and your treatment plan includes certain types of radiation or high doses of cyclophosphamide. The main goal is to track how many patients use their frozen ovarian tissue and their age at that time, over a 10-year period.","The study will track the use of ovarian tissue and age of use for 10 years.",130,"Participants will have ovarian tissue removed through a laparoscopic procedure (a type of surgery using small incisions) under general anesthesia, ideally during another planned surgery.","Not stated in the trial record.",[],"v2"]