[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"oncofertility\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:oncofertility":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100625196","utero-ovarian-transposition-in-patients-with-pelvic-malignancies-undergoing-whole-pelvic-radiotherapy-100625196",false,"NCT07419490","Utero-ovarian Transposition in Patients With Pelvic Malignancies Undergoing Whole Pelvic Radiotherapy","A Phase I Assessment of Utero-ovarian Transposition (UOT) for Fertility Preservation in Patients With Pelvic Malignancies Undergoing Whole Pelvic Radiotherapy (WPXRT)","UOT WPXRT","Inclusion Criteria:\n\n1. Age: Women 18 - 40 years of age who wish to preserve their fertility.\n2. Malignancy: Diagnosis of pelvic malignancies that require radiotherapy, including:\n\n   1. Colon and rectal cancer with tumors.\n   2. Anal cancer.\n   3. Other pelvic malignancies that require administration of WPXRT.\n3. Desire for Fertility Preservation: The patient expresses a clear desire to preserve fertility and the ability to carry a pregnancy in the future.\n4. Preoperative Ovarian Function: The patient must have normal ovarian function, demonstrated by specific hormonal values, including:\n\n   1. Follicle-Stimulating Hormone (FSH): \\\u003C10 IU\u002FL\n   2. Luteinizing Hormone (LH): within normal reference range for reproductive age (typically 1.5-8 IU\u002FL in the early follicular phase).\n   3. Anti-Müllerian Hormone (AMH): \\>1 ng\u002FmL\n   4. Estradiol (E2): within the normal range for the follicular phase (usually 30-120 pg\u002FmL).\n5. No Distant Metastasis: Absence of metastatic disease confirmed by imaging (CT, MRI, or PET scans).\n6. Body Mass Index (BMI) \\\u003C 35.\n7. Signed Informed Consent.\n\nExclusion Criteria:\n\n1. Advanced Cancer Stage: Patients with locally advanced or metastatic disease.\n2. Significant Uterine Pathology: Presence of large uterine fibroids, adenomyosis, or other intrauterine pathologies that would complicate the procedure or future pregnancy.\n3. Poor General Health or Comorbidities: Severe medical conditions that contraindicate surgical intervention, that include but not limited to:\n\n   * Cardiovascular Disease:\n\n     1. Recent (within 6 months) myocardial infarction (MI).\n     2. Ejection fraction (EF): EF \\\u003C30%.\n     3. Uncontrolled hypertension: Systolic BP \\>180 mmHg or Diastolic BP \\>110 mmHg prior to surgery.\n     4. Severe aortic stenosis: Valve area \\\u003C1 cm² with symptomatic status.\n   * Uncontrolled Diabetes Mellitus:\n\n     1. Hemoglobin A1c (HbA1c) \\> 9%\n     2. Persistent fasting glucose \\>250 mg\u002FdL preoperatively despite optimization.\n   * Severe Respiratory Diseases:\n\n     1. Forced expiratory volume (FEV1): \\\u003C50%.\n     2. Oxygen saturation: Resting SpO₂ \\\u003C88% on room air without supplemental oxygen.\n     3. CO2 retention: PaCO₂ \\>50 mmHg.\n   * Connective Tissue Disorders:\n\n     1. Severe systemic lupus erythematosus (SLE): Active lupus nephritis with GFR \\\u003C30 mL\u002Fmin.\n     2. Scleroderma with severe pulmonary hypertension or FVC \\\u003C50% predicted.\n     3. Rheumatoid arthritis with severe cervical spine instability (atlantoaxial subluxation).\n   * Severe Inflammatory Bowel Disease (IBD):\n\n     1. Severe Crohn's or ulcerative colitis flares with C-reactive protein (CRP) \\>10 mg\u002FL and hypoalbuminemia (Albumin \\\u003C2.5 g\u002FdL).\n     2. Severe malnutrition: BMI \\\u003C18.5 kg\u002Fm² or Prealbumin \\\u003C10 mg\u002FdL\n   * Steroid dependency:\n\n     1. Chronic steroid use (\\>20 mg prednisone daily) with no feasible taper pre-surgery.\n4. Prior Pelvic Radiotherapy.\n5. Prior history of systemic chemotherapy and immunotherapy that resulted in significant toxicity and residual deficit.\n6. Pregnancy: Patients who are currently pregnant are excluded from consideration for uterine transposition.\n7. Unsuitable for Ovarian Function Preservation: Women with signs of poor ovarian reserve, including:\n\n   * FSH: \\>10 IU\u002FL\n   * AMH: \\\u003C1 ng\u002FmL\n   * Estradiol: outside normal range.\n8. Non-Candidate for Fertility: Patients with contraindications to future pregnancy, such as severe uterine abnormalities or significant risk for pregnancy-related complications.\n9. Body Mass Index (BMI) ≥35.\n10. Absence of One of the Gonadal Vessels.\n11. Other unlisted conditions or diagnoses that, in the opinion of the primary investigator, render the patient an unsuitable candidate for uteroovarian transposition.","FEMALE","18 Months","40 Months",{"count":21,"type":22},26,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study is designed as a Phase I clinical trial enrolling female patients aged 18-40 years who have been diagnosed with pelvic malignancies requiring whole pelvic external radiation therapy (WPXRT) and who express interest in preserving fertility and ovarian function.\n\nThe trial's primary objective is to assess the feasibility and safety of uterine and ovarian transposition (UOT). Premenopausal women under the age of 40 will undergo UOT using a novel minimally invasive approach.\n\nFeasibility and safety will be evaluated through standardized postoperative assessments, including:\n\n(A) success in mobilizing and repositioning the uterus, ovaries, and fallopian tubes while maintaining vascular integrity; (B) documentation of surgical complications; (C) monitoring the timeliness and adherence to planned WPXRT.\n\nTo enhance safety and optimize outcomes, intraoperative imaging with indocyanine green fluorescence and Doppler ultrasonography will be employed.\n\nShort-term success will be defined by technical success in repositioning the uterus and ovaries with preserved vascular integrity, absence of major surgical complications, and timely initiation and completion of WPXRT.\n\nLong-term success will be evaluated by the preservation of fertility.\n\nThe study's primary objective is also to evaluate surgical, reproductive, and quality-of-life outcomes following UOT. This objective will determine the procedure's efficacy in preserving ovarian and menstrual function and its potential to support future pregnancies.\n\nEndpoints include:\n\n(A) maintenance of normal premenopausal levels of FSH, LH, AMH, and estradiol at defined postoperative intervals; (B) assessment of menstrual timing, regularity, and characteristics to document return of ovulatory cycles; (C) evaluation of uterine integrity and reproductive potential using pelvic ultrasonography; (D) comprehensive evaluation of patient quality of life encompassing physical, emotional, sexual, and reproductive well-being.\n\nThese measures will inform optimization of surgical techniques and provide a foundation for scaling the procedure to a broader population in future studies.",[28,29,30],"Colorectal (Colon or Rectal) Cancer","Pelvic Malignancies","Oncofertility",[32,33,34,35,36,37,38,39],"uterine transposition","utero-ovarian transposition","oncofertility","pelvic radiation","pelvic malignancies","rectal cancer","colorectal malignancies","fertility preservation","RECRUITING","2026-06-23",{"date":43,"type":44},"2026-06-24","ACTUAL",{"date":46,"type":44},"2026-04-01",{"date":48,"type":22},"2031-06",{"name":50,"class":51},"University of South Florida","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":66,"phases":4,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":52},"100639141","outcomes-for-patients-who-preserved-their-fertility-as-part-of-cancer-treatment-at-the-center-for-the-study-and-preservation-of-eggs-and-sperm-mapreservferti-100639141","NCT07601451","Outcomes for Patients Who Preserved Their Fertility as Part of Cancer Treatment at the Center for the Study and Preservation of Eggs and Sperm: MaPreservFerti","Outcomes for Patients Who Preserved Their Fertility as Part of Cancer Treatment at the Center for the Study and Preservation of Eggs and Sperm (CECOS) in Lyon Between 2010 and 2024: an Assessment of Male Parenthood. MaPreservFerti","MaPreservFerti","Inclusion Criteria:\n\n* were between the ages of 18 and 60 at the time of fertility preservation\n* Underwent fertility preservation at the CECOS in Lyon between January 1, 2010, and December 31, 2024.\n* underwent fertility preservation in the context of cancer treatment\n* who have indicated their consent to participate in the study by completing the questionnaire\n\nExclusion Criteria:\n\n* Persons deprived of their liberty by a judicial or administrative decision\n* Persons receiving psychiatric care\n* Persons admitted to a health or social care facility for purposes other than research\n* Adults subject to a legal protection measure (guardianship, conservatorship)","MALE","18 Years","60 Years",{"count":65,"type":22},950,"OBSERVATIONAL","Improvements in diagnostic methods and cancer treatments have led to a steady increase in survival rates. The 5-year survival rate for men diagnosed with cancer between the ages of 15 and 39 has exceeded 81%. As a result, quality of life-and in particular, addressing the issue of parenthood-has become essential.\n\nCancer treatments-surgery, radiation therapy, and chemotherapy-can significantly impair fertility. They may cause sexual dysfunction (anejaculation, anerection), androgen deficiency, or permanent impairment of spermatogenesis. Yet the desire for parenthood ranks among the top three life goals of patients newly diagnosed with cancer, and 50% of patients wish to have a child in the future. Preserving male fertility is therefore a crucial issue.\n\nBefore puberty, this can be done by taking a testicular tissue sample, although this is still considered experimental. After puberty, a sample taken from ejaculate allows for the storage of sperm straws.\n\nThus, when a couple wishes to conceive, following a potential reassessment of spermatogenesis if it is impaired, Assisted Reproductive Technology (ART) can be performed with or without the frozen sperm.\n\nAccording to the literature, the sperm is typically used within 10 years of fertility preservation. Little data has been collected regarding whether men with a history of cancer conceive naturally or not. It is therefore important to gather this information regarding fatherhood, particularly whether men with a history of cancer have used ART or not, and whether frozen sperm was used or not, based on the results of the follow-up semen analysis performed after treatment.\n\nPrimary objective To describe fertility-whether spontaneous or following assisted reproductive technology (ART)-with or without the use of preserved gametes, among patients who underwent fertility preservation for cancer treatment at the CECOS in Lyon between 2010 and 2024.\n\nSecondary objective:\n\nTo assess the population of men who preserved their fertility prior to cancer treatment at the Center for the Study and Preservation of Eggs and Sperm (CECOS) in Lyon between 2010 and 2024, specifically:\n\n* The number and clinical and epidemiological characteristics of the patients.\n* Describe post-cancer fertility\n* Understand CECOS's care protocols to improve the patient care pathway.\n* Describe the psychological difficulties at the time of collection that prevented the procedure and thus the preservation of fertility.\n* Determine the fate of preserved straws that were not used\n\nMethodology:\n\n* Retrospective analysis of data from the CECOS in Lyon between 2010 and 2024.\n* Information collected from the database: patient age, indication, type of fertility preservation performed (testicular tissue or ejaculate)\n* Subsequently, a paper and electronic questionnaire was sent to these same patients to collect data on their fertility following fertility preservation.\n* Information collected via the questionnaires: marital status, place of residence, paternity prior to cancer, type of cancer, treatment received, achievement of pregnancy after cancer and method (spontaneous pregnancy, reuse of straws at the center, or ART at another center), donation of gametes to research, or destruction if unused.\n\nThe CECOS in Lyon is an integral part of the Department of Reproductive Medicine and Biology at the Hopsices Civils de Lyon.\n\nPopulation studied: This study focuses on patients with a history of cancer who underwent gonadotoxic treatment and preserved their fertility at the CECOS in Lyon between 2010 and 2024\n\nInclusion criteria:\n\nThis study will include patients who:\n\n* were between the ages of 18 and 60 at the time of fertility preservation\n* underwent fertility preservation at the CECOS in Lyon between January 1, 2010, and December 31, 2024.\n* underwent fertility preservation in the context of cancer treatment\n* who have indicated their consent to participate in the study by completing the questionnaire\n\nExclusion criteria:\n\n* Persons deprived of their liberty by a judicial or administrative decision\n* Persons receiving psychiatric care\n* Persons admitted to a health or social care facility for purposes other than research\n* Adults subject to a legal protection measure (guardianship, conservatorship)\n\nProcedure:\n\nAn information sheet will be sent to patients regarding the analysis of their medical data collected during their care, along with a questionnaire (see attached questionnaire) for the collection of prospective data. The materials will be sent either by mail (with a stamped envelope for free return shipping as part of the study) or electronically via a dedicated and secure CECOS email address for email responses.\n\nNumber of subjects : 950 Study duration : 1 year\n\nStudy location : Center for the Study and Preservation of Eggs and Sperm (CECOS)",[69,70,30],"Fertility","Male Cancer",[72,30,73,74],"Male cancer treatment","Male fertility preservation","Sperm cryopreservation","NOT_YET_RECRUITING","2026-05-15",{"date":78,"type":44},"2026-05-22",{"date":80,"type":22},"2026-06",{"date":82,"type":22},"2027-06",{"name":84,"class":51},"Hospices Civils de Lyon"]