[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"poi\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:poi":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"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":4,"briefSummary":24,"conditions":25,"keywords":35,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":4},"100637786","prospectivefemaleaya---late-effects-of-cancer-therapies-on-gonadal-function-fertility-efficiency-of-fertility-preservation-procedures-and-pregnancy-outcomes-100637786",false,"NCT07622420","ProspectiveFemaleAYA - Late Effects of Cancer Therapies on Gonadal Function, Fertility, Efficiency of Fertility Preservation Procedures and Pregnancy Outcomes","Late Effects of Cancer Therapies on Gonadal Function, Fertility, Efficiency of Fertility Preservation Procedures and Pregnancy Outcomes (ProspectiveFemaleAYA)","FemFertilAYA","Inclusion Criteria:\n\n* Female cancer patients aged between 15 and 39 years at diagnosis.\n* Receiving a diagnosis of primary cancer 01\u002F01\u002F2025 or later\n* Treated with chemotherapy and\u002For targeted therapy\u002Fimmunotherapy and\u002For radiotherapy\u002F radioactive iodine therapy and\u002For gynaecological surgery.\n* Detailed information on treatment received available.\n\nExclusion Criteria:\n\n* Pre-existing known POI at cancer diagnosis.\n* Treated by surgery alone (except gynaecological surgery).\n* Patients with relapse or secondary malignant neoplasms at time of inclusion or having received already treatments for cancer\n* Adult individuals subject of a measure of legal protection and\u002For patients with severe mental disorders.","FEMALE","15 Years","39 Years",{"count":21,"type":22},3000,"ESTIMATED","OBSERVATIONAL","In the past two decades, the evidence-based knowledge on the prevalence and risk factors for gonads impairment, including infertility, following cancer and numerous cancer treatment regimen has significantly increased. However, data remains mostly insufficient for individualized prediction of (future) fertility and pregnancy potential, including the use and success of artificial reproductive technologies (ART). Furthermore, therapies have become increasingly complex as more recent treatment regimen have continuously also implemented novel treatment approaches (e.g. immune therapies such as checkpoint inhibitors) for which no comprehensive data regarding its impact on fertility and pregnancy outcomes is available, yet.\n\nIt is crucial to carefully balance risk-benefit between fertility preservation (FP) procedures and potential of gonadal function\u002Ffertility impairment, to examine the efficiency and safety, as well as to assess patients' satisfaction regarding the FP procedures. Answering these questionsis highly relevant as it has been shown that fertility capacity and post-treatment gonadal function may represent a significant part of quality of life in young cancer survivors.\n\nThe study therefore aim to set up a large-scale registry of emerging data collection programmes to evaluate the gonadotoxic risks, including the prevalence and course of ovarian dysfunction and\u002For fertility impairment and premature ovarian insufficiency following specific treatments, identification of further risk factors and predictive markers to enhance precision survivorship research in this field. Additionally, data on the use of fertility preservation\u002Fhormonal treatment and patients' satisfaction related to these procedures in Europe will be analysed to support patient-centric care.\n\nReproductive health counselling should not be limited to evaluating the risk of gonadotoxicity and offering fertility preservation to those at risk. It should also include evaluating the impact on post-treatment sexuality, menopausal symptoms management, and the counselling on contraception.\n\nIn addition to clinical information, whole genome sequence data will be generated for selected study participants with evidence of varying impact of gonadotoxic therapies on reproductive function to find genetic variants associated with risk of reproductive and organ toxicity.\n\nThe data collection will focus on all different cancer diseases, including diseases which are less common such as different types of sarcomas. This will be a significant development to the current state of information in existing registries.\n\nThe primary objectives of this prospective analysis of European ongoing adolescent and young adult (AYA) cancer patient cohorts are:\n\n1. To establish a database with relevant clinical characteristics at time of diagnosis, cancer therapy received and post-cancer clinical and reproductive outcomes by following AYA cancer patients longitudinally.\n2. To evaluate the effect of cancer therapies on ovarian function and reproductive potential.\n3. To evaluate fertility preservation measures performed, their risks and efficacy.\n4. To evaluate the impact of fertility preservation measures on the risk of cancer relapse.\n5. To evaluate occurrence of pregnancies\u002Flive births naturally conceived (including unplanned) or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue.\n6. To set up a genetic database based on whole genome sequencing of AYAs of the cohort. For this objective a Substudy 1 : \" Development of risk prediction models based on clinical and genetic data \" will be conducted.\n7. To develop prediction models for organ toxicities in cancer patients (objective included in Substudy 1).\n8. To evaluate the effect of cancer therapies on sexuality and quality of life. For this objective a Substudy 2 : \"Sexual Health\" will be conducted.\n9. To evaluate the use and counselling on contraception. For this objective, a Substudy 3 : \"Contraception\" will be conducted.\n10. To describe management of treatment-induced premature ovarian insufficiency (POI) and menopausal symptoms. For this objective a Substudy 4 \"Management of POI and Menopause Symptoms\" will be conducted.\n11. To explore patient's satisfaction receiving counseling and\u002For undergoing fertility preservation. For this objective a Substudy 5 on \"Satisfaction with Fertility Preservation\" will be conducted.",[26,27,28,29,30,31,32,33,34],"Cancer","Cancer in Pregnancy","Infertility","In Vitro Fertilisation (IVF) Treatment","Late Effects","Quality of Life","Sexual Health Quality of Life","POI","Contraception Use",[36,37,38,39],"cancer therapy induced late effects","AYA cancer survivors","infertility as a late effect of cancer","late effects prediction","NOT_YET_RECRUITING","2026-05-27",{"date":43,"type":44},"2026-06-03","ACTUAL",{"date":46,"type":22},"2026-06-01",{"date":48,"type":22},"2035-05-31",{"name":50,"class":51},"Karolinska Institutet","OTHER",{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":59,"maxAge":19,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":4},"100477265","phase-1-safety-and-efficacy-of-yb-1113-in-treatment-of-poi-100477265","NCT05494723","Safety and Efficacy of YB-1113 in Treatment of POI","A Phase 1 Study of the Safety and Efficacy of YB-1113 in Treatment of Premature Ovarian Insufficiency (POI) Via Intravenous Infusion","Key Inclusion Criteria:\n\n1. Female, 18 to \\\u003C40 years old, who are seeking fertility or preservation of fertility\n2. Oligo\u002FAmenorrhea for at least 4 months\n3. At least two menopausal FSH levels (≥ 25 IU\u002FL) with 4 to 6 weeks interval.\n4. AMH levels ≤ 1.0 ng\u002FmL (measured on day 2-5 of the menstrual period).\n5. Subjects who are generally healthy by laboratory tests (normal complete blood count (CBC), comprehensive metabolic panel (CMP), and urinalysis) at screening\n6. For subjects who had contraception before, the duration of amenorrhea should be more than 3 months after discontinuation of the oral contraception pill (OCP) or more than 6 months after discontinuation of Depo Provera (or similar) therapies\n\nKey Exclusion Criteria:\n\n1. 1\\. Primary amenorrhea or FSH ≥ 40 IU\u002FL\n2. Presence of contraindications to pregnancy\n3. POI due to cytotoxic chemotherapy or radiation therapy\n4. Subjects with FMR1 premutation (fragile X syndrome), a BMP15 mutation or family history of POI\n5. Subjects under hormonal treatments including hormone replacement therapy (HRT) for osteoporosis, cardiovascular disease, or recalcitrant vasomotor symptomatology.\n6. Washout period less than 3 months for HRT.\n7. Subjects with a history of breast cancer or other estrogen responsive cancer.\n8. Subjects with existing malignant neoplasm, under active management for malignant neoplasm or under active surveillance for malignant neoplasm.\n9. Subjects with history of thromboembolic events such as pulmonary embolism, stroke, or ischemic heart disease\n10. Subjects with uncontrolled hypertension, kidney disease, liver disease, or polycystic ovary syndrome (PCOS)\n11. Subjects with endocrinopathies including Cushing's disease, thyroid disease, congenital adrenal hyperplasia and hyperprolactinemia.\n12. Subjects under active management for autoimmune disease.\n13. Subjects with intra-uterine devices (IUDs).\n14. Subjects who are pregnant, breastfeeding, or whose urinary pregnancy test is positive before participation in the study.\n15. Subjects who are allergic to low-molecular-weight heparin sodium or human albumin.\n16. Subjects with polyglandular autoimmune disease or other conditions require chronic administration of steroids higher than 30 mg\u002Fday of hydrocortisone or its equivalent\n17. Subjects with hereditary or acquirement coagulopathies, including but not limited to hemophilia, Von Willebrand disease, liver disease, Vitamin K deficiency, and platelet disorders.","18 Years",{"count":61,"type":22},6,"INTERVENTIONAL",[64],"PHASE1","This phase 1 study is to evaluate the safety and tolerability of YB-1113 administered via intravenous (IV) infusion in the treatment of premature ovarian insufficiency (POI).",[33],"2025-12-21",{"date":69,"type":44},"2025-12-23",{"date":71,"type":22},"2026-12-09",{"date":73,"type":22},"2028-04-09",{"name":75,"class":76},"Bright Cell, Inc.","INDUSTRY"]