Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-02-27 @ 5:10 PM
Study NCT ID:
NCT04202094
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-04-01
First Post:
2019-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fertility in Young Adults Who Did (Not) Store Testicular Tissue Before a Treatment Leading to Fertility Problems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}], 'ancestors': [{'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D055101', 'term': 'Semen Analysis'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'This study is a prospective comparative interventional cohort study.\n\nThe fertility status of young adults (≥18 years) cured of childhood cancer or hematological disorders for which they received high-risk gonadotoxic treatment (with an ≥80% risk of later fertility problems) during childhood will be compared between patients who did and those who did not undergo a testicular tissue biopsy procedure at a young age as a fertility preservation strategy in order to identify a possible association between the biopsy procedure (which is performed to harvest testicular tissue) and the later fertility outcome.\n\nTheir fertility status will also be compared to the reproductive health of spontaneously conceived young adults that has already been published (Belva F et al., 2016/2017/2019).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2019-12-06', 'studyFirstSubmitQcDate': '2019-12-16', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of childhood gonadotoxic treatment on fertility status', 'timeFrame': 'at baseline and in 1 year', 'description': "The patients' fertility status (physical examination, scrotum ultrasound, blood sample, semen analysis) will be evaluated once a year after cessation of the gonadotoxic treatment. Only in case of infertility (azoospermia) or subfertility (oligo-, astheno- or teratozoospermia), the different interventions will be repeated one year later as the recovery of spermatogenesis with return of sperm production may occur several years after gonadotoxic treatment."}], 'secondaryOutcomes': [{'measure': 'Impact of testicular biopsy procedure (performed at a young age) on fertility status', 'timeFrame': 'at baseline and in 1 year', 'description': "The patients' fertility status (physical examination, scrotum ultrasound, blood sample, semen analysis) will be evaluated once a year after cessation of the gonadotoxic treatment. Only in case of infertility (azoospermia) or subfertility (oligo-, astheno- or teratozoospermia), the different interventions will be repeated one year later as the recovery of spermatogenesis with return of sperm production may occur several years after gonadotoxic treatment."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Male fertility preservation', 'Testicular tissue biopsy', 'Male fertility status', 'Tanner stage', 'Testicular volume', 'Hormones', 'Semen analysis'], 'conditions': ['Childhood Cancer', 'Hematological Disorders']}, 'referencesModule': {'references': [{'pmid': '37547664', 'type': 'BACKGROUND', 'citation': 'Delgouffe E, Braye A, Vloeberghs V, Mateizel I, Ernst C, Ferster A, Devalck C, Tournaye H, Gies I, Goossens E. Spermatogenesis after gonadotoxic childhood treatment: follow-up of 12 patients. Hum Reprod Open. 2023 Jul 31;2023(3):hoad029. doi: 10.1093/hropen/hoad029. eCollection 2023.'}, {'pmid': '27707840', 'type': 'BACKGROUND', 'citation': 'Belva F, Bonduelle M, Roelants M, Michielsen D, Van Steirteghem A, Verheyen G, Tournaye H. Semen quality of young adult ICSI offspring: the first results. Hum Reprod. 2016 Dec;31(12):2811-2820. doi: 10.1093/humrep/dew245. Epub 2016 Oct 5.'}, {'pmid': '28007789', 'type': 'BACKGROUND', 'citation': 'Belva F, Roelants M, De Schepper J, Van Steirteghem A, Tournaye H, Bonduelle M. Reproductive hormones of ICSI-conceived young adult men: the first results. Hum Reprod. 2017 Feb;32(2):439-446. doi: 10.1093/humrep/dew324. Epub 2016 Dec 21.'}, {'pmid': '30870183', 'type': 'BACKGROUND', 'citation': 'Belva F, Bonduelle M, Tournaye H. Endocrine and reproductive profile of boys and young adults conceived after ICSI. Curr Opin Obstet Gynecol. 2019 Jun;31(3):163-169. doi: 10.1097/GCO.0000000000000538.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this prospective comparative interventional cohort study is to assess the fertility status of young adult men (≥18 years) who received gonadotoxic treatment during childhood for the treatment of cancer or hematological disorders. These treatment protocols are highly gonadotoxic (i.e. they may cause later fertility problems) and therefore these patients have been proposed to store some testicular tissue during childhood as an option to preserve their fertility.\n\nThe main questions this study aims to answer are (1) the impact of the received gonadotoxic treatment on the later fertility status and (2) the additional impact of a testicular biopsy procedure (performed at a young age to harvest testicular tissue for storage) on the future fertility.\n\nParticipants will be asked to undergo a physical examination by a fertility specialist, to undergo a scrotal ultrasound, to give a blood sample, and to provide a semen sample.\n\nResearchers will compare the patients fertility status between the different received gonadotoxic treatment protocols, between patients who underwent a testicular biopsy procedure at a young age and those who did not, and compare the patients fertility status with the reproductive health of spontaneously conceived young adults.', 'detailedDescription': 'See the subsequent protocol sections.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* young adult men (≥18 years)\n* diagnosis of cancer or hematological disorder during childhood (\\<18 years)\n* high-risk gonadotoxic treatment received during childhood\n* at least one year after the last received genotoxic treatment\n* did/did not undergo a testicular biopsy procedure at a young age for fertility preservation\n\nExclusion criteria\n\n\\- prepubertal patients and adolescents (\\<18 years)'}, 'identificationModule': {'nctId': 'NCT04202094', 'briefTitle': 'Fertility in Young Adults Who Did (Not) Store Testicular Tissue Before a Treatment Leading to Fertility Problems', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'Follow-up of Fertility in Young Adults Who Did or Did Not Store Testicular Tissue Before Gonadotoxic Treatment for Fertility Preservation', 'orgStudyIdInfo': {'id': '2019-342'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biopsy group', 'description': 'Young adult men (≥18 years) cured of childhood cancer or hematological disorders for which they received high-risk gonadotoxic treatment during childhood and who have chosen to undergo a testicular biopsy procedure at a young age as a fertility preservation strategy.', 'interventionNames': ['Diagnostic Test: Physical examination', 'Diagnostic Test: Scrotum ultrasound', 'Diagnostic Test: Blood sample', 'Diagnostic Test: Semen analysis']}, {'type': 'EXPERIMENTAL', 'label': 'No biopsy group', 'description': 'Young adult men (≥18 years) cured of childhood cancer or hematological disorders for which they received high-risk gonadotoxic treatment during childhood and who have refused to undergo a testicular biopsy procedure at a young age as a fertility preservation strategy.', 'interventionNames': ['Diagnostic Test: Physical examination', 'Diagnostic Test: Scrotum ultrasound', 'Diagnostic Test: Blood sample', 'Diagnostic Test: Semen analysis']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Spontaneously conceived young adults whose data on reproductive health have already been published (Belva F et al., 2016/2017/2019).'}], 'interventions': [{'name': 'Physical examination', 'type': 'DIAGNOSTIC_TEST', 'description': "A physical examination to measure the patients' weight, height, body mass index, blood pressure and testicular volume using a Prader orchidometer and to determine the patients' Tanner stage (secondary sexual development).", 'armGroupLabels': ['Biopsy group', 'No biopsy group']}, {'name': 'Scrotum ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': "A scrotum ultrasound to measure the patients' testicular volume and to investigate potential abnormalities in the testicular parenchyma.", 'armGroupLabels': ['Biopsy group', 'No biopsy group']}, {'name': 'Blood sample', 'type': 'DIAGNOSTIC_TEST', 'description': 'A morning blood sample to evaluate the serum levels of luteinizing hormone (LH), follicle-stimulating hormone (FSH), testosterone (T), estradiol (E2), inhibin B (INHB), thyroid-stimulating hormone (TSH), free thyroxine (FT4), insulin-like growth factor 1 (IGF1), prolactin (PRL), cortisol and adrenocorticotropic hormone (ACTH). Upon approval by the patient himself, a spare blood sample will be collected and retained for 5 years for subsequent research purposes limited to the context of the present study.', 'armGroupLabels': ['Biopsy group', 'No biopsy group']}, {'name': 'Semen analysis', 'type': 'DIAGNOSTIC_TEST', 'description': 'A semen analysis to evaluate ejaculate volume, sperm concentration, sperm motility, and sperm morphology. If sperm is found in the semen sample, an anti-sperm antibody test and a sperm DNA fragmentation test will be performed. Upon approval by the patient himself, the surplus of the semen sample will be retained for 5 years for subsequent research purposes limited to the context of the present study.', 'armGroupLabels': ['Biopsy group', 'No biopsy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Ellen Goossens, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vrije Universiteit Brussel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vrije Universiteit Brussel', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of research group BITE', 'investigatorFullName': 'Ellen Goossens', 'investigatorAffiliation': 'Vrije Universiteit Brussel'}}}}