Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-03-01 @ 3:17 AM
Study NCT ID:
NCT05066360
Status:
COMPLETED
Last Update Posted:
2024-01-29
First Post:
2021-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serum Antimullerian Hormone Levels Among Epileptic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'two groups (epileptic and healthy participants)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-26', 'studyFirstSubmitDate': '2021-07-02', 'studyFirstSubmitQcDate': '2021-10-01', 'lastUpdatePostDateStruct': {'date': '2024-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum anti-mullerian hormone levels', 'timeFrame': 'baseline, at the time of examination', 'description': 'The comparison of serum levels of anti-mullerian hormone between epileptic and healthy groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anti-mullerian hormone', 'epilepsy', 'adolescent'], 'conditions': ['Epilepsy', 'Reproductive Issues']}, 'referencesModule': {'references': [{'pmid': '21724534', 'type': 'BACKGROUND', 'citation': 'Karkanaki A, Vosnakis C, Panidis D. The clinical significance of anti-Mullerian hormone evaluation in gynecological endocrinology. Hormones (Athens). 2011 Apr-Jun;10(2):95-103. doi: 10.14310/horm.2002.1299.'}, {'pmid': '25585505', 'type': 'BACKGROUND', 'citation': 'Practice Committee of the American Society for Reproductive Medicine. Testing and interpreting measures of ovarian reserve: a committee opinion. Fertil Steril. 2015 Mar;103(3):e9-e17. doi: 10.1016/j.fertnstert.2014.12.093. Epub 2015 Jan 10.'}, {'pmid': '16388003', 'type': 'BACKGROUND', 'citation': 'Visser JA, de Jong FH, Laven JS, Themmen AP. Anti-Mullerian hormone: a new marker for ovarian function. Reproduction. 2006 Jan;131(1):1-9. doi: 10.1530/rep.1.00529.'}, {'pmid': '26753790', 'type': 'BACKGROUND', 'citation': 'Cimino I, Casoni F, Liu X, Messina A, Parkash J, Jamin SP, Catteau-Jonard S, Collier F, Baroncini M, Dewailly D, Pigny P, Prescott M, Campbell R, Herbison AE, Prevot V, Giacobini P. Novel role for anti-Mullerian hormone in the regulation of GnRH neuron excitability and hormone secretion. Nat Commun. 2016 Jan 12;7:10055. doi: 10.1038/ncomms10055.'}, {'pmid': '18796535', 'type': 'BACKGROUND', 'citation': 'Lebeurrier N, Launay S, Macrez R, Maubert E, Legros H, Leclerc A, Jamin SP, Picard JY, Marret S, Laudenbach V, Berger P, Sonderegger P, Ali C, di Clemente N, Vivien D. Anti-Mullerian-hormone-dependent regulation of the brain serine-protease inhibitor neuroserpin. J Cell Sci. 2008 Oct 15;121(Pt 20):3357-65. doi: 10.1242/jcs.031872. Epub 2008 Sep 16.'}, {'pmid': '23237902', 'type': 'BACKGROUND', 'citation': 'Harden CL, Pennell PB. Neuroendocrine considerations in the treatment of men and women with epilepsy. Lancet Neurol. 2013 Jan;12(1):72-83. doi: 10.1016/S1474-4422(12)70239-9.'}, {'pmid': '12939416', 'type': 'BACKGROUND', 'citation': 'Harden CL, Koppel BS, Herzog AG, Nikolov BG, Hauser WA. Seizure frequency is associated with age at menopause in women with epilepsy. Neurology. 2003 Aug 26;61(4):451-5. doi: 10.1212/01.wnl.0000081228.48016.44.'}, {'pmid': '8162389', 'type': 'BACKGROUND', 'citation': 'Meo R, Bilo L, Nappi C, Tommaselli AP, Valentino R, Nocerino C, Striano S, Buscaino GA. Derangement of the hypothalamic GnRH pulse generator in women with epilepsy. Seizure. 1993 Sep;2(3):241-52. doi: 10.1016/s1059-1311(05)80134-7.'}, {'pmid': '14595652', 'type': 'BACKGROUND', 'citation': 'Herzog AG, Coleman AE, Jacobs AR, Klein P, Friedman MN, Drislane FW, Ransil BJ, Schomer DL. Interictal EEG discharges, reproductive hormones, and menstrual disorders in epilepsy. Ann Neurol. 2003 Nov;54(5):625-37. doi: 10.1002/ana.10732.'}, {'pmid': '16981860', 'type': 'BACKGROUND', 'citation': 'Quigg M, Kiely JM, Johnson ML, Straume M, Bertram EH, Evans WS. Interictal and postictal circadian and ultradian luteinizing hormone secretion in men with temporal lobe epilepsy. Epilepsia. 2006 Sep;47(9):1452-9. doi: 10.1111/j.1528-1167.2006.00617.x.'}, {'pmid': '27565413', 'type': 'BACKGROUND', 'citation': 'Harden CL, Pennell PB, French JA, Davis A, Lau C, Llewellyn N, Kaufman B, Bagiella E, Kirshenbaum A. Anti-mullerian hormone is higher in seizure-free women with epilepsy compared to those with ongoing seizures. Epilepsy Res. 2016 Nov;127:66-71. doi: 10.1016/j.eplepsyres.2016.08.003. Epub 2016 Aug 17.'}]}, 'descriptionModule': {'briefSummary': 'The production of AMH starts in granulosa cells before birth and the levels within the serum decreases towards the menapouse. The levels of AMH do not change throughout the menstruation cycle hovewer, it can be affected in cases related to body mass index (BMI), polycyctic ovarian syndrome (PCOS). The lower levels of AMH had been documented after ovarian surgery, radiotheraphy and chemotheraphy. AMH is a member of Transforming Growth Faktor β (TGF- β ) and it has receptors in brain structures including hyppocammpus. It is highly active neurophysiologically and it has a protective effect against N-methyl-D -aspartate related neuronal injury that is demonstrated both in vivo and in vitro studies. As a result, being a neuroactive hormone; AMH may have an effect on seizures within epileptic patients or serum AMH levels may be effected in epileptic patients when compared with healthy ones.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy and epileptic volunteer females\n* Ages between 12-18\n* After menarche\n\nExclusion Criteria:\n\n* ovarian surgery,\n* history of radiotherapy\n* history of chemotherapy,\n* before menarche'}, 'identificationModule': {'nctId': 'NCT05066360', 'briefTitle': 'Serum Antimullerian Hormone Levels Among Epileptic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Near East University, Turkey'}, 'officialTitle': 'Investigation of Serum Antimullerian Hormone Levels in Adolescent Epilepsy Patients', 'orgStudyIdInfo': {'id': 'AMH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'participants with epilepsy', 'description': 'healthy, menstruating females between 12-18 ages', 'interventionNames': ['Diagnostic Test: serum antimullerian hormone']}, {'type': 'OTHER', 'label': 'healthy participants', 'description': 'epileptic, menstruating females between 12-18 ages', 'interventionNames': ['Diagnostic Test: serum antimullerian hormone']}], 'interventions': [{'name': 'serum antimullerian hormone', 'type': 'DIAGNOSTIC_TEST', 'description': 'serum antimullerian hormone will be analyzed for all participants', 'armGroupLabels': ['healthy participants', 'participants with epilepsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99138', 'city': 'Nicosia', 'country': 'Cyprus', 'facility': 'Near East University Faculty of Medicine', 'geoPoint': {'lat': 35.17284, 'lon': 33.35397}}], 'overallOfficials': [{'name': 'ALİ ÖZAY, Assoc Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Near East University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Serum antimullerian hormone levels will be shared for both groups'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Near East University, Turkey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor, Associate Professor', 'investigatorFullName': 'Ali Cenk', 'investigatorAffiliation': 'Near East University, Turkey'}}}}