Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-02-11 @ 5:02 AM
Study NCT ID:
NCT02098668
Status:
COMPLETED
Last Update Posted:
2016-09-07
First Post:
2013-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mathematical Model for the Human Menstrual Cycle, Endocrinological Diseases and Fertility Treatment-PAEON
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D004715', 'term': 'Endometriosis'}, {'id': 'D006966', 'term': 'Hyperprolactinemia'}, {'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006964', 'term': 'Hyperpituitarism'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Probes to determine hormonal parameters'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-06', 'studyFirstSubmitDate': '2013-06-18', 'studyFirstSubmitQcDate': '2014-03-25', 'lastUpdatePostDateStruct': {'date': '2016-09-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Dynamics of gyneco-endocrinological diseases', 'timeFrame': '3 years', 'description': 'To better understand the pathophysiological mechanisms in endocrinological diseases'}], 'primaryOutcomes': [{'measure': 'Hormonal parameters', 'timeFrame': '3 years', 'description': 'Development of a mathematical model of the menstrual cycle'}], 'secondaryOutcomes': [{'measure': 'Dynamics of fertility treatment', 'timeFrame': '2 years', 'description': 'Mathematical model to improve fertility treatments'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['menstrual cycle dynamics', 'PCOS', 'hyperprolactinemia', 'endometriosis', 'infertility'], 'conditions': ['Polycystic Ovary Syndrome', 'Endometriosis', 'Hyperprolactinemia']}, 'referencesModule': {'references': [{'pmid': '31244718', 'type': 'DERIVED', 'citation': 'Leeners B, Kruger THC, Geraedts K, Tronci E, Mancini T, Egli M, Roblitz S, Saleh L, Spanaus K, Schippert C, Zhang Y, Ille F. Associations Between Natural Physiological and Supraphysiological Estradiol Levels and Stress Perception. Front Psychol. 2019 Jun 11;10:1296. doi: 10.3389/fpsyg.2019.01296. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'Development of a bio-mathematical model of the human female cycle', 'detailedDescription': 'From hormonal measurements throughout 1-2 menstrual cycles in women with and without endocrinological pathology a mathematical model of the human menstrual cycle will be generated. The model will serve to predict development of the cycle including ovulation as well as to better understand the pathophysiology of endocrinological disorder. In a second step current treatment protocols for fertility treatment will be integrated into the model in order to optimize treatment outcome.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '43 Years', 'minimumAge': '18 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women with normal and distrubed menstrual cycles Women receiving fertility treatment', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n\\- Women during their reproductive phase, no hormonal therapy\n\nExclusion criteria:\n\n\\- Amenorrhoae'}, 'identificationModule': {'nctId': 'NCT02098668', 'acronym': 'PAEON', 'briefTitle': 'Mathematical Model for the Human Menstrual Cycle, Endocrinological Diseases and Fertility Treatment-PAEON', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Model Driven Computation for Infertility Related Endocrinological Diseases - PAEON', 'orgStudyIdInfo': {'id': '17721_PAEON'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal, pathological cycle, infertility', 'description': 'healthy women PCOS Endometriosis hyperprolactinemia fertility treatment', 'interventionNames': ['Other: Fertility treatment']}], 'interventions': [{'name': 'Fertility treatment', 'type': 'OTHER', 'description': 'Fertility treatment', 'armGroupLabels': ['Normal, pathological cycle, infertility']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich, Division of Reproductive Endocrinology', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Brigitte Leeners, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zurich, Division of Reproductive Endocrinology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}