Ignite Creation Date:
2025-12-24 @ 2:48 PM
Ignite Modification Date:
2026-03-14 @ 5:47 AM
Study NCT ID:
NCT06330259
Status:
COMPLETED
Last Update Posted:
2024-04-01
First Post:
2024-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does the AMH Concentration Depend on the Menstrual Cycle?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-28', 'studyFirstSubmitDate': '2024-03-19', 'studyFirstSubmitQcDate': '2024-03-19', 'lastUpdatePostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AMH Elecsys Assay', 'timeFrame': '3 months', 'description': 'The anti-Muellerian Hormone (AMH) is a heterodimer. As such, it is unstable. The newly developed assay is considered to account for this inherent instability of the hormone and is thought to produce more consistent results.'}], 'secondaryOutcomes': [{'measure': 'Effect of handling of the serum on measured AMH concentrations', 'timeFrame': '3 months', 'description': 'Handling of the serum samples may impact measured levels. The serum levels will be measured as part of daily routine both on the day of the sampling and in frozen samples (in batches, under maximal care conditions) the stability of observed serum values during the menstrual cycle'}, {'measure': '3D ultrasound of both ovaries', 'timeFrame': '3 months', 'description': 'Fluctuations in the number of antral follicles during the menstrual cycle.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['natural menstrual cycle', 'AMH', '3D ultrasound'], 'conditions': ['Reproductive Sterility']}, 'descriptionModule': {'briefSummary': 'During two none subsequent natural menstrual cycles healthy female participants will be subjected every second day to blood sampling and 3D-ultrasound examinations. Together with four other key hormones the concentration of AMH (anti-Muellerian Hormone) will be measured in the serum.', 'detailedDescription': 'During two none subsequent natural menstrual cycles healthy female participants will be subjected every second day to blood sampling and 3D-ultrasound examinations. Together with four other key hormones the concentration of AMH will be measured in the serum. Half of the serum samples will immediately be subjected to hormone analysis whereas the other half will be stored frozen at -80 °C. After conclusion of the study the frozen samples will be subjected to re-measurment again a reference laboratory. The aim is to study the stability of the AMH Elecsys Assay under both conditions. The participants will be health women aged between 18 and 40 years. They will be grouped into a younger and an older group. They will be observed during one menstrual cycle, then they will remain unobserved during a second menstrual cycle, and then again they will be observed during a third menstrual cycle.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'healthy female women with regular menstrual cycles.', 'genderDescription': 'Only women are recruited.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* regular menstrual cycles, between 24 and 32 d.\n* body mass index between 24 and 32 kg/m2\n* no HIV, no Hepatitis B and C\n* no smoking\n\nExclusion Criteria:\n\n* intake of reproductive hormones, including birth control pill\n* pregnancy or breastfeeding\n* infertility\n* polycystic ovary syndrome'}, 'identificationModule': {'nctId': 'NCT06330259', 'acronym': 'AMH', 'briefTitle': 'Does the AMH Concentration Depend on the Menstrual Cycle?', 'organization': {'class': 'OTHER', 'fullName': 'University of Basel'}, 'officialTitle': 'Ist Die Konzentration Des Anti-Müllerschen Hormons (AMH) abhängig Vom Menstruationszyklus?', 'orgStudyIdInfo': {'id': 'new AMH assay'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A', 'description': '25 younger women, aged 18 to 25 y.', 'interventionNames': ['Diagnostic Test: menstrual cycle monitoring']}, {'label': 'Group B', 'description': '25 less young women, aged 26 to 39 y.', 'interventionNames': ['Diagnostic Test: menstrual cycle monitoring']}], 'interventions': [{'name': 'menstrual cycle monitoring', 'type': 'DIAGNOSTIC_TEST', 'description': 'frequent serum sampling and 3D ultrasound', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Christian De Geyter', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Christian De Geyter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Basel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Basel', 'class': 'OTHER'}, 'collaborators': [{'name': 'Roche Diagnostics GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Christian De Geyter', 'investigatorAffiliation': 'University of Basel'}}}}