Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2026-02-22 @ 12:23 PM
Study NCT ID:
NCT03398603
Status:
COMPLETED
Last Update Posted:
2020-01-28
First Post:
2017-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is the Concentration of Anti-Muellerian Hormon (AMH) Depending on the Menstrual Cycle?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'For screening titer of hepatitis B/C- and HIV is measured once\n\nOn every second day of two non-consecutive menstrual cycles we take encoded blood samples and measure the AMH value with the "ElecSys" method as well as the hormons LH, FSH, Estradiol und Progesterone\n\nOn every second day of two non-consecutive menstrual cycles we take an encoded vaginal 3D ultrasound.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-10-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-25', 'studyFirstSubmitDate': '2017-12-26', 'studyFirstSubmitQcDate': '2018-01-07', 'lastUpdatePostDateStruct': {'date': '2020-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'between cycle reliability of ovarian reserve assessment based on AMH serum concentration', 'timeFrame': '3 months', 'description': 'stabile assessment of ovarian reserve with AMH (pmol/l) in blood'}], 'secondaryOutcomes': [{'measure': 'number of ovarian follicles as made visible by 3D ultrasound', 'timeFrame': '3 months', 'description': 'Fluctuations of antral follicle count during different menstrual cycles'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AMH measurement "ElecSys"'], 'conditions': ['Ovarian Failure']}, 'referencesModule': {'references': [{'pmid': '34717057', 'type': 'DERIVED', 'citation': 'Biniasch M, Laubender RP, Hund M, Buck K, De Geyter C. Intra- and inter-cycle variability of anti-Mullerian hormone (AMH) levels in healthy women during non-consecutive menstrual cycles: the BICYCLE study. Clin Chem Lab Med. 2021 Oct 29;60(4):597-605. doi: 10.1515/cclm-2021-0698. Print 2022 Mar 28.'}]}, 'descriptionModule': {'briefSummary': 'The developement of a new, stable measurement of the Antimuellerian Hormon (AMH) together with Roche Diagnostics International (Rotkreuz, CH) shall enable an automized and timely measurement of AMH values in blood samples.', 'detailedDescription': 'An important requirement for the use of the new measurement to determine the AMH concentration is the stability of the AMH level over the menstrual cycle. So far the unbiased AMH concentration is the most important argument to manage this parameter.\n\nThere are several studies, which give different professional opinions of the AMH concentration depending on the phase of the menstrual cycle. Some authors came to the conclusion that the AMH concentration over the menstrual cycle is constant, others described significant fluctuations. It is unclear, if the described fluctuation is relevant for the interpretation of the ovarian reserve. Recently it could be shown, that intraindividual fluctuations of joung women during the menstrual cycle is stronger, which means that the measurement of AMH in this age is less secure.\n\nThe primary goal of the study is to evaluate, if the new AMH measurement with the ElecSys method delivers stable values over the menstrual cycle.\n\nThe secondary goal of the study is to determine whether there are any fluctuations in the number of antral follicles as given by 3D ultrasound.\n\nFor this reason we are recruiting a group of 50 women within two categories of age to measure eventually changes in AMH- concentration during their menstrual cycle.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '50 healthy female probands', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Regular natural menstrual cycle between 24 and 32 days\n* Body Mass Index (BMI) between 19 and 26 kg/m2\n* Negative serum titer for HIV, Hepatitis B and Hepatitis C\n* Non-smoker\n* Willingness to visit the clinic every second day of two non-consecutive menstrual cycles.\n\nExclusion Criteria:\n\n* Intake of hormonal medication like contraceptives\n* Pregnancy/breast feeding\n* Known infertility\n* Known former or actual hormonal disorder\n* Polycystic ovarial syndrom (PCOS)\n* Participation on another clinical trial during the last 3 months.'}, 'identificationModule': {'nctId': 'NCT03398603', 'acronym': 'Bicycle', 'briefTitle': 'Is the Concentration of Anti-Muellerian Hormon (AMH) Depending on the Menstrual Cycle?', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Is the Concentration of Anti-Muellerian Hormon (AMH) Depending on the Menstrual Cycle?', 'orgStudyIdInfo': {'id': '2016-01824'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': '25 women with age of 18-25 years', 'interventionNames': ['Procedure: blood sample and ultrasound']}, {'label': 'Group 2', 'description': '25 women with age of 26-40 years', 'interventionNames': ['Procedure: blood sample and ultrasound']}], 'interventions': [{'name': 'blood sample and ultrasound', 'type': 'PROCEDURE', 'description': 'When included in the study blood samples and ultrasound are taken every second day of the first and third menstrual cycle after inclusion.', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Klinik für Gyn. Endokrinologie und Reproduktionsmedizin der Frauenklinik des Universitätsspitals', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Christian De Geyter, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'USB'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Roche Diagnostic Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Christian De Geyter', 'investigatorAffiliation': 'University Hospital, Basel, Switzerland'}}}}