Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-03-09 @ 8:30 AM
Study NCT ID:
NCT02935335
Status:
COMPLETED
Last Update Posted:
2019-03-05
First Post:
2016-10-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Measure Relationship Between Antimüllerian Hormone and Initial Dose of Menopur®
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008596', 'term': 'Menotropins'}], 'ancestors': [{'id': 'D006065', 'term': 'Gonadotropins, Pituitary'}, {'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 297}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-04', 'studyFirstSubmitDate': '2016-10-14', 'studyFirstSubmitQcDate': '2016-10-14', 'lastUpdatePostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spearman correlation coefficient between Menopur® 600 IU/mL dose and AMH serum levels', 'timeFrame': 'At baseline (inclusion)'}]}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'AME is a non-interventional, prospective, longitudinal and multicenter study. This study aims to measure the relationship between antimüllerian hormone serum level (AMH), as measured by a fully automated assay and the initial dose of Menopur® HP-hMG 600 IU/mL prescribed for infertile women undergoing their first IVF/ICSI cycle in the current practice.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Specialized fertility centers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged between \\[18-42\\] years.\n* Both ovaries present.\n* Regular menstrual cycles presumed to be ovulatory.\n* Primary or secondary infertility of any origin for more than 12 months.\n* Patient with at least one result of antimüllerian hormone (AMH) measured by a fully automated assay available before inclusion, and performed in the past 12 months before inclusion.\n* Candidates eligible to a first IVF/ICSI cycle and for whom Menopur® HP-hMG 600 IU/mL has been prescribed.\n* Having received oral and written information on the study, without any objections for the use of his/her anonymized data, and having signed a written Informed Consent Form.\n\nExclusion Criteria:\n\n* Major uterine or ovarian morphological abnormalities or past ovarian surgery.\n* Endometriosis stage III/IV.\n* Polycystic ovarian syndrome.\n* Major endocrine or metabolic abnormalities without treatment.\n* Patient included in an interventional study assessing treatment for infertility.'}, 'identificationModule': {'nctId': 'NCT02935335', 'acronym': 'AME', 'briefTitle': 'A Study to Measure Relationship Between Antimüllerian Hormone and Initial Dose of Menopur®', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'Relationship Between antimüllerian Hormone Measured by a Fully Automated Assay and the Initial Dose of HP-hMG (Menopur®) Prescribed for Infertile Women Undergoing Their First IVF/ICSI Cycle.', 'orgStudyIdInfo': {'id': '000237'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Menopur® HP-hMG', 'description': 'Treatment according to routine clinical practice.', 'interventionNames': ['Drug: Menotrophin']}], 'interventions': [{'name': 'Menotrophin', 'type': 'DRUG', 'otherNames': ['Menopur® HP-hMG'], 'armGroupLabels': ['Menopur® HP-hMG']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Suresnes', 'country': 'France', 'facility': 'Hospital FOCH (there may be other sites in this country)', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}], 'overallOfficials': [{'name': 'Clinical Development Support', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ferring Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ferring Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}