Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-27 @ 11:17 PM
Study NCT ID:
NCT01354834
Status:
COMPLETED
Last Update Posted:
2025-03-28
First Post:
2011-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Effectiveness of Menopur in Intrauterine Insemination
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 207}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-27', 'studyFirstSubmitDate': '2011-05-16', 'studyFirstSubmitQcDate': '2011-05-16', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Live birth rate', 'timeFrame': '40 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effectiveness of Menopur to achieve clinical pregnancy in females undergoing intrauterine insemination in clinical practice.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Females affected by infertility able to undergo intrauterine insemination', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infertile couples for over one year (primary or secondary) or infertile women (or not) with indication of PAI or DAI\n* Seminal sample suitable for artificial insemination treatment according to the criterion of each centre\n* Patient prescribed therapy with Menopur in artificial insemination\n\nExclusion Criteria:\n\n* Contraindications to intrauterine insemination\n* Contraindications to Menopur'}, 'identificationModule': {'nctId': 'NCT01354834', 'briefTitle': 'Assessment of the Effectiveness of Menopur in Intrauterine Insemination', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'Assessment of the Clinical Efficacy of Menopur® in Intrauterine Artificial Insemination (From Partner or From Donor)', 'orgStudyIdInfo': {'id': 'FER-MEN-2003-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'hMG', 'interventionNames': ['Drug: hMG']}], 'interventions': [{'name': 'hMG', 'type': 'DRUG', 'description': 'Patients with a condition', 'armGroupLabels': ['hMG']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Elche', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 38.26218, 'lon': -0.70107}}, {'city': 'Las Palmas', 'state': 'Grand Canaria', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 28.58232, 'lon': -16.16555}}, {'city': 'Santiago', 'state': 'La Coruña', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 37.9358, 'lon': -4.13866}}, {'city': 'Reus', 'state': 'Tarragona', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 41.15612, 'lon': 1.10687}}, {'city': 'Albacete', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 38.99424, 'lon': -1.85643}}, {'city': 'Alicante', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'city': 'Almería', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 36.83814, 'lon': -2.45974}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Burgos', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 42.34106, 'lon': -3.70184}}, {'city': 'León', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 42.60003, 'lon': -5.57032}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Seville', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Toldeo', 'country': 'Spain', 'facility': 'Investigational site'}, {'city': 'Valladolid', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}], 'overallOfficials': [{'name': 'Clinical Development Support', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ferring Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ferring Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Ferring SAU', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Clinical Development Support', 'oldOrganization': 'Ferring Pharmaceuticals'}}}}