Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-31 @ 12:46 PM
Study NCT ID:
NCT01331733
Status:
COMPLETED
Last Update Posted:
2011-04-08
First Post:
2011-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Assessment of the Clinical Utility of Ovarian Stimulation With Menotropin Versus Menotropin Plus GnRH Antagonist
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': 131}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-07', 'studyFirstSubmitDate': '2011-04-06', 'studyFirstSubmitQcDate': '2011-04-07', 'lastUpdatePostDateStruct': {'date': '2011-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Live birth rate', 'timeFrame': '40 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sterility']}, 'descriptionModule': {'briefSummary': 'To assess the effectiveness of protocols of ovarian hyperstimulation combining urinary gonadotrophins + GnRH antagonist vs urinary gonadotrophins, to achieve clinical pregnancy in females undergoing intrauterine insemination.\n\nStudy hypothesis: protocols combining urinary gonadotrophins + GnRH antagonist should be more effective than monotherapy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '36 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Females affected by sterility able to undergo intrauterine insemination', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 18-36 years\n* Body mass index (BMI) between 18 and 26\n* Prolactin within the laboratory normal range\n* Couples affected by sterility able to treat by IUI (intrauterine insemination)\n* Patients undergoing Menopur® treatment\n* Normal thyroid function\n* Regular menses (21-35 days)\n* Couples willing to participate in the study that have signed the informed consent form\n* Seminal sample REM\\>3 million\n\nExclusion Criteria:\n\n* Two previous ART (assisted reproductive technology) cycles without ongoing pregnancy\n* Policystic ovarian syndrome\n* Evidence of significant bacterial infection in the seminogram of the couple in the preceding 6 months'}, 'identificationModule': {'nctId': 'NCT01331733', 'acronym': 'PROMENIA', 'briefTitle': 'Comparative Assessment of the Clinical Utility of Ovarian Stimulation With Menotropin Versus Menotropin Plus GnRH Antagonist', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'Comparative Assessment of the Clinical Utility of Ovarian Stimulation With Menotropin Versus Menotropin Plus GnRH Antagonist Following Two Protocols of Ovulation Induction for Intrauterine Insemination', 'orgStudyIdInfo': {'id': 'FER-MEN-2006-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'hMG-HP', 'description': 'Patients with a condition', 'interventionNames': ['Drug: hMG-HP']}, {'label': 'hMG-HP + GnRH antagonist', 'description': 'Patients with a condition', 'interventionNames': ['Drug: hMG + GnRH antagonist']}], 'interventions': [{'name': 'hMG-HP', 'type': 'DRUG', 'armGroupLabels': ['hMG-HP']}, {'name': 'hMG + GnRH antagonist', 'type': 'DRUG', 'armGroupLabels': ['hMG-HP + GnRH antagonist']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Ciudad Real', 'state': 'Ciudad Real', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 38.98626, 'lon': -3.92907}}, {'city': 'Girona', 'state': 'Gerona', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}, {'city': 'La Rioja', 'state': 'La Rioja', 'country': 'Spain', 'facility': 'Investigational site'}, {'city': 'Navarra', 'state': 'Navarre', 'country': 'Spain', 'facility': 'Investigational site'}, {'city': 'Reus', 'state': 'Tarragona', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 41.15612, 'lon': 1.10687}}, {'city': 'Valladolid', 'state': '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'}}}}