Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-03-04 @ 1:15 PM
Study NCT ID:
NCT01331720
Status:
COMPLETED
Last Update Posted:
2011-04-08
First Post:
2011-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Effectiveness and Tolerability of Ovarian Hyperstimulation
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': 279}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2010-07', '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': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '0-30 days'}], 'secondaryOutcomes': [{'measure': 'Biochemical pregnancy rate', 'timeFrame': '0-16 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['STERILITY']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to assess the effectiveness of 5 mixed protocols of ovarian hyperstimulation with urinary gonadotrophins to achieve clinical pregnancy in females undergoing assisted reproductive techniques (IVF/ICSI) (in-vitro fertilisation/intracytoplasmic sperm injection).\n\nStudy hypothesis: mixed protocols with urinary FSH (follicle-stimulating hormone) and urinary hMG (human menopausal gonadotropin)should be more effective than monotherapy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Females affected by sterility able to undergo IVF/ICSI', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index (BMI) between 18 and 30\n* Prolactin within the laboratory normal range\n* Couples affected by sterility able to treat by IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection)\n* Patients undergoing Menopur® and/or Bravelle® treatment\n* Normal thyroid function\n* Women not receiving clomifen citrate or gonadotrophins within one month prior study start\n* Couples willing to participate in the study that have signed the informed consent form\n\nExclusion Criteria:\n\n* Failure in 3 previous cycles of assisted reproduction IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection)\n* Policystic ovarian syndrome\n* Seminal samples not apt for IVF-ICSI (according to the criteria of each center)\n* Evidence of significant bacterial infection in the seminogram of the couple in the preceding 6 months\n* Antecedents of severe ovarian hyperstimulation syndrome (OHSS)\n* Important systemic disease\n* Pregnancy or contraindication to pregnancy'}, 'identificationModule': {'nctId': 'NCT01331720', 'acronym': 'DESCARTES', 'briefTitle': 'Assessment of the Effectiveness and Tolerability of Ovarian Hyperstimulation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'Assessment of the Effectiveness and Tolerability of Ovarian Hyperstimulation Protocols Which Are the Most Common in Clinical Practice Using High Purified Gonadotrophins (u-FSH-HP y u-hMG-HP) in IVF/ICSI', 'orgStudyIdInfo': {'id': 'FER-MEN-2006-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'FSH:LH 1:1 - Treatment Group A', 'description': 'Patients with a condition\n\nLH (luteinizing hormone)', 'interventionNames': ['Drug: hMG-HP']}, {'label': 'FSH:LH 3:2 - Treatment Group B', 'description': 'Patients with a condition', 'interventionNames': ['Drug: hMG-HP']}, {'label': 'FSH:LH 3:1 - Treatment Group C', 'description': 'Patients with a condition', 'interventionNames': ['Drug: hMG-HP']}, {'label': 'FSH:LH 3:0 - Treatment Group D', 'description': 'Patients with a condition', 'interventionNames': ['Drug: hMG-HP']}, {'label': 'Initially FSH:LH 3:0 and on S6 FSH:LH 1:1 - Treatment Group E', 'description': 'Patients with a condition', 'interventionNames': ['Drug: hMG-HP']}], 'interventions': [{'name': 'hMG-HP', 'type': 'DRUG', 'armGroupLabels': ['FSH:LH 1:1 - Treatment Group A', 'FSH:LH 3:0 - Treatment Group D', 'FSH:LH 3:1 - Treatment Group C', 'FSH:LH 3:2 - Treatment Group B', 'Initially FSH:LH 3:0 and on S6 FSH:LH 1:1 - Treatment Group E']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Albacete', 'state': 'Albacete', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 38.99424, 'lon': -1.85643}}, {'city': 'Alicante', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'city': 'Elche', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 38.26218, 'lon': -0.70107}}, {'city': 'Badajoz', 'state': 'Badajoz', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 38.87789, 'lon': -6.97061}}, {'city': 'Castellon', 'state': 'Castellón', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 39.98567, 'lon': -0.04935}}, {'city': 'Santiago de Compostela', 'state': 'La Coruña', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'city': 'Mallorca', 'state': 'Mallorca', 'country': 'Spain', 'facility': 'Investigational site'}, {'city': 'Murcia', 'state': 'Murcia', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'city': 'Málaga', 'state': 'Málaga', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Navarra', 'state': 'Pamplona', 'country': 'Spain', 'facility': 'Investigational site'}, {'city': 'Gijón', 'state': 'Principality of Asturias', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 43.53573, 'lon': -5.66152}}, {'city': 'Santa Cruz de Tenerife', 'state': 'Tenerife', 'country': 'Spain', 'facility': 'Investigational site Sta. Cruz', 'geoPoint': {'lat': 28.46824, 'lon': -16.25462}}, {'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Zaragoza', 'state': 'Zaragoza', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], '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'}}}}