Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-01-09 @ 12:13 AM
Study NCT ID:
NCT01100333
Status:
COMPLETED
Last Update Posted:
2014-07-31
First Post:
2010-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GONAL-f CONSORT (Consistency in r-hFSH Starting Doses for Individualised Treatment)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}, {'id': 'D006379', 'term': 'Helping Behavior'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015292', 'term': 'Glycoprotein Hormones, alpha Subunit'}, {'id': 'C571801', 'term': 'follitropin alfa'}], 'ancestors': [{'id': 'D006063', 'term': 'Chorionic Gonadotropin'}, {'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D005640', 'term': 'Follicle Stimulating Hormone'}, {'id': 'D006065', 'term': 'Gonadotropins, Pituitary'}, {'id': 'D007986', 'term': 'Luteinizing Hormone'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D013972', 'term': 'Thyrotropin'}, {'id': 'D010926', 'term': 'Placental Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Whole Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2552}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-30', 'studyFirstSubmitDate': '2010-02-24', 'studyFirstSubmitQcDate': '2010-04-07', 'lastUpdatePostDateStruct': {'date': '2014-07-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Consistency of dose of Gonal-f recommended by the doctor for the first stimulation day with the dose recommended by the CONSORT calculator', 'timeFrame': '6 month'}], 'secondaryOutcomes': [{'measure': 'Efficacy parameters', 'timeFrame': '6 month', 'description': 'Total dose and the necessity of a dose adjustment during stimulation period, number of the obtained ova after hCG administration, the duration of the stimulation,stimulation dose on the last stimulation day'}]}, 'conditionsModule': {'keywords': ['Infertility', 'Reproductive technologies, Assisted', 'r-hFSH', 'Gonal-f'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'This non-interventional study (NIS) is planned to examine the consistency of the dose recommended by the doctor for the first stimulation day with the dose recommended by the CONSORT calculator.', 'detailedDescription': 'Since the introduction of the first recombinant human follicle stimulating hormone (FSH) preparation Gonal-f in the year 1996, a pure drug is available as raw material, which is independent of human urine due to biotechnological methods and consequently can be produced free of contaminating proteins. In accordance with the recommendations of European Medicines Agency (EMEA) in February 1999, on the basis of data from clinical studies, Gonal-f should be regarded as the more effective preparation in comparison to urinary FSH. Serono has developed a dose calculator, the CONSORT calculator, after analyzing the data from clinical studies for Gonal-f. This non-interventional study is planned to examine the consistency of the dose recommended by the doctor for the first stimulation day with the dose recommended by the CONSORT calculator. All subjects, who undergo stimulation with Gonal-f in preparation for a technology of the assisted conception in accordance with the permitted indication, will be included in this non-interventional study.\n\nOBJECTIVES\n\nPrimary Objective:\n\n* To examine, how far the dose recommended by the doctor for the first stimulation day varies from the dose recommended by the CONSORT calculator'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects undergoing Assisted Reproductive Technologies (ART) receiving Gonal-f in Germany', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female subjects undergoing stimulation with Gonal-f in ART in accordance with the permitted indication\n* Subjects below 35 years of age\n* Subjects who have a Body mass index below 30\n* Subjects with a basal FSH below 12 I.E./l and is downregulated in the long gonadotropin hormone releasing hormone agonist (GnRHa) Protocol'}, 'identificationModule': {'nctId': 'NCT01100333', 'briefTitle': 'GONAL-f CONSORT (Consistency in r-hFSH Starting Doses for Individualised Treatment)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck KGaA, Darmstadt, Germany'}, 'officialTitle': 'Observational Study GONAL-f® Consort', 'orgStudyIdInfo': {'id': '700623-500'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Recombinant human follicle stimulating hormone (r-hFSH)', 'type': 'DRUG', 'otherNames': ['Gonal-f'], 'description': "Recombinant hFSH prescribed according to prescriber's judgement"}]}, 'contactsLocationsModule': {'locations': [{'zip': '101107', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Universitätsmedizin Charitè Berlin, Schumann Straße 20/21', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'W. Bilger', 'role': 'STUDY_CHAIR', 'affiliation': 'Merck Serono GmbH, Germany, an affiliate of Merck KGaA, Darmstadt, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}