Ignite Creation Date:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2026-01-01 @ 10:49 PM
Study NCT ID:
NCT01785095
Status:
COMPLETED
Last Update Posted:
2017-02-09
First Post:
2013-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Immunogenicity of Repeated Follicle Stimulating Hormone (FSH) Stimulation Cycles
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D043373', 'term': 'Follicle Stimulating Hormone, Human'}], 'ancestors': [{'id': 'D005640', 'term': 'Follicle Stimulating Hormone'}, {'id': 'D006065', 'term': 'Gonadotropins, Pituitary'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rd@ibsa.com', 'phone': '+41583601000', 'title': 'IBSA Clinical Research Manager', 'organization': 'IBSA Institut Biochimique SA'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Follicle Stimulating Hormone', 'otherNumAtRisk': 27, 'otherNumAffected': 7, 'seriousNumAtRisk': 27, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Pirexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'bacterial vaginosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'candida infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'lymp injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Muscle spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Headhache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders'}], 'seriousEvents': [{'term': 'Haemorrhage', 'notes': 'post oocyte retrieval haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients Producing Anti-FSH Antibodies.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Follicle Stimulationg Hormone'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 months.', 'description': 'The immunogenicity potential of FSH in healthy volunteer will be assessed by analysing serum samples collected at different timepoints during two treatment cycle for oocytes donation: cycle 1, serum samples will be collected before treatment start (baseline), after 7-13 days and after 28 days of treatment; Cycle 2: serum samples will be collected before starting the second cycle (baseline 2), after 7-13 days and after 28 days of treatment. Cycle 1 and cycle 2 will be separated by a wash-out period of two months.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'presence of Antibodies against FSH'}, {'type': 'SECONDARY', 'title': 'Number of Oocytes Retrieved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'First Cycle', 'description': 'First treatment cycle.'}, {'id': 'OG001', 'title': 'Second Cycle', 'description': 'Second treatment cycle performed after 1 month of wash out.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.4', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '15.7', 'spread': '7.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after 2 weeks of treatment', 'description': 'the number of oocytes retrieved in the first cycle and in the second cycle are compared.', 'unitOfMeasure': 'oocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Dose of FSH Units Used.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'First Cycle', 'description': 'First treatment cycle.'}, {'id': 'OG001', 'title': 'Second Cycle', 'description': 'Second treatment cycle after 1 month of wash out.'}], 'classes': [{'categories': [{'measurements': [{'value': '1911.1', 'spread': '604.8', 'groupId': 'OG000'}, {'value': '1984.4', 'spread': '622.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after 2 weeks of treatment', 'unitOfMeasure': 'IU', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Follicle Stimulation Hormone', 'description': 'FSH (Follicle stimulation hormone, 75 IU/vial) will be administered to women according to their need and response assessed by the Investigator.\n\nFSH (Follicle Stimulating Hormone)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Follicle Stimulating Hormone'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.7', 'spread': '5.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI (kg/m2)', 'classes': [{'categories': [{'measurements': [{'value': '21.7', 'spread': '2.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All the subjects that started the stimulation.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-19', 'studyFirstSubmitDate': '2013-01-23', 'resultsFirstSubmitDate': '2015-02-12', 'studyFirstSubmitQcDate': '2013-02-04', 'lastUpdatePostDateStruct': {'date': '2017-02-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-03-23', 'studyFirstPostDateStruct': {'date': '2013-02-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients Producing Anti-FSH Antibodies.', 'timeFrame': '4 months.', 'description': 'The immunogenicity potential of FSH in healthy volunteer will be assessed by analysing serum samples collected at different timepoints during two treatment cycle for oocytes donation: cycle 1, serum samples will be collected before treatment start (baseline), after 7-13 days and after 28 days of treatment; Cycle 2: serum samples will be collected before starting the second cycle (baseline 2), after 7-13 days and after 28 days of treatment. Cycle 1 and cycle 2 will be separated by a wash-out period of two months.'}], 'secondaryOutcomes': [{'measure': 'Number of Oocytes Retrieved', 'timeFrame': 'after 2 weeks of treatment', 'description': 'the number of oocytes retrieved in the first cycle and in the second cycle are compared.'}, {'measure': 'Total Dose of FSH Units Used.', 'timeFrame': 'after 2 weeks of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Oocyte Donation']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate immunogenic potential of FSH-IBSA in healthy volunteers undergoing controlled ovarian hyperstimulation (COH) in an oocyte donation program.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy female volunteers undergoing controlled ovarian hyperstimulation for oocyte donation with the following characteristics:\n* Able and willing to sign the Subject Consent Form and adhere to the study visit schedule;\n* \\>=18 and \\<35 years old;\n* Regular menstrual cycle (26 - 35 days);\n* BMI between 18 and 30 kg/m2;\n* First gonadotrophin treatment (i.e. naïve Subjects with regard to exposure to human derived or recombinant gonadotrophins);\n* basal FSH \\<10 IU/L and E2 \\<80 pg/ml (\\~290 pmol/l);\n* Normal TSH levels;\n* Willing to perform at least two consecutive oocyte retrieval cycles (with a wash out period of two months).\n\nExclusion Criteria:\n\n* Age \\<18 and \\>=35 years;\n* PCOS;\n* Endometriosis;\n* Subjects with evidences of autoimmune or rheumatic diseases;\n* Hypersensitivity to the active substance or to any of the excipients (lactose);\n* Abnormal bleeding of undetermined origin;\n* Subject found to be positive to anti-TSH antibodies (i.e. suffering from thyroidal diseases);\n* Uncontrolled adrenal dysfunction;\n* Neoplasia;\n* Severe impairment of renal and/or hepatic function;\n* Use of concomitant medications that might interfere with study evaluations (e.g. immunosuppressant, non-study hormonal medications, therapeutics proteins like insulin, growth hormone…).'}, 'identificationModule': {'nctId': 'NCT01785095', 'briefTitle': 'Immunogenicity of Repeated Follicle Stimulating Hormone (FSH) Stimulation Cycles', 'organization': {'class': 'INDUSTRY', 'fullName': 'IBSA Institut Biochimique SA'}, 'officialTitle': 'Prospective, Open-label, Uncontrolled Clinical Trial Evaluating Multiple Controlled Ovarian Hyperstimulation Cycles in Oocyte Donor, to Assess the Immunogenicity of FSH-IBSA', 'orgStudyIdInfo': {'id': '11E/FSH03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FSH', 'description': 'FSH (Follicle stimulation hormone, 75 IU/vial) will be administered to women according to their need and response assessed by the Investigator.', 'interventionNames': ['Drug: FSH (Follicle Stimulating Hormone)']}], 'interventions': [{'name': 'FSH (Follicle Stimulating Hormone)', 'type': 'DRUG', 'armGroupLabels': ['FSH']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8028', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Dep.Obstet-Gynec.-Reproduction,Institut Universitari Dexeus', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IBSA Institut Biochimique SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}