Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-31 @ 10:30 PM
Study NCT ID:
NCT00627406
Status:
COMPLETED
Last Update Posted:
2013-11-27
First Post:
2008-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Triggering of Final Oocyte Maturation With GnRHa (Buserelin) in GnRH Antagonist Cycles
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016471', 'term': 'Ovarian Hyperstimulation Syndrome'}], 'ancestors': [{'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002064', 'term': 'Buserelin'}, {'id': 'D006063', 'term': 'Chorionic Gonadotropin'}], 'ancestors': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D010926', 'term': 'Placental Hormones'}, {'id': 'D011257', 'term': 'Pregnancy Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'peter.humaidan@viborg.rm.dk', 'phone': '+45 78 44 57 60', 'title': 'Dr. Peter Humaidan', 'organization': 'Fertility Clinic Regional Hospital Skive'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'A: >14 Follicles; GnRHa Trigger + 1500 hCG', 'description': 'More than 14 follicles with a diameter of \\> 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)\n\nBuserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU', 'otherNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'B: >14 Follicles; hCG Trigger', 'description': 'More than 14 follicles with a diameter of \\> 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)\n\nPregnyl : Subcutaneous injection 5000 IU', 'otherNumAtRisk': 58, 'otherNumAffected': 0, 'seriousNumAtRisk': 58, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2', 'description': '14 or less follicles with a diameter of \\> 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5)\n\nBuserelin and Pregnyl : Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days', 'otherNumAtRisk': 125, 'otherNumAffected': 0, 'seriousNumAtRisk': 125, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'D: <15 Follicles; hCG Trigger', 'description': '14 or less follicles with a diameter of \\> 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)\n\nPregnyl : Subcutaneous injection 5000 IU', 'otherNumAtRisk': 141, 'otherNumAffected': 0, 'seriousNumAtRisk': 141, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Frequency of Moderate to Severe OHSS.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '141', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'A: >14 Follicles; GnRHa Trigger + 1500 hCG', 'description': 'More than 14 follicles with a diameter of \\> 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)\n\nBuserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU'}, {'id': 'OG001', 'title': 'B: >14 Follicles; hCG Trigger', 'description': 'More than 14 follicles with a diameter of \\> 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)\n\nPregnyl : Subcutaneous injection 5000 IU'}, {'id': 'OG002', 'title': 'C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2', 'description': '14 or less follicles with a diameter of \\> 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5)\n\nBuserelin and Pregnyl : Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days'}, {'id': 'OG003', 'title': 'D: <15 Follicles; hCG Trigger', 'description': '14 or less follicles with a diameter of \\> 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)\n\nPregnyl : Subcutaneous injection 5000 IU'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of triggering ovulation until 2 weeks after pregnancy test. group C and D. 12 days after pregnancy test', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'No power calculation was proformed.'}, {'type': 'SECONDARY', 'title': 'Pregnancy Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '141', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'A: >14 Follicles; GnRHa Trigger + 1500 hCG', 'description': 'More than 14 follicles with a diameter of \\> 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)\n\nBuserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU'}, {'id': 'OG001', 'title': 'B: >14 Follicles; hCG Trigger', 'description': 'More than 14 follicles with a diameter of \\> 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)\n\nPregnyl : Subcutaneous injection 5000 IU'}, {'id': 'OG002', 'title': 'C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2', 'description': '14 or less follicles with a diameter of \\> 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5)\n\nBuserelin and Pregnyl : Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days'}, {'id': 'OG003', 'title': 'D: <15 Follicles; hCG Trigger', 'description': '14 or less follicles with a diameter of \\> 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)\n\nPregnyl : Subcutaneous injection 5000 IU'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from stimulation day 1 until last ultrasound scan 7 weeks after a positive pregnancy test', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'A: >14 Follicles; GnRHa Trigger + 1500 hCG', 'description': 'More than 14 follicles with a diameter of \\> 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)\n\nBuserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU'}, {'id': 'FG001', 'title': 'B: >14 Follicles; hCG Trigger', 'description': 'More than 14 follicles with a diameter of \\> 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)\n\nPregnyl : Subcutaneous injection 5000 IU'}, {'id': 'FG002', 'title': 'C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2', 'description': '14 or less follicles with a diameter of \\> 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5)\n\nBuserelin and Pregnyl : Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days'}, {'id': 'FG003', 'title': 'D: <15 Follicles; hCG Trigger', 'description': '14 or less follicles with a diameter of \\> 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)\n\nPregnyl : Subcutaneous injection 5000 IU'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '125'}, {'groupId': 'FG003', 'numSubjects': '141'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '125'}, {'groupId': 'FG003', 'numSubjects': '141'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment period from jan. 2009 to dec. 2011. Participanting Clinics Fertility clinic Regional Hospital Skive, University Hostipal Odense, Regional Hospital Holbaek, Denmark.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}, {'value': '384', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'A: >14 Follicles; GnRHa Trigger + 1500 hCG', 'description': 'More than 14 follicles with a diameter of \\> 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)\n\nBuserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU'}, {'id': 'BG001', 'title': 'B: >14 Follicles; hCG Trigger', 'description': 'More than 14 follicles with a diameter of \\> 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)\n\nPregnyl : Subcutaneous injection 5000 IU'}, {'id': 'BG002', 'title': 'C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2', 'description': '14 or less follicles with a diameter of \\> 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5)\n\nBuserelin and Pregnyl : Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days'}, {'id': 'BG003', 'title': 'D: <15 Follicles; hCG Trigger', 'description': '14 or less follicles with a diameter of \\> 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)\n\nPregnyl : Subcutaneous injection 5000 IU'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}, {'value': '384', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.5', 'spread': '5.2', 'groupId': 'BG000'}, {'value': '29.8', 'spread': '3.8', 'groupId': 'BG001'}, {'value': '30.8', 'spread': '3.9', 'groupId': 'BG002'}, {'value': '31.5', 'spread': '3.7', 'groupId': 'BG003'}, {'value': '30.2', 'spread': '4.0', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}, {'value': '384', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Denmark', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}, {'value': '384', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 384}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-25', 'studyFirstSubmitDate': '2008-02-22', 'resultsFirstSubmitDate': '2013-09-25', 'studyFirstSubmitQcDate': '2008-02-29', 'lastUpdatePostDateStruct': {'date': '2013-11-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-09-25', 'studyFirstPostDateStruct': {'date': '2008-03-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of Moderate to Severe OHSS.', 'timeFrame': 'From the date of triggering ovulation until 2 weeks after pregnancy test. group C and D. 12 days after pregnancy test'}], 'secondaryOutcomes': [{'measure': 'Pregnancy Rate', 'timeFrame': 'from stimulation day 1 until last ultrasound scan 7 weeks after a positive pregnancy test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GnRH antagonist', 'GnRH agonist', 'hCG', 'OHSS', 'In vitro fertilization', 'ovulation induction', 'Clinical pregnancy rate'], 'conditions': ['OHSS (Ovarian Hyperstimulation)']}, 'referencesModule': {'references': [{'pmid': '23753114', 'type': 'DERIVED', 'citation': 'Humaidan P, Polyzos NP, Alsbjerg B, Erb K, Mikkelsen AL, Elbaek HO, Papanikolaou EG, Andersen CY. GnRHa trigger and individualized luteal phase hCG support according to ovarian response to stimulation: two prospective randomized controlled multi-centre studies in IVF patients. Hum Reprod. 2013 Sep;28(9):2511-21. doi: 10.1093/humrep/det249. Epub 2013 Jun 9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to possibly further improve the clinical outcome and explore the incidence of OHSS in patients, who have final oocyte maturation with GnRHa (Buserelin) in GnRH antagonist IVF/ICSI cycles'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient complying with the conditions for IVF or ICSI treatment\n* Female age over 20 years and under 40 years\n* Normal regular cycle and patients with oligomenorrhea\n* BMI \\> 18 and \\< 35\n* each patient contributes with one cycle only\n\nExclusion Criteria:\n\n* Significant disturbances in the woman (diabetes, epilepsy, liver/renal/heart disease, metabolic disorder)\n* Patients with \\> 25 follicles on the day of triggering ovulation'}, 'identificationModule': {'nctId': 'NCT00627406', 'briefTitle': 'Triggering of Final Oocyte Maturation With GnRHa (Buserelin) in GnRH Antagonist Cycles', 'organization': {'class': 'OTHER', 'fullName': 'Regionshospitalet Viborg, Skive'}, 'officialTitle': 'A Prospective Randomised Study to Evaluate the Effect of Triggering Ovulation With GnRHa (Buserelin) and Low Dose hCG (Pregnyl) as Compared to the Use of Conventional Doses of hCG (Pregnyl)', 'orgStudyIdInfo': {'id': 'N-VN-2002-0046MCH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'More than 14 follicles with a diameter of \\> 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)', 'interventionNames': ['Drug: Buserelin and Pregnyl']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'More than 14 follicles with a diameter of \\> 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)', 'interventionNames': ['Drug: Pregnyl']}, {'type': 'EXPERIMENTAL', 'label': 'C', 'description': '14 or less follicles with a diameter of \\> 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5)', 'interventionNames': ['Drug: Buserelin and Pregnyl']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'D', 'description': '14 or less follicles with a diameter of \\> 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)', 'interventionNames': ['Drug: Pregnyl']}], 'interventions': [{'name': 'Buserelin and Pregnyl', 'type': 'DRUG', 'description': 'Subcutaneous injection 0.5 mg and 1500 IU', 'armGroupLabels': ['A']}, {'name': 'Pregnyl', 'type': 'DRUG', 'description': 'Subcutaneous injection 5000 IU', 'armGroupLabels': ['B']}, {'name': 'Buserelin and Pregnyl', 'type': 'DRUG', 'description': 'Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days', 'armGroupLabels': ['C']}, {'name': 'Pregnyl', 'type': 'DRUG', 'description': 'Subcutaneous injection 5000 IU', 'armGroupLabels': ['D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7800', 'city': 'Skive', 'country': 'Denmark', 'facility': 'The Fertility Clinic, Regional Hospital of Skive', 'geoPoint': {'lat': 56.56699, 'lon': 9.02707}}], 'overallOfficials': [{'name': 'Peter S Humaidan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regionshospitalet Viborg, Skive', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. M.D. D.M.Sc.', 'investigatorFullName': 'Peter Humaidan', 'investigatorAffiliation': 'Regionshospitalet Viborg, Skive'}}}}