Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2026-01-04 @ 4:16 PM
Study NCT ID:
NCT00415766
Status:
UNKNOWN
Last Update Posted:
2016-01-20
First Post:
2006-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Recombinant Versus Urinary hCG for Ovulation Induction in High Responders
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006063', 'term': 'Chorionic Gonadotropin'}], 'ancestors': [{'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010926', 'term': 'Placental Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011257', 'term': 'Pregnancy Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-01-18', 'studyFirstSubmitDate': '2006-12-22', 'studyFirstSubmitQcDate': '2006-12-23', 'lastUpdatePostDateStruct': {'date': '2016-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of mature oocytes', 'timeFrame': 'Day of oocyte retrieval (Day 0)', 'description': 'Percentage MII/COCs'}], 'secondaryOutcomes': [{'measure': 'Positive test per embryo transfer', 'timeFrame': '15 days post oocyte retrieval'}, {'measure': 'Clinical pregnancy per embryo transfer', 'timeFrame': '7 weeks of gestation'}, {'measure': 'Ongoing pregnancy per embryo transfer', 'timeFrame': '12 weeks of gestation'}, {'measure': 'Level of serum hCG on day of oocyte retrieval', 'timeFrame': 'Day of oocyte retrieval'}, {'measure': 'Number of oocytes (COC) retrieved', 'timeFrame': 'Day of oocyte retrieval'}, {'measure': 'Number of mature oocytes (MII)', 'timeFrame': 'Day of oocyte retrieval'}, {'measure': 'Oocyte retrieval rate', 'timeFrame': 'Day of oocyte retrieval (Day 0)', 'description': 'Number of oocytes retrieved/number of follicles on the day of triggering final oocyte maturation'}, {'measure': 'Incidence of severe early OHSS', 'timeFrame': 'up to Day 5 post oocyte retrieval'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['recombinant hCG', 'urinary hCG'], 'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '16848893', 'type': 'BACKGROUND', 'citation': 'Revelli A, Poso F, Gennarelli G, Moffa F, Grassi G, Massobrio M. Recombinant versus highly-purified, urinary follicle-stimulating hormone (r-FSH vs. HP-uFSH) in ovulation induction: a prospective, randomized study with cost-minimization analysis. Reprod Biol Endocrinol. 2006 Jul 18;4:38. doi: 10.1186/1477-7827-4-38.'}, {'pmid': '15846677', 'type': 'BACKGROUND', 'citation': 'Al-Inany HG, Aboulghar M, Mansour R, Proctor M. Recombinant versus urinary human chorionic gonadotrophin for ovulation induction in assisted conception. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD003719. doi: 10.1002/14651858.CD003719.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the clinical outcomes of recombinant human chorionic gonadotrophin (rHCG) and urinary HCG (uHCG) in patients undergoing IVF cycles.', 'detailedDescription': 'Urinary human chorionic gonadotrophin (u-hCG) has been widely used to induce final oocyte maturation and to trigger ovulation in assisted conception. Recombinant technology has allowed the production of r-hCG inj which all urinary contaminants are absent. Hence, this would allow the safe subcutaneous administration of a compound with less batch-to-batch variation. This study will investigate the effectiveness of the recombinant hCG compared to the currently used urinary hCG.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 14 follicles \\>11mm on the day of triggering final oocyte maturation\n* Pretreated with GnRH antagonist protocol\n\nExclusion Criteria:\n\n* Poor responders\n* Women with 25 or more follicles on the day of trigger'}, 'identificationModule': {'nctId': 'NCT00415766', 'briefTitle': 'Comparison Between Recombinant Versus Urinary hCG for Ovulation Induction in High Responders', 'organization': {'class': 'OTHER', 'fullName': 'Eugonia'}, 'officialTitle': 'Recombinant hCG (Ovitrelle) Vesrus Urinary hCG (Pregnyl) for Triggering Final Oocyte Maturation in High Responders', 'orgStudyIdInfo': {'id': 'ovitrelle vs pregnyl'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'rHCG 250 ug', 'description': 'Injection of 250 ug Ovitrelle to trigger final oocyte maturation', 'interventionNames': ['Drug: rHCG 250ug']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'uHCG 5000 IU', 'description': 'Injection of 5000 IU Pregnyl to trigger final oocyte maturation', 'interventionNames': ['Drug: uHCG 5000 IU']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'uHCG 7500 IU', 'description': 'Injection of 7500 IU Pregnyl to trigger final oocyte maturation', 'interventionNames': ['Drug: uHCG 7500 IU']}], 'interventions': [{'name': 'rHCG 250ug', 'type': 'DRUG', 'otherNames': ['Ovitrelle'], 'description': 'Injection of 250 ug Ovitrelle to trigger final oocyte maturation', 'armGroupLabels': ['rHCG 250 ug']}, {'name': 'uHCG 5000 IU', 'type': 'DRUG', 'otherNames': ['Pregnyl 5000 IU'], 'description': 'Injection of 5000 IU Pregnyl to trigger final oocyte maturation', 'armGroupLabels': ['uHCG 5000 IU']}, {'name': 'uHCG 7500 IU', 'type': 'DRUG', 'otherNames': ['Pregnyl 7500 IU'], 'description': 'Injection of 7500 IU Pregnyl to trigger final oocyte maturation', 'armGroupLabels': ['uHCG 7500 IU']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11528', 'city': 'Athens', 'country': 'Greece', 'facility': 'Eugonia', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'overallOfficials': [{'name': 'Tryfon Lainas, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eugonia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eugonia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}