Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2026-02-24 @ 2:30 PM
Study NCT ID:
NCT00553293
Status:
COMPLETED
Last Update Posted:
2007-11-05
First Post:
2007-11-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nordic Luveris Study
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': 'D007986', 'term': 'Luteinizing Hormone'}, {'id': 'D037101', 'term': 'Luteinizing Hormone, beta Subunit'}, {'id': 'D015292', 'term': 'Glycoprotein Hormones, alpha Subunit'}, {'id': 'C571801', 'term': 'follitropin alfa'}], 'ancestors': [{'id': 'D006065', 'term': 'Gonadotropins, Pituitary'}, {'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D006063', 'term': 'Chorionic Gonadotropin'}, {'id': 'D005640', 'term': 'Follicle Stimulating Hormone'}, {'id': 'D013972', 'term': 'Thyrotropin'}, {'id': 'D010926', 'term': 'Placental Hormones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 526}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2004-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-11-02', 'studyFirstSubmitDate': '2007-11-02', 'studyFirstSubmitQcDate': '2007-11-02', 'lastUpdatePostDateStruct': {'date': '2007-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ongoing pregnancy rate per started stimulation cycle', 'timeFrame': 'ultrasound showing ongoing pregnancy'}], 'secondaryOutcomes': [{'measure': 'Ongoing pregnancy in subgroups of patients with lo0w serum LH levels', 'timeFrame': 'ultrasound for ongoing pregnancy in subgroups'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['infertility', 'in vitro fertilization', 'LH supplementation', 'Benefits'], 'conditions': ['Infertility', 'In Vitro Fertilization']}, 'referencesModule': {'references': [{'pmid': '18024487', 'type': 'DERIVED', 'citation': 'NyboeAndersen A, Humaidan P, Fried G, Hausken J, Antila L, Bangsboll S, Rasmussen PE, Lindenberg S, Bredkjaer HE, Meinertz H; Nordic LH study group. Recombinant LH supplementation to recombinant FSH during the final days of controlled ovarian stimulation for in vitro fertilization. A multicentre, prospective, randomized, controlled trial. Hum Reprod. 2008 Feb;23(2):427-34. doi: 10.1093/humrep/dem317. Epub 2007 Nov 16.'}]}, 'descriptionModule': {'briefSummary': 'To study whether addition of human LH hormone (Luveris) during the final days of stimulation with recombinant FSH (Gonal-f) for controlled ovarian stimulation will be of benefit for patients undergoing in vitro fertilisation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age below 40\n* Infertility treatable by IVF or ICSI\n* Regular cycles\n\nExclusion Criteria:\n\n* NA'}, 'identificationModule': {'nctId': 'NCT00553293', 'briefTitle': 'Nordic Luveris Study', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Recombinant LH Supplementation to Recombinant FSH During the Final Days of Controlled Ovarian Stimulation for IVF: a Multicentre, Prospective, Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': 'KF02-035/03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A,1', 'description': 'rFSH + rLH arm', 'interventionNames': ['Drug: recombinant luteinizing hormone (Luveris)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'A,2', 'description': 'rFSH alone', 'interventionNames': ['Drug: recombinant follicle stimulating hormone (Gonal-f)']}], 'interventions': [{'name': 'recombinant luteinizing hormone (Luveris)', 'type': 'DRUG', 'otherNames': ['Luveris'], 'description': '75 iu/day form cycle day 6', 'armGroupLabels': ['A,1']}, {'name': 'recombinant follicle stimulating hormone (Gonal-f)', 'type': 'DRUG', 'otherNames': ['Gonal-f'], 'description': 'rFSH 150 iu/day', 'armGroupLabels': ['A,2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'state': 'Copenhagen', 'country': 'Denmark', 'facility': 'Anders Nyboe Andersen', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Anders N Andersen, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fertility Clinic Rigshospitalet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Regionshospitalet Viborg, Skive', 'class': 'OTHER'}, {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, {'name': 'Helse Fonna', 'class': 'OTHER'}, {'name': 'Turku Hospital', 'class': 'UNKNOWN'}, {'name': 'Odense University Hospital', 'class': 'OTHER'}, {'name': 'Herlev Hospital', 'class': 'OTHER'}, {'name': 'Holbaek Sygehus', 'class': 'OTHER'}, {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}]}}}