Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2026-01-04 @ 4:43 AM
Study NCT ID:
NCT01291212
Status:
UNKNOWN
Last Update Posted:
2011-02-08
First Post:
2011-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Luteinizing Hormone (LH) Activity in Low Responder Patients With Transdermal Testosterone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013739', 'term': 'Testosterone'}], 'ancestors': [{'id': 'D000737', 'term': 'Androstenols'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045165', 'term': 'Testosterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-02-07', 'studyFirstSubmitDate': '2011-02-07', 'studyFirstSubmitQcDate': '2011-02-07', 'lastUpdatePostDateStruct': {'date': '2011-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ovarian response', 'timeFrame': 'within 2 weeks after begining ovarian stimulation', 'description': 'number of oocytes obtained per ovarian stimulation cycle'}], 'secondaryOutcomes': [{'measure': 'clinical pregnancy rate', 'timeFrame': 'within 5 weeks (plus or minus 1 week) after embryo transfer', 'description': 'The number of clinical pregnancies expressed per embryo transfer cycles. Clinical pregnancy: a pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy. Multiple gestational sacs are counted as one clinical pregnancy.'}, {'measure': 'Implantation rate', 'timeFrame': 'within 5 weeks (plus/minus 1 week) after embryo transfer', 'description': 'The number of gestational sacs (observed by ultrasound examination) divided by the number of embryos transferred.'}, {'measure': 'Live birth rate', 'timeFrame': 'within 9 months (plus/minus 1 month) after embryo transfer', 'description': 'The number of deliveries that resulted in at least one live born baby expressed per 100 embryo transfer cycles.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['In Vitro Fertilization', 'Testosterone', 'Ovarian Stimulation', 'Luteinizing Hormone'], 'conditions': ['Other Complications Associated With Artificial Fertilization']}, 'referencesModule': {'references': [{'pmid': '16517559', 'type': 'BACKGROUND', 'citation': 'Balasch J, Fabregues F, Penarrubia J, Carmona F, Casamitjana R, Creus M, Manau D, Casals G, Vanrell JA. Pretreatment with transdermal testosterone may improve ovarian response to gonadotrophins in poor-responder IVF patients with normal basal concentrations of FSH. Hum Reprod. 2006 Jul;21(7):1884-93. doi: 10.1093/humrep/del052. Epub 2006 Mar 3.'}, {'pmid': '19054777', 'type': 'RESULT', 'citation': 'Fabregues F, Penarrubia J, Creus M, Manau D, Casals G, Carmona F, Balasch J. Transdermal testosterone may improve ovarian response to gonadotrophins in low-responder IVF patients: a randomized, clinical trial. Hum Reprod. 2009 Feb;24(2):349-59. doi: 10.1093/humrep/den428. Epub 2008 Dec 3.'}]}, 'descriptionModule': {'briefSummary': 'The investigators have previously demonstrated the utility of transdermal testosterone in in vitro fertilization (IVF) low responder patients. Now, the investigators want to evaluate the efficacy of luteinizing hormone (LH) activity added to recombinant follicular stimulating hormone (FSHr) during ovarian stimulation in these patients.', 'detailedDescription': 'Studies in macaques have indicated that androgens have some synergistic effects with follicular stimulating hormone (FSH) on folliculogenesis. Our previous clinical studies demonstrated the usefulness of pretreatment with transdermal testosterone in low-responder IVF patients.\n\nThere is controversy on the usefulness of recombinant luteinizing hormone (LHr) added to FSHr in ovarian stimulation of low responder patients. Thus, our present study has been designed to compare ovarian stimulation with FSHr alone versus LHr added to FSHr when transdermal testosterone pretreatment is used.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '41 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Low responder patients: patients with previously canceled cycle or recovery of 3 or less oocytes\n\nExclusion Criteria:\n\n* FSH \\> 12\n* Previous ovarian surgery'}, 'identificationModule': {'nctId': 'NCT01291212', 'briefTitle': 'Efficacy of Luteinizing Hormone (LH) Activity in Low Responder Patients With Transdermal Testosterone', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Efficacy of LH Activity in Low Responder Patients With Transdermal Testosterone: a Randomised Controlled Study.', 'orgStudyIdInfo': {'id': 'FIV-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Testosterone and FSHr', 'interventionNames': ['Drug: testosterone and FSHr alone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'testosterone and FSHr-LHr', 'interventionNames': ['Drug: Testosterone and FSHr-LHr']}], 'interventions': [{'name': 'Testosterone and FSHr-LHr', 'type': 'DRUG', 'description': '75U of LHr added to FSHr ovarian stimulation in IVF, when testosterone was used to improve the ovarian response', 'armGroupLabels': ['testosterone and FSHr-LHr']}, {'name': 'testosterone and FSHr alone', 'type': 'DRUG', 'description': 'FSHr alone used in ovarian stimulation in IVF, when testosterone was used to improve the ovarian response', 'armGroupLabels': ['Testosterone and FSHr']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clínic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Francisco Fábregues', 'oldOrganization': 'Hospital Clínic'}}}}