Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT00780858
Status:
COMPLETED
Last Update Posted:
2015-05-06
First Post:
2008-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Premature Luteinization Prevention by GnRH Antagonist in Patients Undergoing IUI
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': 'C061018', 'term': 'ganirelix'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 662}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-05', 'studyFirstSubmitDate': '2008-10-25', 'studyFirstSubmitQcDate': '2008-10-27', 'lastUpdatePostDateStruct': {'date': '2015-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pregnancy rate', 'timeFrame': '2 weeks after intervention'}], 'secondaryOutcomes': [{'measure': 'premature luteinization', 'timeFrame': 'at the time of intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GnRH antagonist', 'IUI'], 'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '17936285', 'type': 'BACKGROUND', 'citation': 'Kosmas IP, Tatsioni A, Kolibianakis EM, Verpoest W, Tournaye H, Van der Elst J, Devroey P. Effects and clinical significance of GnRH antagonist administration for IUI timing in FSH superovulated cycles: a meta-analysis. Fertil Steril. 2008 Aug;90(2):367-72. doi: 10.1016/j.fertnstert.2007.06.064. Epub 2007 Oct 23.'}]}, 'descriptionModule': {'briefSummary': 'Premature luteinization in patients undergoing IUI can occur in up to 24% of cycles. These patients, according to recent data, have a lower pregnancy rate than controls. The possibility to avoid premature luteinization with GnRH antagonist may restore the chances of achieving a pregnancy in these women.', 'detailedDescription': 'The purpose of this study was to investigate whether a subset of patients benefits from GnRHa administration during IUI. PL was tested for in patients who were undergoing artificial insemination procedures, and the effect of GnRHa on PR in patients who'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy women with patent tubes who were undergoing IUI due to infertily of unknown origin.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* previous failed IUI cycle with premature luteinization\n\nExclusion Criteria:\n\n* 39 years or older\n* not eligible for IUI (patent tubes, \\> 3 million capacitated spermatozoa)\n* 4 previous IUI cycles'}, 'identificationModule': {'nctId': 'NCT00780858', 'acronym': 'LP', 'briefTitle': 'Premature Luteinization Prevention by GnRH Antagonist in Patients Undergoing IUI', 'organization': {'class': 'OTHER', 'fullName': 'IVI Madrid'}, 'officialTitle': 'GnRH Antagonist Prevention of Premature Luteinization in Patients Undergoing IUI', 'orgStudyIdInfo': {'id': 'IVIMAD-JMS-09-2008-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ganirelix', 'description': 'Patients with premature lutenization (progesterone \\>1,2 ng/ml) who did not get pregnant during the first IUI underwent a second IUI.', 'interventionNames': ['Drug: Ganirelix']}, {'label': 'Control', 'description': 'Patients without premature lutenization (progesterone \\>1,2 ng/ml) underwent a only one IUI.'}], 'interventions': [{'name': 'Ganirelix', 'type': 'DRUG', 'otherNames': ['Orgalutran'], 'description': 'Ganirelix 0.25mg s.c every 24 h starting stimulation day 6', 'armGroupLabels': ['Ganirelix']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28023', 'city': 'Madrid', 'country': 'Spain', 'facility': 'IVI-Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Juan antonio García-Velasco, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IVI Madrid'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IVI Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Juan A Garcia-Velasco', 'investigatorAffiliation': 'IVI Madrid'}}}}