Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-25 @ 7:08 PM
Study NCT ID:
NCT03425604
Status:
COMPLETED
Last Update Posted:
2020-02-12
First Post:
2018-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of Intrauterine Insemination in Patients With Endometriosis I-II
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9979}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-11', 'studyFirstSubmitDate': '2018-02-01', 'studyFirstSubmitQcDate': '2018-02-01', 'lastUpdatePostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pregnancy rate', 'timeFrame': '2011-2017', 'description': 'to compare pregnancy rate between Endometriosis I-II patients (according to ASRM classification) vs. control group (patients without endometriosis) going under an IUI cycle'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endometriosis I-II']}, 'descriptionModule': {'briefSummary': 'Intrauterine insemination (IUI) is an ART that provides good results in selected patients, improving their reproductive prognosis. Endometriosis I y II, according to ASRM classification, remains an indication to perform IUI. This indication is on continuous debate, considering that different studies have shown controversial results about it, due to the poor reproductive outcomes in this group of patients'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '38 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We analyzed the database (SIVIS) containing information on IUI treatment cycles carried out at the IVI-Clinics between 2011 and 2017.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\\< 38 years old women, antral follicle count \\> 6, basal FSH \\< 10mUI/ml, BMI\\<30, Infertility time \\<4 years, absence of uterine malformations, endometrial polyps or myomas, absence of known thrombofilia, normal kayotype, \\< 3 previous IUI cycles, no male severe factor associated\n\n\\-\n\nExclusion Criteria:\n\n* \\> 38 years old'}, 'identificationModule': {'nctId': 'NCT03425604', 'briefTitle': 'Role of Intrauterine Insemination in Patients With Endometriosis I-II', 'organization': {'class': 'OTHER', 'fullName': 'IVI Bilbao'}, 'officialTitle': 'Role of Intrauterine Insemination in Patients With Endometriosis I-II', 'orgStudyIdInfo': {'id': 'IVIBILBAO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Endometriosis I y II, according to ASRM classification', 'description': 'Cycles were chosen for analysis only when all the following selection criteria were satisfied: \\< 38 years old women, antral follicle count \\> 6, basal FSH \\< 10mUI/ml, BMI\\<30, Infertility time \\<4 years, absence of uterine malformations, endometrial polyps or myomas, absence of known thrombofilia, normal kayotype, \\< 3 previous IUI cycles, no male severe factor associated', 'interventionNames': ['Procedure: Intrauterine insemination']}, {'label': 'patients without endometriosis', 'description': 'Cycles were chosen for analysis only when all the following selection criteria were satisfied: \\< 38 years old women, antral follicle count \\> 6, basal FSH \\< 10mUI/ml, BMI\\<30, Infertility time \\<4 years, absence of uterine malformations, endometrial polyps or myomas, absence of known thrombofilia, normal kayotype, \\< 3 previous IUI cycles, no male severe factor associated', 'interventionNames': ['Procedure: Intrauterine insemination']}], 'interventions': [{'name': 'Intrauterine insemination', 'type': 'PROCEDURE', 'armGroupLabels': ['Endometriosis I y II, according to ASRM classification', 'patients without endometriosis']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IVI Bilbao', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}