Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-30 @ 11:44 AM
Study NCT ID:
NCT02492451
Status:
TERMINATED
Last Update Posted:
2016-10-20
First Post:
2015-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Endometrial Injury Versus Luteal Phase Support in Intrauterine Insemination Cycles
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011374', 'term': 'Progesterone'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003339', 'term': 'Corpus Luteum Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045167', 'term': 'Progesterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'md_sel@hotmail.com', 'phone': '+905321630488', 'title': 'Selcuk Selcuk', 'organization': 'Zeynep Kamil Research and Teaching Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Endometrial Injury', 'description': 'Endometrial injury in luteal phase of preceding IUI cycle\n\nEndometrial Injury: Endometrial injury in luteal phase of preceding cycle by pipelle canula', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Luteal Phase Support', 'description': 'Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.\n\nprogesterone (Crinone® %8 vaginal progesterone gel): Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.', 'otherNumAtRisk': 39, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Control Group', 'description': 'Only intrauterine insemination', 'otherNumAtRisk': 39, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pregnancy Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Endometrial Injury', 'description': 'Endometrial injury in luteal phase of preceding IUI cycle\n\nEndometrial Injury: Endometrial injury in luteal phase of preceding cycle by pipelle canula'}, {'id': 'OG001', 'title': 'Luteal Phase Support', 'description': 'Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.\n\nprogesterone (Crinone® %8 vaginal progesterone gel): Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Only intrauterine insemination'}], 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000'}, {'value': '17.9', 'groupId': 'OG001'}, {'value': '5.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'ongoing pregnancy rates', 'unitOfMeasure': 'percentage of ongoing pregnancies', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Endometrial Injury', 'description': 'Endometrial injury in luteal phase of preceding IUI cycle\n\nEndometrial Injury: Endometrial injury in luteal phase of preceding cycle by pipelle canula'}, {'id': 'FG001', 'title': 'Luteal Phase Support', 'description': 'Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.\n\nprogesterone (Crinone® %8 vaginal progesterone gel): Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.'}, {'id': 'FG002', 'title': 'Control Group', 'description': 'Only intrauterine insemination'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '118', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Endometrial Injury', 'description': 'Endometrial injury in luteal phase of preceding IUI cycle\n\nEndometrial Injury: Endometrial injury in luteal phase of preceding cycle by pipelle canula'}, {'id': 'BG001', 'title': 'Luteal Phase Support', 'description': 'Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.\n\nprogesterone (Crinone® %8 vaginal progesterone gel): Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.'}, {'id': 'BG002', 'title': 'Control Group', 'description': 'Only intrauterine insemination'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.85', 'spread': '5.45', 'groupId': 'BG000'}, {'value': '28.13', 'spread': '4.41', 'groupId': 'BG001'}, {'value': '29.95', 'spread': '5.44', 'groupId': 'BG002'}, {'value': '28.64', 'spread': '5.17', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '118', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'whyStopped': 'Problems in recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-26', 'studyFirstSubmitDate': '2015-06-18', 'resultsFirstSubmitDate': '2016-07-15', 'studyFirstSubmitQcDate': '2015-07-07', 'lastUpdatePostDateStruct': {'date': '2016-10-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-08-26', 'studyFirstPostDateStruct': {'date': '2015-07-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pregnancy Rate', 'timeFrame': '12 weeks', 'description': 'ongoing pregnancy rates'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['intrauterine insemination', 'pregnancy rate', 'endometrial injury'], 'conditions': ['Pregnancy']}, 'referencesModule': {'references': [{'pmid': '36278845', 'type': 'DERIVED', 'citation': 'Bui BN, Lensen SF, Gibreel A, Martins WP, Torrance H, Broekmans FJ. Endometrial injury for pregnancy following sexual intercourse or intrauterine insemination. Cochrane Database Syst Rev. 2022 Oct 24;10(10):CD011424. doi: 10.1002/14651858.CD011424.pub4.'}, {'pmid': '33734431', 'type': 'DERIVED', 'citation': 'Bui BN, Lensen SF, Gibreel A, Martins WP, Torrance H, Broekmans FJ. Endometrial injury for pregnancy following sexual intercourse or intrauterine insemination. Cochrane Database Syst Rev. 2021 Mar 18;3(3):CD011424. doi: 10.1002/14651858.CD011424.pub3.'}]}, 'descriptionModule': {'briefSummary': 'The investigators will try to assess the effect of endometrial injury preceding the intrauterine insemination cycle on the pregnancy rates compared to cycles with luteal phase support and the control group.', 'detailedDescription': 'Group 1: Endometrial biopsy is performed on days 21-24 of the spontaneous menstrual cycle proceeding the intrauterine insemination (IUI) treatment cycle. Two small biopsies are obtained from anterior and posterior walls of the uterus.\n\nGroup 2: Vaginal progesterone gel is administered for luteal phase support from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.\n\nGoup 3: Patients are undergone intrauterine insemination (IUI) cycles stimulated with gonadotropin without any intervention.\n\nThe effect of endometrial injury and luteal phase progesterone support on the pregnancy rate in patients intrauterine insemination (IUI) cycles stimulated with gonadotropin will be compared in terms of biochemical pregnancy rate, clinical pregnancy rate and ongoing pregnancy rate.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients are undergone intrauterine insemination with gonadotropin stimulation\n* Bilateral patent fallopian tubes revealed by hysterosalpingography or laparoscopy\n* After semen preparation for intrauterine insemination, total progressive sperm count \\> 5 million\n\nExclusion Criteria:\n\n* endocrin or metabolic disorders,\n* uterine factor,\n* pelvic inflammatory disease,\n* women with basal follicle-stimulating hormone (FSH) level \\>15 IU/mL,\n* body mass index (BMI) ≥ 35 kg/m2,\n* age ≥ 40 and \\< 18 years,'}, 'identificationModule': {'nctId': 'NCT02492451', 'briefTitle': 'Endometrial Injury Versus Luteal Phase Support in Intrauterine Insemination Cycles', 'organization': {'class': 'OTHER', 'fullName': 'Zeynep Kamil Maternity and Pediatric Research and Training Hospital'}, 'officialTitle': 'Endometrial Injury Versus Luteal Phase Support in Intrauterine Insemination Cycles', 'orgStudyIdInfo': {'id': 'zeynepkamil'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Endometrial Injury', 'description': 'Endometrial injury in luteal phase of preceding IUI cycle', 'interventionNames': ['Other: Endometrial Injury']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Luteal Phase Support', 'description': 'Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.', 'interventionNames': ['Drug: progesterone (Crinone® %8 vaginal progesterone gel)']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Only IUI'}], 'interventions': [{'name': 'Endometrial Injury', 'type': 'OTHER', 'description': 'Endometrial injury in luteal phase of preceding cycle by pipelle canula', 'armGroupLabels': ['Endometrial Injury']}, {'name': 'progesterone (Crinone® %8 vaginal progesterone gel)', 'type': 'DRUG', 'description': 'Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.', 'armGroupLabels': ['Luteal Phase Support']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Selcuk Selcuk', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zeynep Kamil Maternity and Pediatric Research and Training Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Selcuk Selcuk', 'investigatorAffiliation': 'Zeynep Kamil Maternity and Pediatric Research and Training Hospital'}}}}