Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2026-02-26 @ 12:05 PM
Study NCT ID:
NCT02684604
Status:
COMPLETED
Last Update Posted:
2016-05-16
First Post:
2016-02-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Anti-Helicobacter Pylori Antibodies (IgG) in Serum of Women With Unexplained Infertility
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amr.riad@med.asu.edu.eg', 'phone': '01005347179', 'title': 'amr ahmed mahmoud riad', 'phoneExt': '+2', 'organization': 'Ain Shams Maternity hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Unexplained Infertility Patients', 'description': '44 patients diagnosed to have unexplained infertility', 'otherNumAtRisk': 44, 'otherNumAffected': 0, 'seriousNumAtRisk': 44, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fertile Women', 'description': '44 fertile women', 'otherNumAtRisk': 44, 'otherNumAffected': 0, 'seriousNumAtRisk': 44, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Quantitative Helicobacter Pylori IgG Assay in Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unexplained Infertility Patients', 'description': '44 patients diagnosed to have unexplained infertility'}, {'id': 'OG001', 'title': 'Fertile Women', 'description': '44 fertile women'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '70'}, {'value': '70', 'groupId': 'OG001', 'lowerLimit': '70', 'upperLimit': '70'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours', 'description': 'calculation of quantitative Helicobacter pylori IgG assay in serum', 'unitOfMeasure': 'arbitrary unit per millilitre', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Unexplained Infertility Patients', 'description': '44 patients diagnosed to have unexplained infertility'}, {'id': 'FG001', 'title': 'Fertile Women', 'description': '44 fertile women'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Unexplained Infertility Patients', 'description': '44 patients diagnosed to have unexplained infertility'}, {'id': 'BG001', 'title': 'Fertile Women', 'description': '44 fertile women'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.3', 'spread': '5.4', 'groupId': 'BG000'}, {'value': '27.8', 'spread': '4.9', 'groupId': 'BG001'}, {'value': '28.06', 'spread': '5.12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'parity', 'classes': [{'title': 'nullipara', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': 'para 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'para 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'para 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'para 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'type of infertility', 'classes': [{'title': 'no infertility', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': 'primary infertility', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': 'secondary infertility', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'serum FSH level', 'classes': [{'categories': [{'measurements': [{'value': '6.85', 'spread': '2.17', 'groupId': 'BG000'}, {'value': '4.21', 'spread': '1.85', 'groupId': 'BG001'}, {'value': '5.53', 'spread': '3.12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'international unit per litre', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'serum LH level', 'classes': [{'categories': [{'measurements': [{'value': '5.43', 'spread': '2.69', 'groupId': 'BG000'}, {'value': '4.41', 'spread': '3.21', 'groupId': 'BG001'}, {'value': '4.92', 'spread': '2.11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'international unit per litre', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'serum prolactin level', 'classes': [{'categories': [{'measurements': [{'value': '8.23', 'spread': '3.39', 'groupId': 'BG000'}, {'value': '9.21', 'spread': '4.91', 'groupId': 'BG001'}, {'value': '8.72', 'spread': '3.45', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'nanogram per millilitre', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'serum estradiole level', 'classes': [{'categories': [{'measurements': [{'value': '47.56', 'spread': '16.55', 'groupId': 'BG000'}, {'value': '34.52', 'spread': '12.41', 'groupId': 'BG001'}, {'value': '41.04', 'spread': '14.02', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'picogram per millilitre', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'serum progesterone level', 'classes': [{'categories': [{'measurements': [{'value': '14.09', 'spread': '4.91', 'groupId': 'BG000'}, {'value': '15.01', 'spread': '5.21', 'groupId': 'BG001'}, {'value': '14.55', 'spread': '5.52', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'nanogram per millilitre', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Normally distributed numerical variables were presented as mean and SD, and skewed variables as median and interquartile range. Comparison of normally distributed numerical data was done using the unpaired t test. Skewed data were compared using the Mann-Whitney U test. Ordinal data were compared using the chi-squared test for trend.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-10', 'studyFirstSubmitDate': '2016-02-08', 'resultsFirstSubmitDate': '2016-03-03', 'studyFirstSubmitQcDate': '2016-02-17', 'lastUpdatePostDateStruct': {'date': '2016-05-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-03-03', 'studyFirstPostDateStruct': {'date': '2016-02-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantitative Helicobacter Pylori IgG Assay in Serum', 'timeFrame': '24 hours', 'description': 'calculation of quantitative Helicobacter pylori IgG assay in serum'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Infertility, Female']}, 'descriptionModule': {'briefSummary': "Prevalence of anti-H.pylori IgG in serum of women with unexplained infertility and comparing that with it's prevalence in fertile women.", 'detailedDescription': 'Unexplained infertility was diagnosed according to standard World Health Organization (WHO) criteria. All women in the study had hormonal assessment to evaluate their ovulatory cycles, thyroid function, circulating prolactin and androgen levels. The ovarian reserve was checked by measurement of serum FSH and an antral follicle count on the third day of the menstrual cycle. Screening for infertility also included transvaginal ultrasound and hysterosalpingography, to exclude possible uterine malformations or pathologies, and to assess the patency of the fallopian tubes. Male factor infertility was excluded in all couples, according to standard WHO semen analysis.\n\nFollowing admission, all patients underwent complete clinical examination and detailed medical history was obtained.\n\nA venous sample was collected to test serum for HP IgG seropositivity by enzyme linked immunoassay for HELICOBACTOR PYLORI IgG (ENZYME IMMUNOASSAY TEST KIT).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'female healthy participants who attend the outpatient clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. regular cycles.\n2. normal thyroid function, prolactin and androgen levels.\n3. normal semen analysis of the partner.\n4. normal hysterosalpingography.\n5. normal transvaginal ultrasound examination.\n\nExclusion Criteria:\n\n1. possible uterine malformations or pathologies.\n2. presence of infections, including hepatitis, human immunodeficiency virus (HIV), TORCH, Chlamydia trachomatis and Mycoplasma.\n3. presence of anti-sperm antibodies in serum.\n4. Male factor infertility.'}, 'identificationModule': {'nctId': 'NCT02684604', 'briefTitle': 'Anti-Helicobacter Pylori Antibodies (IgG) in Serum of Women With Unexplained Infertility', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams Maternity Hospital'}, 'officialTitle': 'Anti-Helicobacter Pylori Antibodies (IgG) in Serum of Women With Unexplained Infertility', 'orgStudyIdInfo': {'id': 'unexplained infertility'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'unexplained infertility patients', 'description': '44 patients diagnosed to have unexplained infertility'}, {'label': 'Fertile women', 'description': '44 fertile women'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams Maternity Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of obstetrics and gynecology', 'investigatorFullName': 'Amr Ahmed Mahmoud Riad', 'investigatorAffiliation': 'Ain Shams Maternity Hospital'}}}}