Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2026-01-24 @ 11:16 PM
Study NCT ID:
NCT03670758
Status:
UNKNOWN
Last Update Posted:
2018-09-14
First Post:
2018-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protein S Activity in Women With Unexplained Infertility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-09-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-09-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-12', 'studyFirstSubmitDate': '2018-09-12', 'studyFirstSubmitQcDate': '2018-09-12', 'lastUpdatePostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Protein S activity', 'timeFrame': 'six months', 'description': 'venous blood sample'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Unexplained Female Infertility']}, 'descriptionModule': {'briefSummary': 'This study will add:\n\nFinding out an association between Protein S activity and unexplained female infertility.\n\nAim:\n\nStudy hypothesis:\n\nIn women with unexplained infertility protein S activity may be low.\n\nStudy question:\n\nIn women with unexplained infertility does protein S activity low?.\n\nThis study aims to assess the activity of protein S activity in women with unexplained infertility.\n\nObjectives:\n\nThe main objective of this study is:\n\nTo determine the prevalence of Protein S activity with unexplained female infertility and to compare its prevalence in fertile women among women attending outpatient clinics at Ain Shams University Maternity Hospital.', 'detailedDescription': "1. Type of Study: Case Control Study.\n2. Study Setting: Ain Shams University Maternity Hospital: outpatient Infertility clinic and outpatient gynecology clinic.\n3. Study Population: The study will include women with unexplained infertility (Group 1; cases) and fertile women who got pregnant and delivered at least once in the previous year with no history of recurrent abortions nor history of secondary infertility (Group 2; control).\n\nGroup 1: Will include 30 women with unexplained primary infertility; will be recruited from the outpatient infertility clinic.\n\nGroup 2; another 30 fertile women who got pregnant and delivered at least once in the previous year with no history of recurrent abortions; will recruited from outpatient gynecology clinic as control.\n\nAccording to inclusion and exclusion criteria listed below.\n\nInclusion criteria:\n\n1. Age: 18 - 35 years old.\n2. Normal husband's semen analysis, (WHO criteria):\n\n 1. Count ≥ 15 million/ml.\n 2. Motility: ≥ 40%\n 3. Morphology: ≥ 4% normal morphology.\n3. Documented ovulation.\n4. Normal Follicle Stimulating Hormone, Luteinizing Hormone, Thyroid Stimulating Hormone, serum prolactin.\n5. Patent Fallopian tubes.\n6. Normal uterine cavity.\n\nExclusion criteria:\n\n1. Patients aged less than 18 years or more than 35 years old.\n2. Secondary infertility\n3. Presence of male factor infertility\n4. Anovulatory cycles.\n5. Tubal block; Tubal disease is an important cause of infertility and should be specifically excluded.\n6. Medical disorder that might affect pregnancy (e.g.: Diabetes, Thyroid dysfunction)\n7. Patients with recurrent abortion."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will include women with unexplained infertility (Group 1; cases) and fertile women who got pregnant and delivered at least once in the previous year with no history of recurrent abortions nor history of secondary infertility (Group 2; control).', 'genderDescription': 'The study will include women with unexplained infertility', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age: 18 - 35 years old.\n2. Normal husband's semen analysis, (WHO criteria):\n\n 1. Count ≥ 15 million/ml.\n 2. Motility: ≥ 40%\n 3. Morphology: ≥ 4% normal morphology.\n3. Documented ovulation.\n4. Normal Follicle Stimulating Hormone, Luteinizing Hormone, Thyroid Stimulating Hormone, serum prolactin.\n5. Patent Fallopian tubes.\n6. Normal uterine cavity.\n\n \\-\n\nExclusion Criteria:\n\n1. Patients aged less than 18 years or more than 35 years old.\n2. Secondary infertility\n3. Presence of male factor infertility\n4. Anovulatory cycles.\n5. Tubal block; Tubal disease is an important cause of infertility and should be specifically excluded.\n6. Medical disorder that might affect pregnancy (e.g.: Diabetes, Thyroid dysfunction)\n7. Patients with recurrent abortion. -"}, 'identificationModule': {'nctId': 'NCT03670758', 'briefTitle': 'Protein S Activity in Women With Unexplained Infertility', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams Maternity Hospital'}, 'officialTitle': 'Protein S Activity in Women With Unexplained Infertility', 'orgStudyIdInfo': {'id': 'AinShamsMH EAhmed'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Will include 30 women with unexplained primary infertility; will be recruited from the outpatient infertility clinic', 'interventionNames': ['Diagnostic Test: Protein S activity']}, {'label': 'Group 2', 'description': 'another 30 fertile women who got pregnant and delivered at least once in the previous year with no history of recurrent abortions; will recruited from outpatient gynecology clinic as control', 'interventionNames': ['Diagnostic Test: Protein S activity']}], 'interventions': [{'name': 'Protein S activity', 'type': 'DIAGNOSTIC_TEST', 'description': 'Intravenous blood sample', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Esraa Gamal Ahmed', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ain Shams Maternity Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Esraa Gamal Ahmed', 'investigatorFullName': 'Esraa Gamal Ahmed', 'investigatorAffiliation': 'Ain Shams Maternity Hospital'}}}}