Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-03-02 @ 4:05 AM
Study NCT ID:
NCT02330705
Status:
UNKNOWN
Last Update Posted:
2019-01-25
First Post:
2014-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Timing of HCG Administration in IUI Cycles
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': 'D006063', 'term': 'Chorionic Gonadotropin'}], 'ancestors': [{'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010926', 'term': 'Placental Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011257', 'term': 'Pregnancy Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 225}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-24', 'studyFirstSubmitDate': '2014-12-31', 'studyFirstSubmitQcDate': '2015-01-01', 'lastUpdatePostDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '4-6 weeks after IUI', 'description': 'Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after IUI) divided by the number of IUI cycles'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Intrauterine insemination', 'IUI', 'HCG'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'Evaluation of the effect of altering the timing of human chorionic gonadotropin (HCG) administration on the clinical pregnancy rate in intrauterine insemination (IUI) cycles.', 'detailedDescription': 'Women will be randomly divided into 3 groups; the first group will undergo IUI at the time HCG administration, the second group will undergo IUI 12 hours after HCG administration and the third group will undergo IUI 34-36 hours after HCG administration.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mild male factor infertility or unexplained infertility.\n\nExclusion Criteria:\n\n* Advanced male factor infertility.\n* Polycystic ovary syndrome (PCOS) as defined by the Rotterdam criteria.\n* Endometriosis.\n* Tubal disease.\n* Uterine abnormalities or myoma.\n* Previous uterine surgery.\n* Metabolic or hormonal abnormalities.'}, 'identificationModule': {'nctId': 'NCT02330705', 'briefTitle': 'Timing of HCG Administration in IUI Cycles', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Timing of Human Chorionic Gonadotropin Administration in Intrauterine Insemination Cycles', 'orgStudyIdInfo': {'id': 'MIE3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'IUI at time of HCG', 'interventionNames': ['Drug: HCG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'IUI 12 hours after HCG', 'interventionNames': ['Drug: HCG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C', 'description': 'IUI 34-36 hours after HCG', 'interventionNames': ['Drug: HCG']}], 'interventions': [{'name': 'HCG', 'type': 'DRUG', 'otherNames': ['Pregnyl'], 'description': 'Women will be given HCG before IUI', 'armGroupLabels': ['Group A', 'Group B', 'Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35111', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed I Eid, Dr', 'role': 'CONTACT', 'email': 'dr_moh_eid@yahoo.com', 'phone': '+201225401274'}], 'facility': 'Fertility care unit (FCU) in Mansoura University Hospitals', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}, {'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Private fertility care centers', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Mohamed I Eid, Dr', 'role': 'CONTACT', 'email': 'dr_moh_eid@yahoo.com', 'phone': '+201225401274'}], 'overallOfficials': [{'name': 'Mohamed I Eid, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mansoura University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mohamed Ibrahem Eid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Mohamed Ibrahem Eid', 'investigatorAffiliation': 'Mansoura University'}}}}