Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2026-01-05 @ 5:47 PM
Study NCT ID:
NCT03289403
Status:
COMPLETED
Last Update Posted:
2024-12-27
First Post:
2017-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Immunomodulatory Treatment in Success of ICSI in Patients With Autoimmune Thyroiditis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}, {'id': 'D013967', 'term': 'Thyroiditis, Autoimmune'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D013966', 'term': 'Thyroiditis'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013974', 'term': 'Thyroxine'}], 'ancestors': [{'id': 'D013963', 'term': 'Thyroid Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 194}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-23', 'studyFirstSubmitDate': '2017-09-17', 'studyFirstSubmitQcDate': '2017-09-19', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Number of Participants Who Achieved clinical Pregnancy', 'timeFrame': '6 weeks after embryo transfer'}], 'secondaryOutcomes': [{'measure': 'The Number of Participants Who Achieved Ongoing Pregnancy', 'timeFrame': '18 weeks after embryo transfer'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility', 'Autoimmune Thyroiditis']}, 'descriptionModule': {'briefSummary': 'The aim of the work is to determine whether the use of immunomodulatory drugs could improve the reproductive of outcome of infertile patients who have autoimmune thyroiditis with positive autoimmune antibodies undergoing IVF-ET.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infertility patients who have autoimmune thyroiditis With positive autoimmune thyroiditis and TSH level above 2 IU.\n\nExclusion Criteria:\n\n* All patients who have other autoimmune diseases especially antiphospholipid syndrome, hepatitis c viral disease.\n\nPatients who have any medical disorders ( eg. D.M. HTN .Epilepsy ….)'}, 'identificationModule': {'nctId': 'NCT03289403', 'briefTitle': 'The Role of Immunomodulatory Treatment in Success of ICSI in Patients With Autoimmune Thyroiditis', 'organization': {'class': 'OTHER', 'fullName': 'Aljazeera Hospital'}, 'officialTitle': 'The Role of Immunomodulatory Treatment in Success of ICSI in Patients Who Have Infertility With Autoimmune Thyroiditis', 'orgStudyIdInfo': {'id': 'ICSI/ Autoimmune thyroiditis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D and immunomodulatory drugs(prednisolone, hydroxychloroquine, azathioprin, IV immunoglobulins)', 'interventionNames': ['Drug: Immunomodulatory']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D.', 'interventionNames': ['Drug: Thyroxine']}], 'interventions': [{'name': 'Immunomodulatory', 'type': 'DRUG', 'description': 'Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D before ICSI cycle.\n\nMoreover, patients will receive a treatment course of immunomodulatory drugs for 3 -6 months before ICSI cycle:\n\n1. Prednisnlone 40mg for 2 weeks to be lowered gradually till become 5mg after 6 weeks and to be continued\n2. Hydroxychloroquine according to body weight, patients who develop hypersensitivity will be shifted to Azathioprin.\n3. Immunoglobulins will be used in cases not responding to treatment.', 'armGroupLabels': ['Study group']}, {'name': 'Thyroxine', 'type': 'DRUG', 'description': 'Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D before ICSI cycle.\n\nPatients will not receive immunomodulatory drugs', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'country': 'Egypt', 'facility': 'Aljazeera (Al Gazeera) hospital', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Ahmed M Sayed, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Aljazeera (Al Gazeera) hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aljazeera Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}