Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-03-03 @ 8:15 AM
Study NCT ID:
NCT02290002
Status:
COMPLETED
Last Update Posted:
2017-02-14
First Post:
2014-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Calcium Dobesilate Versus Coasting for Prevention of Ovarian Hyperstimulation Syndrome
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': 'D002123', 'term': 'Calcium Dobesilate'}], 'ancestors': [{'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-13', 'studyFirstSubmitDate': '2014-11-08', 'studyFirstSubmitQcDate': '2014-11-12', 'lastUpdatePostDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with ovarian hyperstimulation syndrome (OHSS)', 'timeFrame': 'every two weeks for eight weeks', 'description': 'this will be assessed by:\n\nClinically:\n\nAbdominal bloating Mild abdominal pain Nausea ± vomiting Oliguria Acute respiratory distress syndrome\n\nBy ultrasound Ovarian size usually ˃8 cm Ultrasound evidence of ascites\n\nLaboratory Haemoconcentration haematocrit ˃45% Hypoproteinaemia'}], 'secondaryOutcomes': [{'measure': 'pregnancy rate', 'timeFrame': '14 days after embryos transfer', 'description': 'β-hCG (serum hCG test) will be checked 14 days after embryos transfer'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effect of oral Calcium Dobesilate versus costing in the prevention of ovarian hyperstimulation syndrome (OHSS) in high-risk women underwent intracytoplasmic sperm injection (ICSI).', 'detailedDescription': 'Two hundred and twenty women at risk of ovarian hyperstimulation syndrome during ICSI cycles will be randomly scheduled into two equal groups. In group A, (Calcium Dobesilate group), 1 cap / 8 hs Doxium ( 500mg) will be given at day of HCG injection and for 3 weeks ; while in group B (Coasting group), coasting (withholding gonadotrophins while maintaining pituitary suppression) follow up every day by measuring E2 for 3 days then either giving triggering or cycle cancellation is done'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '23 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infertile women undergoing intracytoplasmic sperm injection or polycystic ovarian syndrome (PCO) with one of the following:\n\n * Presence of more than 20 follicles by ultrasound\n * E2 more than 3000 pg/ml\n * Retrieval of more than 15 follicles\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02290002', 'briefTitle': 'Calcium Dobesilate Versus Coasting for Prevention of Ovarian Hyperstimulation Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Calcium Dobesilate Versus Coasting for Prevention of Ovarian Hyperstimulation Syndrome', 'orgStudyIdInfo': {'id': 'ahmed-khalid 8'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group A', 'description': 'In group A, (Calcium Dobesilate group), 1 cap / 8 hs Calcium Dobesilate ( 500mg) will be given from at day of HCG injection and for 21 days.', 'interventionNames': ['Drug: Calcium Dobesilate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group B', 'description': 'In group B, coasting (withholding gonadotrophins while maintaining pituitary suppression) for 3 days then either giving triggering or cycle cancellation is done', 'interventionNames': ['Other: coasting']}], 'interventions': [{'name': 'Calcium Dobesilate', 'type': 'DRUG', 'otherNames': ['doxium'], 'description': '1 cap / 8 hs Calcium Dobesilate ( 500mg) will be given at day of HCG injection and for 21 days', 'armGroupLabels': ['group A']}, {'name': 'coasting', 'type': 'OTHER', 'description': 'In group B, coasting (withholding gonadotrophins while maintaining pituitary suppression) for 3 days then either giving triggering or cycle cancellation is done', 'armGroupLabels': ['group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13518', 'city': 'Banhā', 'country': 'Egypt', 'facility': 'Benha univesity hospital', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}], 'overallOfficials': [{'name': 'ahmed saad, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'lecturer of ob/gyn'}, {'name': 'khalid mohamed, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'lecturer of ob/gyn'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'khalid abd aziz mohamed', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'lecturer of ob/gyn', 'investigatorFullName': 'khalid abd aziz mohamed', 'investigatorAffiliation': 'Benha University'}}}}