Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2025-12-25 @ 7:50 PM
Study NCT ID:
NCT01427335
Status:
COMPLETED
Last Update Posted:
2014-07-09
First Post:
2011-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Calcium for Prevention of Ovarian Hyperstimulation Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016471', 'term': 'Ovarian Hyperstimulation Syndrome'}], 'ancestors': [{'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'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': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002118', 'term': 'Calcium'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-08', 'studyFirstSubmitDate': '2011-08-31', 'studyFirstSubmitQcDate': '2011-08-31', 'lastUpdatePostDateStruct': {'date': '2014-07-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'OHSS rate', 'timeFrame': '2 years', 'description': 'ovarain hyperstimulation syndrome'}], 'secondaryOutcomes': [{'measure': 'clinical pregnancy rate', 'timeFrame': '2 years', 'description': 'positive pregnancy test and positive fetal heart beat after 6 weeks gestaional age'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['OHSS', 'ICSI', 'calcium injection'], 'conditions': ['Ovarian Hyperstimulation Syndrome']}, 'referencesModule': {'references': [{'pmid': '25552412', 'type': 'DERIVED', 'citation': 'El-Khayat W, Elsadek M. Calcium infusion for the prevention of ovarian hyperstimulation syndrome: a double-blind randomized controlled trial. Fertil Steril. 2015 Jan;103(1):101-5. doi: 10.1016/j.fertnstert.2014.09.046.'}]}, 'descriptionModule': {'briefSummary': 'There are many protocols for prevention of ovarian hyperstimulation syndrome, intravenous calcium is a novel protocol. But still there is lack of evidence of it is real effect in prevention of OHSS \\& the mechanism of its action is still questionable . In the study the investigators try to search for the evidence for its effect \\& the real mechanism for its action.', 'detailedDescription': 'The study population will be divided into 2groups each containing 100 infertile couples candidate for ICSI.\n\nGroup (A)active group: administration of 10% Intravenous calcium gluconate 10 ml in 200 mL of physiologic saline on the day of ovum pickup, day 1,day 2, and day 3 after ovum pickup. Intravenous infusion was performed within 30 minutes.\n\nGroup (B): placebo group: administration of 200 mL of 0.9% saline on the day of ovum pickup, day 1,day 2, and day 3 after ovum pickup. Intravenous infusion was performed within 30 minutes'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '38 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* infertile women aged 20 to 38 years.\n* BMI ranged from 18 to 40.\n* serum FSH within normal limits( 1-12IU /l)\n* presented with ovarian response suggestive of being at risk of developing OHSS because of the presence of at least 15 follicles of 10 mm or greater on the day of hCG administration.\n\nExclusion Criteria:\n\n* endocrinopathies.\n* a systemic disease.\n* using any medication (e.g., insulin-sensitizing drugs and GnRH antagonists.\n* patients need coasting for high risk of OHSS.\n* patients need cycle cancellation.\n* severe male infertility requiring testicular sperm extraction.'}, 'identificationModule': {'nctId': 'NCT01427335', 'acronym': 'OHSS', 'briefTitle': 'Calcium for Prevention of Ovarian Hyperstimulation Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Does Intravenous Calcium Infusion Effectively Prevent OHSS : a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '192011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'saline', 'description': '0.9% saline intravenous infusion', 'interventionNames': ['Drug: 0.9 % saline']}, {'type': 'EXPERIMENTAL', 'label': 'calcium', 'description': 'Calcium intravenous infusion', 'interventionNames': ['Drug: calcium']}], 'interventions': [{'name': 'calcium', 'type': 'DRUG', 'otherNames': ['Calcium intravenous infsuion'], 'description': 'intravenous infusion of 10 % calcium gluconate 10 mL in 200 mL of physiologic saline on the day of ovum pickup, day 1,day 2, and day 3 after ovum pickup were administered in study group.\n\nIntravenous infusion was performed within 30 minutes', 'armGroupLabels': ['calcium']}, {'name': '0.9 % saline', 'type': 'DRUG', 'description': '0.9 % saline intravenous infusion', 'armGroupLabels': ['saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12211', 'city': 'Cairo', 'state': 'Cario', 'country': 'Egypt', 'facility': 'Kasr elini hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Waleed M El-Khayat, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Waleed El-khayat', 'investigatorAffiliation': 'Cairo University'}}}}