Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2025-12-28 @ 11:32 AM
Study NCT ID:
NCT01014104
Status:
COMPLETED
Last Update Posted:
2011-07-15
First Post:
2009-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation 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': 'D008775', 'term': 'Methylprednisolone'}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 218}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-14', 'studyFirstSubmitDate': '2009-11-13', 'studyFirstSubmitQcDate': '2009-11-13', 'lastUpdatePostDateStruct': {'date': '2011-07-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence rate of Ovarian hyper stimulation syndrome', 'timeFrame': 'Until 20 days after embryos transfer'}], 'secondaryOutcomes': [{'measure': 'Estradiol concentration in the day before hCG administration', 'timeFrame': 'Until 20 days after embryos transfer'}, {'measure': 'Retrieved and injected oocytes number and quality', 'timeFrame': 'Until 20 days after embryos transfer'}, {'measure': 'Achieved and transferred embryos number and quality', 'timeFrame': 'Until 20 days after embryos transfer'}, {'measure': 'Implantation rate', 'timeFrame': 'Until 20 days after embryos transfer'}, {'measure': 'Chemical and clinical pregnancy rate and cancelation rate', 'timeFrame': 'Until 20 days after embryos transfer'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ovarian hyper stimulation syndrome', 'Methylprednisolone', 'IVF'], 'conditions': ['Ovarian Hyperstimulation Syndrome']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.royaninstitute.org', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study is a prospective randomized clinical controlled trial to assess the efficacy of the Methylprednisolone for preventing ovarian hyper stimulation syndrome in in vitro fertilization (IVF) cycles.', 'detailedDescription': 'Ovarian hyper stimulation syndrome is the most serious complication of ovarian stimulation which might be life threatening in the severe forms. Since there is still no definite cure for this syndrome, prevention is considered as an essential and vital issue. The objective of this study is to determine the effect of Methylprednisolone to prevent ovarian hyper stimulation syndrome in IVF cycles.\n\nThe study population comprises all infertile patients with diagnosis of polycystic ovarian syndrome which will undergo of in-vitro fertilization. The PCO subjects will be recognized based on the Rotterdam criteria inclusive the presence of least 2 signs of oligomenorrhea, hyper androgynism (clinical or laboratory), LH/FSH\\>2 and ovarian morphological evidences in Doppler ultrasound.\n\nThe existence of more than 20 follicles in both ovaries and E2 concentration \\>4000 pg/ml will be considered as the OHSS risk factors.\n\nIn this study all eligible patients will be randomly allocated into two study groups by a computerized randomization method:\n\nTreatment group (case) will be administered 16 mg Methylprednisolone initiated from the first day of stimulation and will be tapered after the first pregnancy test (day 13 after the embryo transfer). Furthermore, these patients will receive a bolus IV dose methylprednisolone, 1g on the day of egg collection and embryo transfer.\n\nPatients in the control group will not receive any treatment with glucocorticoids. If each group confronts with every kind of high risk signs or symptoms, they will undergo coasting or gonadotropin withdrawal or other treatment strategies.\n\nThe presence of OHSS is defined in accordance with the Golan 5 grade system and women who at least are at grade 2 of this classification (Mild) considered as OHSS cases and will experience abdominal distention and discomfort, nausea and vomiting and/or diarrhea and enlargement of ovaries(5-12cm). In Moderate forms, ultrasound evidences of ascites will be observed and severe OHSS accompany with clinical signs of ascites, hydrothorax, breathing disorders, hemoconcentration, coagulopathy and renal perfusion decrease.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Poly Cystic Ovarian Syndrome patients\n* Indication for IVF/ICSI and Long Protocol ovarian stimulation\n* Basal FSH≥10\n* Normal BMI (20-25)\n* physical health\n\nExclusion Criteria:\n\n* Allergy to GnRH analogues, FSH and corticosteroids\n* presence of heart failure, recent myocardial infarction\n* Hypertension\n* Diabetes mellitus\n* epilepsy\n* glaucoma\n* hypothyroidism\n* hepatic failure\n* osteoporosis\n* peptic ulceration\n* renal impairment\n* Using drugs that have interaction with corticosteroids such'}, 'identificationModule': {'nctId': 'NCT01014104', 'briefTitle': 'Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Royan Institute'}, 'officialTitle': 'Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome in In-vitro Fertilization Cycles: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Royan-Emb-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Case', 'description': 'Administration of Methylprednisolone', 'interventionNames': ['Drug: Methylprednisolone']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'interventionNames': ['Drug: Control']}], 'interventions': [{'name': 'Methylprednisolone', 'type': 'DRUG', 'otherNames': ['Case'], 'description': 'Administration of Methylprednisolone', 'armGroupLabels': ['Case']}, {'name': 'Control', 'type': 'DRUG', 'description': 'Normal salin injection', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14114', 'city': 'Tehran', 'state': 'Tehran Province', 'country': 'Iran', 'facility': 'Royan Institute', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Ashraf Moini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Endocrinology and Female Infertility Department, Reproductive Medicine Research Center, Royan institute, ACECR, Tehran, Iran'}, {'name': 'Marzieh Shiva, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Endocrinology and Female Infertility Department, Reproductive Medicine Research Center, Royan institute, ACECR, Tehran, Iran'}, {'name': 'Narges bagheri lankarani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Endocrinology and Female Infertility Department, Reproductive Medicine Research Center, Royan institute, ACECR, Tehran, Iran'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royan Institute', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Hamid Gourabi, Chief', 'oldOrganization': 'Royan Institute'}}}}