Ignite Creation Date:
2025-12-24 @ 12:32 PM
Ignite Modification Date:
2025-12-27 @ 11:53 PM
Study NCT ID:
NCT01268761
Status:
COMPLETED
Last Update Posted:
2013-09-19
First Post:
2010-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GnRH Antagonist for Treatment of Early 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': 'C062876', 'term': 'cetrorelix'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-18', 'studyFirstSubmitDate': '2010-12-23', 'studyFirstSubmitQcDate': '2010-12-30', 'lastUpdatePostDateStruct': {'date': '2013-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ultrasound', 'timeFrame': 'one week', 'description': 'Ultrasound measurements: ascitis and ovarian size'}, {'measure': 'Blood measurements', 'timeFrame': 'one week', 'description': 'Blood measurements: hyperstimulation biomarkers, liver and kidney function and hormonal profile.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ovarian hyperstimulation syndrome (OHSS)', 'GnRH antagonist', 'Ascitis.'], 'conditions': ['Ovarian Hyperstimulation Syndrome', 'Effects of Gonadotropin', 'Oocyte Maturation']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to analyze the effectiveness of GnRh antagonist in the treatment of early ovarian hyperstimulation syndrome.', 'detailedDescription': 'Ovarian hyperstimulation syndrome (OHSS) is a serious complication of ovarian stimulation protocols. Gonadotrophin-releasing hormone (GnRH) antagonist administration in the luteal phase was recently proposed as a new approach for the management of patients with established severe OHSS We analyze the response of egg donors with moderate- severe early ovarian hyperstimulation syndrome after a GnRH antagonist stimulation protocol to the administration of a daily doses of GnRH antagonist (Cetrorelix 0.25) during 7 days after the second day of oocyte retrieval compared with placebo (saline solution).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Egg donors\n* Volunteers.\n* 18-35 years old\n* Healthy\n* BMI \\< 30\n* OHHS after oocyte retrieval defined as ascitis \\> 9 cm2 associate to abdominal pain, sickness, abdominal distention,or haematocrit (Ht) \\>45% an white blood cell count \\>15,000/mm3 or creatine \\> 1.2 mg/dl or transaminases \\> 40 IU/liter\n\nExclusion Criteria:\n\n* BMI \\> 30\n* Allergy to GnRH antagonist'}, 'identificationModule': {'nctId': 'NCT01268761', 'briefTitle': 'GnRH Antagonist for Treatment of Early Ovarian Hyperstimulation Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Valenciano de Infertilidad, IVI VALENCIA'}, 'officialTitle': 'Usefulness of GnRH Antagonist Administration in the Treatment of Early Ovarian Hyperstimulation Syndrome', 'orgStudyIdInfo': {'id': '0810-C-052-JG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GnRH antagonist', 'description': '• GnRH antagonist (Cetrorelix 0.25)', 'interventionNames': ['Drug: GnRH antagonist (Cetrorelix)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (saline solution)', 'description': '• Placebo (saline solution)', 'interventionNames': ['Drug: Placebo (saline solution)']}], 'interventions': [{'name': 'GnRH antagonist (Cetrorelix)', 'type': 'DRUG', 'description': '•GnRH antagonist (Cetrorelix 0.25) during 7 days beginning administration the second day of oocyte retrieval', 'armGroupLabels': ['GnRH antagonist']}, {'name': 'Placebo (saline solution)', 'type': 'DRUG', 'description': '• Placebo (saline solution) 1 ampoule every 24 hours during 7 days beginning administration the second day of oocyte retrieval', 'armGroupLabels': ['Placebo (saline solution)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46015', 'city': 'Valencia', 'country': 'Spain', 'facility': 'IVI Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Juan Giles, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IVI Valencia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Valenciano de Infertilidad, IVI VALENCIA', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator; Gynecologist IVI Valencia', 'investigatorFullName': 'Juan Giles', 'investigatorAffiliation': 'Instituto Valenciano de Infertilidad, IVI VALENCIA'}}}}