Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2026-01-01 @ 5:16 PM
Study NCT ID:
NCT01948804
Status:
UNKNOWN
Last Update Posted:
2014-01-15
First Post:
2013-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Comparison of Effect of Four Different Treatment Protocols on IVF Outcomes in Poor Responders Undergoing in Vitro Fertilization.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C062876', 'term': 'cetrorelix'}, {'id': 'D000077289', 'term': 'Letrozole'}, {'id': 'D016729', 'term': 'Leuprolide'}, {'id': 'C571801', 'term': 'follitropin alfa'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'lastUpdateSubmitDate': '2014-01-14', 'studyFirstSubmitDate': '2013-09-06', 'studyFirstSubmitQcDate': '2013-09-18', 'lastUpdatePostDateStruct': {'date': '2014-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical pregnancy rates', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'total number of oocytes retrieved', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Poor Responders Undergoing IVF']}, 'descriptionModule': {'briefSummary': 'The comparison of effect of four different treatment protocols: Antagonist/letrozole protocol, microdose flare-up protocol, Antagonist/clomiphene protocol, Antagonist on IVF outcomes in poor responders undergoing in vitro fertilization; a prospective randomized-controlled study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCriteria for definition of poor responders included at least one of the following\n\n1. Anti müllerian hormone \\<1.1 ng/ml and/or a previous poor ovarian response (≤3 oocytes with a conventional stimulation protocol).\n2. Primary infertile patients\n3. BMI≤30 kg/m2 were included this study.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01948804', 'briefTitle': 'The Comparison of Effect of Four Different Treatment Protocols on IVF Outcomes in Poor Responders Undergoing in Vitro Fertilization.', 'organization': {'class': 'OTHER', 'fullName': 'Yeditepe University Hospital'}, 'officialTitle': 'The Comparison of Effect of Four Different Treatment Protocols: Antagonist/Letrozole Protocol, Microdose Flare-up Protocol, Antagonist/Clomiphene Protocol, Antagonist on IVF Outcomes in Poor Responders Undergoing in Vitro Fertilization; a Prospective Randomized-controlled Study.', 'orgStudyIdInfo': {'id': 'ytu-123'}, 'secondaryIdInfos': [{'id': 'ytu-123', 'type': 'OTHER', 'domain': 'YeditepeUH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IVF patients', 'description': 'patients that has applied to Yeditepe University Hospital assisted reproduction center', 'interventionNames': ['Drug: GnrH Antagonist/letrozole protocol (Cetrotide; serono + Femara; Novartis Pharma AG)', 'Drug: microdose flare-up protocol (Lucrin; Abbott + Gonal F, Serono)', 'Drug: Antagonist/clomiphene protocol (Cetrotide; serono + Klomen, Kocak pharma)', 'Drug: GnRH antagonist protocol (Cetrotide, Serono)']}], 'interventions': [{'name': 'GnrH Antagonist/letrozole protocol (Cetrotide; serono + Femara; Novartis Pharma AG)', 'type': 'DRUG', 'armGroupLabels': ['IVF patients']}, {'name': 'microdose flare-up protocol (Lucrin; Abbott + Gonal F, Serono)', 'type': 'DRUG', 'armGroupLabels': ['IVF patients']}, {'name': 'Antagonist/clomiphene protocol (Cetrotide; serono + Klomen, Kocak pharma)', 'type': 'DRUG', 'armGroupLabels': ['IVF patients']}, {'name': 'GnRH antagonist protocol (Cetrotide, Serono)', 'type': 'DRUG', 'armGroupLabels': ['IVF patients']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pınar Özcan Cenksoy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Pınar Özcan Cenksoy', 'investigatorAffiliation': 'Yeditepe University Hospital'}}}}