Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2026-01-05 @ 5:20 PM
Study NCT ID:
NCT02293668
Status:
COMPLETED
Last Update Posted:
2016-01-08
First Post:
2014-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome of Three Controlled Ovarian Hyperstimulation Protocols in Poor Responding Infertility Patients
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': 'D000077289', 'term': 'Letrozole'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-07', 'studyFirstSubmitDate': '2014-11-14', 'studyFirstSubmitQcDate': '2014-11-17', 'lastUpdatePostDateStruct': {'date': '2016-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Number of oocytes retrieved', 'timeFrame': '4 weeks'}, {'measure': 'Number of transferable embryos', 'timeFrame': '4 weeks'}, {'measure': 'Biochemical pregnancy rate', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['poor responders'], 'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '21505041', 'type': 'BACKGROUND', 'citation': "Ferraretti AP, La Marca A, Fauser BC, Tarlatzis B, Nargund G, Gianaroli L; ESHRE working group on Poor Ovarian Response Definition. ESHRE consensus on the definition of 'poor response' to ovarian stimulation for in vitro fertilization: the Bologna criteria. Hum Reprod. 2011 Jul;26(7):1616-24. doi: 10.1093/humrep/der092. Epub 2011 Apr 19."}]}, 'descriptionModule': {'briefSummary': 'There are different controlled ovarian hyperstimulation protocols utilized in infertility patients. In this study, our aim is to specifically compare three protocols in poor responding infertility patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients will be considered eligible if they are poor ovarian responders according to the Bologna criteria (Ferraretti et al., 2011).\n* Two out of three of the following criteria are essential in order to classify a patient as poor ovarian responder:\n\n * advanced maternal age (≥40 years) or any other risk factor for poor ovarian response;\n * a poor ovarian response (≤3 oocytes with a conventional stimulation protocol); or\n * an abnormal ovarian reserve test (antral follicle count, \\<7 follicles or anti-Mullerian hormone, \\<1.1 ng/ml).'}, 'identificationModule': {'nctId': 'NCT02293668', 'briefTitle': 'Outcome of Three Controlled Ovarian Hyperstimulation Protocols in Poor Responding Infertility Patients', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'orgStudyIdInfo': {'id': '1001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Combined 450', 'description': 'Recombinant FSH 225IU/day and human menopausal gonadotropin (hMG) 225IU/day will be initiated on the second or third day of spontaneous menstruation and continued until the day of ovulation triggering. Ovulation triggering will be performed with the administration of 10000IU of human chorionic gonadotropin (hCG) as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound.', 'interventionNames': ['Drug: FSH 225IU and hMG 225IU']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Combined 300', 'description': 'Recombinant FSH 150IU/day and human menopausal gonadotropin (hMG) 150IU/day will be initiated on the second or third day of spontaneous menstruation and continued until the day of ovulation triggering. Ovulation triggering will be performed with the administration of 10000IU of human chorionic gonadotropin (hCG) as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound.', 'interventionNames': ['Drug: FSH 150IU and hMG 150IU']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Letrozole and hMG', 'description': 'Letrozole (Femara; Novartis, East Hanover, NJ) at a dose of 5 mg/day and human menopausal gonadotropin (hMG) 150IU/day will be initiated on the second or third day of spontaneous menstruation and continued until the day of ovulation triggering. Ovulation triggering will be performed with the administration of 10000 IU of human chorionic gonadotropin (hCG) as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound.', 'interventionNames': ['Drug: Letrozole 5mg and hMG 150IU']}], 'interventions': [{'name': 'FSH 225IU and hMG 225IU', 'type': 'DRUG', 'armGroupLabels': ['Combined 450']}, {'name': 'FSH 150IU and hMG 150IU', 'type': 'DRUG', 'armGroupLabels': ['Combined 300']}, {'name': 'Letrozole 5mg and hMG 150IU', 'type': 'DRUG', 'armGroupLabels': ['Letrozole and hMG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34093', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University School of Medicine', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Obstetrics and Gynecology', 'investigatorFullName': 'Ercan Bastu', 'investigatorAffiliation': 'Istanbul University'}}}}