Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-03-05 @ 12:07 PM
Study NCT ID:
NCT02132559
Status:
COMPLETED
Last Update Posted:
2014-05-07
First Post:
2014-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Dehydroepiandrosterone Administration in Patients With Poor Ovarian Response According to the Bologna Criteria
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': 'D003687', 'term': 'Dehydroepiandrosterone'}], 'ancestors': [{'id': 'D000737', 'term': 'Androstenols'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D015068', 'term': '17-Ketosteroids'}, {'id': 'D007664', 'term': 'Ketosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045165', 'term': 'Testosterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 386}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-05', 'studyFirstSubmitDate': '2014-05-05', 'studyFirstSubmitQcDate': '2014-05-05', 'lastUpdatePostDateStruct': {'date': '2014-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ongoing pregnancy rates', 'timeFrame': '12 weeks after gestation.'}], 'secondaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '28 days after the embryo transfer'}, {'measure': 'the number of retrieved oocytes', 'timeFrame': '36-37 hrs after hCG administration'}, {'measure': 'Fertilization rate', 'timeFrame': 'on day 1 after oocyte retrieval'}, {'measure': 'Cleavage rate', 'timeFrame': 'on day 2 or 3 after oocyte retrieval'}, {'measure': 'Implantation rate', 'timeFrame': '28 days after the embryo transfer'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'Women with low ovarian reserve typically respond less well to the drugs used to stimulate the ovary during IVF treatment and produce fewer eggs and, as a result, are less likely to fall pregnant either naturally or after fertility treatment. The ideal stimulation regimen for poor responders is currently unknown.\n\nDehydroepiandrosterone (DHEA) has been reported to improve pregnancy chances for poor responders, and is now utilized by approximately one third of all IVF centers world-wide. However, the current clinical evidence for DHEA on improvement of ovarian response and IVF outcome is insufficient. The validity of the results of the former studies, especially the varied inclusion criteria used to specify poor responders, is a subject of debate. Recently a uniform definition on poor ovarian response, the Bologna criteria, has been proposed by the European Society for Human Reproduction and Embryology(ESHRE). However, no studies have been performed study to evaluate the potential effects of DHEA supplementation according to these standards.\n\nThe purpose of this study is to assess the impact of DHEA supplementation on IVF outcome of poor ovarian responders that fulfill the Bologna criteria.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '23 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients were stratified according to the Bologna criteria for poor ovarian response. Poor responders were classified with at least two of the three following criteria: (I) advanced maternal age (≥40 years) or any other risk factor for POR; (II) a previous POR(≤3 oocytes with a conventional ovarian stimulation protocol); and (III) an abnormal ovarian reserve test (ORT): antral follicle count (AFC) \\< 5-7 or serum anti-Mullerian hormone (AMH) \\<0.5-1.1 ng/mL, as described by the Bologna criteria', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with poor ovarian response according to the Bologna criteria\n\nExclusion Criteria:\n\nwomen aged \\> 45 years or baseline follicle stimulating hormone(FSH)levels \\>40 IU/l.'}, 'identificationModule': {'nctId': 'NCT02132559', 'briefTitle': 'Effect of Dehydroepiandrosterone Administration in Patients With Poor Ovarian Response According to the Bologna Criteria', 'organization': {'class': 'NETWORK', 'fullName': 'Chinese Medical Association'}, 'orgStudyIdInfo': {'id': 'NSFC30901601'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'DHEA administration,no treatment', 'description': 'The patients of study group received DHEA 25 mg orally,three times a day before the IVF cycle. Except for IVF, the control group of patients did not receive any pre-treatment.', 'interventionNames': ['Drug: DHEA']}], 'interventions': [{'name': 'DHEA', 'type': 'DRUG', 'otherNames': ['dehydroepiandrosterone'], 'armGroupLabels': ['DHEA administration,no treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Reproductive Medicine Center, Tongji Hospital, Tongji Medicine College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'overallOfficials': [{'name': 'Guijin Zhu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Reproductive Medicine Center, Tongji Hospital, Tongji Medicine College, Huazhong University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Medical Association', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}