Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2026-01-03 @ 6:54 PM
Study NCT ID:
NCT03352661
Status:
UNKNOWN
Last Update Posted:
2017-11-24
First Post:
2017-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of an Endometrioma on Oocyte Quality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-20', 'studyFirstSubmitDate': '2017-01-17', 'studyFirstSubmitQcDate': '2017-11-20', 'lastUpdatePostDateStruct': {'date': '2017-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of mature oocytes', 'timeFrame': 'Up to 36 months', 'description': 'Number of MII oocytes from the total of cumulus granulosa cell-oocyte complex by 100'}, {'measure': 'Fertilization rate', 'timeFrame': 'Up to 36 months', 'description': 'Number of oocytes with pronuclear activation after ICSI procedure from the total oocytes microinjected by 100'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Endometriosis']}, 'referencesModule': {'references': [{'pmid': '15136074', 'type': 'BACKGROUND', 'citation': 'Garcia-Velasco JA, Mahutte NG, Corona J, Zuniga V, Giles J, Arici A, Pellicer A. Removal of endometriomas before in vitro fertilization does not improve fertility outcomes: a matched, case-control study. Fertil Steril. 2004 May;81(5):1194-7. doi: 10.1016/j.fertnstert.2003.04.006.'}, {'pmid': '10711831', 'type': 'BACKGROUND', 'citation': 'Garrido N, Navarro J, Remohi J, Simon C, Pellicer A. Follicular hormonal environment and embryo quality in women with endometriosis. Hum Reprod Update. 2000 Jan-Feb;6(1):67-74. doi: 10.1093/humupd/6.1.67.'}, {'pmid': '24602751', 'type': 'BACKGROUND', 'citation': 'Filippi F, Benaglia L, Paffoni A, Restelli L, Vercellini P, Somigliana E, Fedele L. Ovarian endometriomas and oocyte quality: insights from in vitro fertilization cycles. Fertil Steril. 2014 Apr;101(4):988-93.e1. doi: 10.1016/j.fertnstert.2014.01.008. Epub 2014 Mar 3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate if there are differences in oocyte quality depending on whether these oocytes come from an ovary in contact with an endometrioma.', 'detailedDescription': 'There is no consensus for whether an endometrioma influences oocyte quality, as well as the possible mechanisms that induce them.\n\nIn this study, the oocyte maturation will proof oocyte quality: This mean, the percentage of oocytes in metaphase II obtained after stimulation, as well as the rate of oocytes fertilized in direct contact with an endometrioma.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '25 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients \\<40 years, BMI \\<30kg / m2,', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\<40 years, BMI \\<30kg / m2,\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03352661', 'acronym': 'ENDOVOC', 'briefTitle': 'Influence of an Endometrioma on Oocyte Quality', 'organization': {'class': 'OTHER', 'fullName': 'IVI Vigo'}, 'officialTitle': 'Influence of an Endometrioma on Oocyte Quality', 'orgStudyIdInfo': {'id': '1311-VGO-137-EM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Endometriosis', 'description': 'No drugs are administered. It is an observational study. Collect retrospectively data', 'interventionNames': ['Other: Collect retrospectively data']}, {'label': 'No endometriosis', 'description': 'No drugs are administered. It is an observational study. Collect retrospectively data', 'interventionNames': ['Other: Collect retrospectively data']}], 'interventions': [{'name': 'Collect retrospectively data', 'type': 'OTHER', 'description': 'Collect retrospectively data', 'armGroupLabels': ['Endometriosis', 'No endometriosis']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Elkin Muñoz, Principal Investigator', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IVI Vigo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IVI Vigo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}