Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT04058912
Status:
UNKNOWN
Last Update Posted:
2019-08-16
First Post:
2019-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PTEN-AKT-FOXO3 Gene Expression Relation With Low-ovarian Reserve in Endometriomas
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': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-14', 'studyFirstSubmitDate': '2019-08-14', 'studyFirstSubmitQcDate': '2019-08-14', 'lastUpdatePostDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PTEN AKT FOXO3 gene expression', 'timeFrame': '30 minutes', 'description': 'In the patient and patient control groups, 0.5 mm tissue strip will be removed for pathology from the cyst wall removed during surgery. and tissue samples will be stored in phosphate buffered saline at -80 C and PTEN-AKT-FOXO3 gene expression level will be evaluated by RT-PCR analysis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ovarian Reserve, Endometrioma, PTEN-AKT-FOXO3 Gene Expression']}, 'referencesModule': {'references': [{'pmid': '24154570', 'type': 'BACKGROUND', 'citation': 'Govatati S, Kodati VL, Deenadayal M, Chakravarty B, Shivaji S, Bhanoori M. Mutations in the PTEN tumor gene and risk of endometriosis: a case-control study. Hum Reprod. 2014 Feb;29(2):324-36. doi: 10.1093/humrep/det387. Epub 2013 Oct 23.'}, {'pmid': '29935810', 'type': 'BACKGROUND', 'citation': 'Kasapoglu I, Ata B, Uyaniklar O, Seyhan A, Orhan A, Yildiz Oguz S, Uncu G. Endometrioma-related reduction in ovarian reserve (ERROR): a prospective longitudinal study. Fertil Steril. 2018 Jul 1;110(1):122-127. doi: 10.1016/j.fertnstert.2018.03.015. Epub 2018 Jun 20.'}]}, 'descriptionModule': {'briefSummary': 'In this study, we aimed to investigate the relationship between PTEN-AKT-FOXO3 gene expression and decrease in ovarian reserve in the presence of endometrioma and other benign ovarian pathologies.', 'detailedDescription': 'It is known that the presence of endometrioma negatively affects ovarian reserve. The development of endometriosis and the effect of the presence of endometrioma on ovarian reserve due to decreased PTEN expression are considered. This study was designed to compare ovarian PTEN-AKT-FOXO3 gene expression and ovarian reserve in patients with underwent surgery caused by endometrioma and those who had ovarian pathology due to other benign causes and PTEN-AKT-FOXO3 gene expression level will be evaluated by RT-PCR analysis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is the patients examined for ovarian endometriomas and other benign ovarian pathologies', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\) To be in the range of 18-40 years 2) Patients with an operation indication with \\>=5 cm endometrioma 3) Patients with operation plan due to non-endometrioma ovarian pathologies\n\nExclusion Criteria:\n\n* 1)Patients over the age of 40 2)Patients with suspected malignancy 3)Follow-up patients without indications for operation'}, 'identificationModule': {'nctId': 'NCT04058912', 'briefTitle': 'PTEN-AKT-FOXO3 Gene Expression Relation With Low-ovarian Reserve in Endometriomas', 'organization': {'class': 'OTHER', 'fullName': 'Uludag University'}, 'officialTitle': 'RELATIONSHIP OF LOW-OVER RESERVE WITH PTEN-AKT-FOXO3 GENE EXPRESSION IN THE PRESENCE OF ENDOMETRIOMAS', 'orgStudyIdInfo': {'id': 'UU-MREC-2019-5/28'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PATİENCE GROUP', 'description': '1. To be in the range of 18-40 years\n2. Patients with an operation indication with \\>=5 cm endometrioma\n\n 1. Symptomatic patients due to endometrioma (dysmenorrhea, dyspareunia, chronic pelvic pain, etc.)\n 2. Patients who will be followed for IVF cycle due to infertility', 'interventionNames': ['Genetic: PTEN-AKT-FOXO3 Gene Expression']}, {'label': 'PATİENCE-CONTROL GROUP', 'description': '1. To be in the range of 18-40 years\n2. Patients with operation plan due to non-endometrioma ovarian pathologies\n\n 1. Symptomatic patients with benign ovarian pathology (such as chronic pelvic pain, compression, syphilomas, dysmenorrhea, dyspareunia, etc.)\n 2. Asymptomatic, despite a 6-month follow-up period, increase in cyst size or become symptomatic', 'interventionNames': ['Genetic: PTEN-AKT-FOXO3 Gene Expression']}], 'interventions': [{'name': 'PTEN-AKT-FOXO3 Gene Expression', 'type': 'GENETIC', 'description': 'In the patient and patient control groups, 0.5 mm tissue strip will be removed for pathology from the cyst wall removed during surgery. and tissue samples will be stored in phosphate buffered saline at -80 C and PTEN-AKT-FOXO3 gene expression level will be evaluated by RT-PCR analysis.', 'armGroupLabels': ['PATİENCE GROUP', 'PATİENCE-CONTROL GROUP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16059', 'city': 'Bursa', 'state': 'Nilufer', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'HAMZA F SEN, MD', 'role': 'CONTACT', 'email': 'hamzafurkansen@yahoo.com', 'phone': '+90 5443939159'}, {'name': 'Isil Kasapoglu, MD', 'role': 'CONTACT', 'email': 'kasapogluisil@hotmail.com', 'phone': '+905305455848'}], 'facility': 'Uludag University Hospital, Department of Obstetrics and Gynecology', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}, {'zip': '16059', 'city': 'Bursa', 'state': 'Nilufer', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'H.FURKAN MD SEN', 'role': 'CONTACT', 'email': 'hamzafurkansen@yahoo.com', 'phone': '+90 5443939159'}, {'name': 'Isil MD Kasapoglu', 'role': 'CONTACT', 'email': 'kasapogluisil@hotmail.com', 'phone': '+905305455848'}], 'facility': 'Uludag University Hospital, Department of Obstetrics and Gynecology', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}], 'centralContacts': [{'name': 'HAMZA F SEN, MD', 'role': 'CONTACT', 'email': 'hamzafurkansen@yahoo.com', 'phone': '+90 544 3939159'}, {'name': 'Isil Kasapoglu, MD', 'role': 'CONTACT', 'email': 'kasapogluisil@hotmail.com', 'phone': '+905305455848'}], 'overallOfficials': [{'name': 'GURKAN UNCU, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ULUDAG UNIVERSITY HOSPITAL BURSA TURKEY'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uludag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': ': Principal Investigator. Professor, Obstetrician and Gynecologist', 'investigatorFullName': 'GÜRKAN UNCU,PROF. MD', 'investigatorAffiliation': 'Uludag University'}}}}