Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-02-26 @ 5:45 PM
Study NCT ID:
NCT02438735
Status:
COMPLETED
Last Update Posted:
2017-12-19
First Post:
2015-05-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endometrioma Related Reduced Ovarian Reserve
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum Anti-mullerian hormone (AMH)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-16', 'studyFirstSubmitDate': '2015-05-06', 'studyFirstSubmitQcDate': '2015-05-07', 'lastUpdatePostDateStruct': {'date': '2017-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Serum Anti- mullerian hormone (AMH) level', 'timeFrame': 'at recruitment and six months later'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ovarian endometriomas', 'AMH', 'ovarian reserve'], 'conditions': ['Endometriosis']}, 'referencesModule': {'references': [{'pmid': '23624580', 'type': 'BACKGROUND', 'citation': 'Uncu G, Kasapoglu I, Ozerkan K, Seyhan A, Oral Yilmaztepe A, Ata B. Prospective assessment of the impact of endometriomas and their removal on ovarian reserve and determinants of the rate of decline in ovarian reserve. Hum Reprod. 2013 Aug;28(8):2140-5. doi: 10.1093/humrep/det123. Epub 2013 Apr 26.'}, {'pmid': '29935810', 'type': 'DERIVED', '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': 'Prior studies have shown surgical excision of endometriomas are associated with a decline in ovarian reserve as assessed by serum anti-Mullerian Hormone (AMH) levels. However, the natural history of serum AMH levels in the presence of untreated endometriomas are unknown. Purpose of this study is to determine whether the presence of endometriomas cause a faster decline in serum AMH levels than in healthy women over a six months period.', 'detailedDescription': 'The study is a prospective cohort study. Women diagnosed with endometriomas by transvaginal or transabdominal ultrasound or MRI will be recruited from a tertiary care endometriosis clinic. Age matched healthy controls will be recruited from the staff of the same hospital. A priorly published historical group of women who underwent endometrioma excision will be a second comparator.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The decision to include a healthy control group was taken five months after starting recruitment of women with endometrioma. Only 12 women with endometriomas had been recruited until then and none of them had six month serum AMH level measured.\n\nSince healthy controls were reluctant to undergo transvaginal ultrasound examination, antral follicle counts were not measured as another marker of ovarian reserve for healthy controls and some women in the endometrioma group.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Reproductive age\n* Endometrioma without indication for surgery or treatment with combined contraceptive, progestin or other hormonal intervention.\n\nExclusion Criteria:\n\n* Menstrual cycle irregularity\n* Polycystic ovarian syndrome\n* Women who were pregnant or contemplating pregnancy in the next six months\n* History of ovarian surgery\n* Using medication which could affect ovarian function during six months before recruitment\n* Indication for surgical excision'}, 'identificationModule': {'nctId': 'NCT02438735', 'acronym': 'ERROR', 'briefTitle': 'Endometrioma Related Reduced Ovarian Reserve', 'organization': {'class': 'OTHER', 'fullName': 'Uludag University'}, 'officialTitle': 'The Effect Of The Presence Of Endometriomas On Ovarian Reserve', 'orgStudyIdInfo': {'id': '2015-7/12'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Endometrioma', 'description': 'Reproductive aged women diagnosed with endometrioma. Conservative follow up for six months.', 'interventionNames': ['Other: Conservative follow up']}, {'label': 'Healthy Controls', 'description': 'Women with regular menstrual cycles and without ovarian pathology will be recruited from physicians, nurses and other staff of the same hospital.\n\nControls will be matched for age with the women in the endometrioma group. They will be conservatively followed up for six months.', 'interventionNames': ['Other: Conservative follow up']}, {'label': 'Historical controls who underwent surgical excision', 'description': '20 women who underwent surgical excision of endometrioma in the same clinic had serum AMH levels measured preoperatively and on post operative sixth month. Their values will be compared with that of endometrioma group. These data were priorly published in detail (Uncu et al. 2013).', 'interventionNames': ['Procedure: laparoscopic endometrioma excision']}], 'interventions': [{'name': 'laparoscopic endometrioma excision', 'type': 'PROCEDURE', 'armGroupLabels': ['Historical controls who underwent surgical excision']}, {'name': 'Conservative follow up', 'type': 'OTHER', 'armGroupLabels': ['Endometrioma', 'Healthy Controls']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bursa', 'state': 'Turkey/bursa', 'country': 'Turkey (Türkiye)', 'facility': 'Uludag University Scholl of medicine', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}], 'overallOfficials': [{'name': 'gürkan uncu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Uludag University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uludag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'prof.md', 'investigatorFullName': 'GÜRKAN UNCU,PROF. MD', 'investigatorAffiliation': 'Uludag University'}}}}