Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-01-01 @ 5:33 AM
Study NCT ID:
NCT01919333
Status:
UNKNOWN
Last Update Posted:
2013-08-09
First Post:
2013-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-Mullerian Hormone Changes After Laparoscopic Ovarian Cystectomy for Endometrioma Compared With the Non-ovarian Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-05-26', 'releaseDate': '2016-04-20'}, {'resetDate': '2017-08-04', 'releaseDate': '2017-04-29'}], 'estimatedResultsFirstSubmitDate': '2016-04-20'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'lastUpdateSubmitDate': '2013-08-06', 'studyFirstSubmitDate': '2013-08-06', 'studyFirstSubmitQcDate': '2013-08-06', 'lastUpdatePostDateStruct': {'date': '2013-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum AMH levels', 'timeFrame': '6 months'}]}, 'conditionsModule': {'conditions': ['Ovarian Reserve']}, 'descriptionModule': {'briefSummary': 'This aim of the study is to evaluate the impact of endometrioma and laparoscopic cystectomy on ovarian reserve as measured by serum antimullerian hormone and to study the different effects of levels of serum antimullerian hormone between laparoscopic cystectomy and the non-ovarian pelvic surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Reproductive women , age 18- 45 years who undergo laparoscopic ovarian cystectomy or laparoscopic non- ovarian pelvic surgery', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* • Participants must be between the ages of 18 - 45 during enter the study .\n\n * Every participants have to completely understand the process of this study and have written informed consent .\n * Having regular menstrual cycles (21-35 days) at the time of operation\n * no evidence of any other endocrine disorders such as diabetes mellitus, thyroid dysfunction, hyperprolactinemia, congenital adrenal hyperplasia, Cushing's syndrome, or adrenal insufficiency.\n * undergo laparoscopic ovarian cystectomy or laparoscopic non- ovarian pelvic surgery for benign pelvic disease\n * No previous history of adnexal surgery\n * No any suspicious findings of malignant ovarian diseases\n * Never taking any medication such as oral pill and hormonal drugs within 3 months before the enrollment.\n * pathological diagnosis of excised ovarian tissue confirm as endometriotic cyst in study group and other benign pelvic disease in control group\n\nExclusion Criteria:\n\n* polycystic ovarian syndrome according to the Rotterdam criteria\n\n * pathological report as the malignant diseases\n * have operation conversion to open-laparotomy"}, 'identificationModule': {'nctId': 'NCT01919333', 'briefTitle': 'Anti-Mullerian Hormone Changes After Laparoscopic Ovarian Cystectomy for Endometrioma Compared With the Non-ovarian Conditions', 'organization': {'class': 'OTHER', 'fullName': 'Thammasat University'}, 'orgStudyIdInfo': {'id': 'MTU-OB-3-096/56'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'laparoscopic ovarian cystectomy', 'description': 'the group who laparoscopic ovarian cystectomy are performed for endometrioma'}, {'label': 'laparoscopic non- ovarian pelvic surgery', 'description': 'the group whom laparoscopic non- ovarian pelvic surgery are performed'}]}, 'contactsLocationsModule': {'locations': [{'zip': '12120', 'city': 'Rangsit City Municipality', 'state': 'Pathumthanee', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Chamnan Tanprasertkul', 'role': 'CONTACT', 'email': 'chamnandoctor@gmail.com', 'phone': '66896999240'}], 'facility': 'Faculty of medicine , Thammasat university', 'geoPoint': {'lat': 13.98333, 'lon': 100.61667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thammasat University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Chamnan Tanprasertkul', 'investigatorAffiliation': 'Thammasat University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-04-20', 'type': 'RELEASE'}, {'date': '2016-05-26', 'type': 'RESET'}, {'date': '2017-04-29', 'type': 'RELEASE'}, {'date': '2017-08-04', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Chamnan Tanprasertkul, Associate Professor, Thammasat University'}}}}