Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2026-02-25 @ 6:55 PM
Study NCT ID:
NCT03220594
Status:
COMPLETED
Last Update Posted:
2017-10-02
First Post:
2017-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serum AMH Levels in Patients Who Underwent Hypogastric Artery Ligation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007044', 'term': 'Hysterectomy'}], 'ancestors': [{'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-29', 'studyFirstSubmitDate': '2017-07-14', 'studyFirstSubmitQcDate': '2017-07-14', 'lastUpdatePostDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ovarian reserve', 'timeFrame': '6 months', 'description': 'To evaluate postoperative ovarian reserve using anti-mullerian hormones and other ovary related hormones including FSH,LH'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypogastric artery', 'anti-mullerian hormone', 'ovarian reserve', 'postpartum'], 'conditions': ['AMH']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/22268398', 'label': 'The effect of total abdominal hysterectomy on serum anti-Müllerian hormone levels: a pilot study'}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/20128664', 'label': 'Effect of internal iliac artery ligation on ovarian blood supply and ovarian reserve'}]}, 'descriptionModule': {'briefSummary': 'To observe the effects of hypogastric artery ligation on serum antimullerian hormone levels.', 'detailedDescription': 'To measure and compare serum antimullerian hormone levels in patients who underwent hypogastric artery ligation/ hypogastric artery ligation+ hysterectomy and postpartum control. The procedures performed as an emergency life saving method during delivery. The reasons for hypogastric artery ligation/ hypogastric artery ligation+ hysterectomy were obstetric hemorrhage mainly uterine atony.\n\nThe serum levels of antimullerian hormone were measured 6 months after the operations and compared with matching postpartum controls. Serum levels of FSH, LH, PRL and TSH were also measured 6 months after the operation. Further, antral follicle count measured along with the aforementioned blood tests.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who had hypogastric artery ligation and/or hysterectomy during their delivery. Control group is age-matched postpartum patients.', 'genderDescription': 'All participants are females undergoing delivery of their baby', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18- 40 years\n* no systemic or endocrine diseases\n* patients who had hypogastric artery ligation and/or hysterectomy\n* healthy postpartum patients as controls\n\nExclusion Criteria:\n\n* history of chemotherapy and/or radiotherapy\n* Obese patients\n* patients with previous/present endometriosis\n* patients with PCOS'}, 'identificationModule': {'nctId': 'NCT03220594', 'briefTitle': 'Serum AMH Levels in Patients Who Underwent Hypogastric Artery Ligation', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'Serum Antimullerian Hormone Levels in Patients Who Underwent Hypogastric Artery Ligation', 'orgStudyIdInfo': {'id': '1826'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hypogastric artery ligation (HAL)', 'description': 'Patients who underwent only hypogastric artery ligation performed during the delivery of their babies. Six months after the operation they will evaluated for their ovarian reserve via hormones and astral follicle count (AFC)', 'interventionNames': ['Procedure: hypogastric artery ligation']}, {'label': 'HAL and hysterectomy', 'description': 'Patients who underwent both hypogastric artery ligation and hysterectomy performed during the delivery of their babies. Six months after the operation they will evaluated for their ovarian reserve via hormones and astral follicle count (AFC)', 'interventionNames': ['Procedure: hypogastric artery ligation']}, {'label': 'Postpartum', 'description': 'Postpartum control group constituted of patients delivered baby without any complication and evaluated 6 months later.'}], 'interventions': [{'name': 'hypogastric artery ligation', 'type': 'PROCEDURE', 'otherNames': ['hysterectomy'], 'description': "hypogastric artery ligation is the ligation of the internal iliac artery to stop bleeding related to obstetrics obstetric hemorrhage Hysterectomy is the removal of the uterus if bleeding can't stop by hypogastric artery ligation", 'armGroupLabels': ['HAL and hysterectomy', 'Hypogastric artery ligation (HAL)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34303', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Kanuni SSTRH', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Alev Atıs, MD,ObGyn', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD,ObGYN', 'investigatorFullName': 'Berna Aslan Cetin', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}