Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2026-02-20 @ 10:08 PM
Study NCT ID:
NCT06903650
Status:
COMPLETED
Last Update Posted:
2025-04-03
First Post:
2025-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Salpingectomy Operation on Ovarian Reserve
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2021-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2025-03-21', 'studyFirstSubmitQcDate': '2025-03-28', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'right ovarian arter pı', 'timeFrame': 'perioperative, postoperative days 2 , postoperative weeks 6', 'description': 'rate of 0,87/ 0,84/ 0,76'}, {'measure': 'left ovarian arter pı', 'timeFrame': 'perioperative, postoperative days 2, postoperative weeks 6', 'description': 'rate of 0,89/ 0,79/ 0.80'}, {'measure': 'AMH levels', 'timeFrame': 'perioperative-postoperative weeks 6', 'description': 'Concentration of 1 ng/mL / 0,79 ng/mL'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Salpingectomy', 'Ovarian Reserve', 'Anti-Mullerian Hormone', 'Doppler Ultrasonography'], 'conditions': ['Ovarian Insufficiency']}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate the effect of salpingectomy operation on ovarian reserve. Ovarian reserve was evaluated by measuring anti-mullerian hormone levels from serum samples taken from the patients before the operation and 6 weeks after the operation. Ovarian doppler flow were evaluated by measuring the ovarian artery pulsatility index with transvaginal ultrasonography preoperatively, postoperative days 2 and postoperative weeks 6 . In our study, it was determined that ovarian functions may be negatively affected in the acute period after salpingectomy operation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '37 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Serum samples will be separated from routine blood samples taken from patients who apply to the outpatient clinic and will undergo salpingectomy within the indication, during perioperative preparation and at the 6th week postoperatively, after patient consent is obtained. This serum sample will be taken into an Eppendorf tube and kept at -40˚C for later AMH levels to be studied. Ovarian artery pulsatility index values measured during the patient's perioperative and postoperative routine ultrasonographic examination and weeks 6 postoperative control will be recorded.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women between the ages of 37-45 with continuing menstrual cycles (37 and 45 included)\n2. Patients who will undergo uterine surgery for benign reasons or who will undergo salpingectomy only due to hydrosalpinx, ectopic pregnancy, tubo-ovarian abscess\n3. Patients who have not had ovarian surgery before\n4. Those without menopause and premature ovarian failure\n5. Patients who accept the study\n\nExclusion Criteria:\n\n1. Age younger than 37 or older than 45\n2. Those who want to withdraw from the study\n3. Those who do not come for follow-up examination\n4. Use of drugs that affect ovarian reserve\n5. Any surgical procedure performed on the ovaries during the operation\n6. No menstrual bleeding in the last year\n7. Patients who received radiotherapy and hormonal therapy within 3 months before surgery'}, 'identificationModule': {'nctId': 'NCT06903650', 'briefTitle': 'The Effect of Salpingectomy Operation on Ovarian Reserve', 'organization': {'class': 'OTHER', 'fullName': 'Dokuz Eylul University'}, 'officialTitle': 'Evaluation of the Effect of Salpingectomy Operation on Ovarian Reserve With Anti-Mullerian Hormone and Ovarian Doppler Ultrasonography', 'orgStudyIdInfo': {'id': 'SOORAMHODU'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'perioperative ovarian arter pulsatility index(PI)(right and left), perioperative AMH levels', 'interventionNames': ['Procedure: bilateral salpingectomy, ovarian arter doppler ultrasonography']}, {'label': 'postoperative days 2 ovarian arter pulsatility index (PI) (right and left)', 'interventionNames': ['Procedure: bilateral salpingectomy, ovarian arter doppler ultrasonography']}, {'label': 'postop. weeks 6 ovarian arter pulsatility index(PI)(right and left), postop. weeks 6 AMH levels', 'interventionNames': ['Procedure: bilateral salpingectomy, ovarian arter doppler ultrasonography']}], 'interventions': [{'name': 'bilateral salpingectomy, ovarian arter doppler ultrasonography', 'type': 'PROCEDURE', 'description': 'The effect of salpingectomy operation on ovarian reserve', 'armGroupLabels': ['perioperative ovarian arter pulsatility index(PI)(right and left), perioperative AMH levels', 'postop. weeks 6 ovarian arter pulsatility index(PI)(right and left), postop. weeks 6 AMH levels', 'postoperative days 2 ovarian arter pulsatility index (PI) (right and left)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35000', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Dokuz Eylul University School of Medicine', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dokuz Eylul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Derya Öztürk', 'investigatorAffiliation': 'Dokuz Eylul University'}}}}