Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-01-05 @ 5:53 PM
Study NCT ID:
NCT06471166
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Different Treatment Modalities of Tubal Ectopic Pregnancy on Ovarian Reserve: a Prospective Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011271', 'term': 'Pregnancy, Ectopic'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-18', 'studyFirstSubmitDate': '2024-06-18', 'studyFirstSubmitQcDate': '2024-06-18', 'lastUpdatePostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in levels of AMH pre and post treatment', 'timeFrame': '3 months'}]}, 'conditionsModule': {'conditions': ['Ectopic Pregnancy']}, 'descriptionModule': {'briefSummary': 'Detect the effect of different treatment modalities of tubal ectopic pregnancy on ovarian reserve'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Women's Health Hospital, Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University", 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The study will include patients aged 18-44 years with known diagnosis or suspicion of diagnosis of tubal ectopic pregnancy (abnormal doubling rates of their b-HCG levels as well as ultrasonographically identified or unidentified gestational sacs outside the uterus)\n* Included patients must have capacity to provide informed consent. Given the potential emergent nature of presentation, women will not be recruited if fully informed consent could be compromised due to a highly distressed emotional state or significant hemorrhage necessitating the need for urgent surgery\n\nExclusion Criteria:\n\n1. The use of hormonal contraceptives within two months of enrolment\n2. If other surgery was conducted at the time of salpingectomy.\n3. If a woman was pregnant at follow up visit for AMH measurement\n4. History of previous surgeries of fallopian tubes and/or ovaries'}, 'identificationModule': {'nctId': 'NCT06471166', 'briefTitle': 'The Effect of Different Treatment Modalities of Tubal Ectopic Pregnancy on Ovarian Reserve: a Prospective Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Effect of Different Treatment Modalities of Tubal Ectopic Pregnancy on Ovarian Reserve: a Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'Ectopic pregnancy'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Conservative management', 'interventionNames': ['Diagnostic Test: Amh hormone']}, {'label': 'Medical treatment', 'interventionNames': ['Diagnostic Test: Amh hormone']}, {'label': 'Surgical treatment (Open or laparoscopic salpingectomy)', 'interventionNames': ['Diagnostic Test: Amh hormone']}, {'label': 'Surgical treatment after failed medical treatment (Open or laparoscopic salpingectomy)', 'interventionNames': ['Diagnostic Test: Amh hormone']}, {'label': 'Conservative surgical treatment (salpingotomy, salpingostomy, tubal milking)', 'interventionNames': ['Diagnostic Test: Amh hormone']}, {'label': 'Conservative surgical treatment after failed medical treatment', 'interventionNames': ['Diagnostic Test: Amh hormone']}], 'interventions': [{'name': 'Amh hormone', 'type': 'DIAGNOSTIC_TEST', 'description': 'Ovarian reserve', 'armGroupLabels': ['Conservative management', 'Conservative surgical treatment (salpingotomy, salpingostomy, tubal milking)', 'Conservative surgical treatment after failed medical treatment', 'Medical treatment', 'Surgical treatment (Open or laparoscopic salpingectomy)', 'Surgical treatment after failed medical treatment (Open or laparoscopic salpingectomy)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Andro Bahgat, Md', 'role': 'CONTACT'}], 'facility': 'Assiut university', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Andro Bahgat, MD', 'role': 'CONTACT', 'email': 'androbahgat7@gmail.com', 'phone': '01283104773'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Andro Bahgat Heshmat', 'investigatorAffiliation': 'Assiut University'}}}}