Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-25 @ 2:02 PM
Study NCT ID:
NCT03476759
Status:
COMPLETED
Last Update Posted:
2021-11-29
First Post:
2018-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Tubal Adhesiolysis Versus IVF-ICSI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-26', 'studyFirstSubmitDate': '2018-03-18', 'studyFirstSubmitQcDate': '2018-03-22', 'lastUpdatePostDateStruct': {'date': '2021-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Affordability', 'timeFrame': 'Within 1year', 'description': 'Costs of each maneuver'}], 'primaryOutcomes': [{'measure': 'clinical pregnancy rate', 'timeFrame': 'After 1year', 'description': 'The number of pregnant women in both groups'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tubal Factor Infertility']}, 'descriptionModule': {'briefSummary': '2groups with peritoneal adhesions after cesarean delivery will be allocated to either laparoscopic tubal adhesiolysis or to IVF/ICSI', 'detailedDescription': "This randomized clinical trial will be conducted at Tanta university hospitals in fertility and MIS units. Two hundred and fifty 2ry infertility patients with confirmed post C.S adhesions will be included in the study and those patients will be divided randomly in two groups:\n\nGroup A:\n\n125 patients will be undergoing laparoscopic tubal adhesiolysis and\\\\or tuboplasty then a widow of 12 months post operatively is given for natural conception.\n\nGroup B:\n\n125 patients will undergo IVF-ICSI procedures. The primary outcome measure of the study will be the rate of clinical pregnancy.\n\nInclusion criteria:\n\n* patient's age not exceeding 35 years old\n* confirmed post caesarean section tubal adhesions (by diagnostic laparoscopy report or video CDs) as a solitary cause of their 2ry infertility.\n\nExclusion criteria:\n\n* patient's age \\>35 years\n* other causes of infertility as male factor contribution, any ovulatory or endocrinological disorder,\n* diagnosed any degree of endometriosis\n* patients with history of recurrent pregnancy loss.\n* couples with prolonged sexual abstinence for any reason Detailed explanation of the aims, procedures, steps and nature of the study for the participants will be done and a written consent will be signed by each patient before inclusion.\n\nAfter allocation laparoscopic tubal adhesions will be dissected and normal anatomy and function will be restored. In the other group IVF/ICSI will be commenced The follow up with both groups will extend to 1year or till pregnancy is aggrieved The outcomes of the study were pregnancy rates and affordability"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'females only', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age not exceeding 35 years old with confirmed post caesarean section tubal adhesions (by diagnostic laparoscopy report or video CDs) as a solitary cause of their 2ry infertility.\n\nExclusion Criteria:\n\n* patient's age \\>35 years, male factor contribution, any ovulatory or endocrinological disorder, diagnosed any degree of endometriosis and patients with history of recurrent pregnancy loss. Couples with prolonged sexual abstinence for any reason will be excluded from participation in the study."}, 'identificationModule': {'nctId': 'NCT03476759', 'briefTitle': 'Laparoscopic Tubal Adhesiolysis Versus IVF-ICSI', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Laparoscopic Tubal Adhesiolysis Versus IVF-ICSI in Cases of Post Caesarean Section Adhesions, Which is the Best?', 'orgStudyIdInfo': {'id': 'Tanta University'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tubal adhesiolysis', 'description': 'laparoscopic tubal adhesiolysis and\\\\or tuboplasty', 'interventionNames': ['Procedure: Tubal adhesiolysis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IVF/ICSI', 'description': 'These patients will undergo IVF/ICSI', 'interventionNames': ['Drug: IVF/ICSI']}], 'interventions': [{'name': 'Tubal adhesiolysis', 'type': 'PROCEDURE', 'description': '125 patients will undergo tubal adhesiolysis or tuboplasty', 'armGroupLabels': ['Tubal adhesiolysis']}, {'name': 'IVF/ICSI', 'type': 'DRUG', 'description': '125 patients will undergo IVF-ICSI procedures.', 'armGroupLabels': ['IVF/ICSI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31111', 'city': 'Tanta', 'state': 'Algharbia', 'country': 'Egypt', 'facility': 'Ayman Shehata Dawood', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'Ayman Dawood, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer at Tanta University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'yes'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ayman S Dawood, MD', 'investigatorAffiliation': 'Tanta University'}}}}