Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-01 @ 4:18 AM
Study NCT ID:
NCT04580056
Status:
UNKNOWN
Last Update Posted:
2020-10-08
First Post:
2020-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hysteroscopy With Fundus Uterus Scratching Incision VS Office Hysteroscopy Before ET With Donor Eggs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-02', 'studyFirstSubmitDate': '2020-10-02', 'studyFirstSubmitQcDate': '2020-10-02', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implantation Rate', 'timeFrame': '6 weeks to 42 weeks after embryo transfer]', 'description': 'Implantation rate'}, {'measure': 'Delivery Rate', 'timeFrame': '6 weeks to 42 weeks after embryo transfer]', 'description': 'Delivery Rate'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hysteroscopy', 'Fundus Endometrial Incision', 'Oocyte acceptors', 'pregnancy outcome', 'uterine scratching'], 'conditions': ['Hysteroscopy, Oocyte Recipients']}, 'referencesModule': {'references': [{'pmid': '39033364', 'type': 'DERIVED', 'citation': 'Peitsidis N, Tsakiridis I, Najdecki R, Michos G, Kalogiannidis I, Athanasiadis A, Papanikolaou E. Hysteroscopic Endometrial Fundal Incision versus Hysteroscopy Only in Oocyte Recipients: A Randomized Controlled Trial Assessing The Reproductive Outcomes. Int J Fertil Steril. 2024 Jul 13;18(Suppl 1):3-9. doi: 10.22074/ijfs.2024.2009369.1523.'}]}, 'descriptionModule': {'briefSummary': 'A prospective randomised control trial of the impact of the fundus edometrial incision during hysteroscopy in oocyte recipients.', 'detailedDescription': 'A prospective randomised control trial of the impact of the fundus edometrial incision during hysteroscopy in women without intrauterine pathology which is likely to have an adverse effect on reproductive outcomes. The study populations will be constituted by oocyte recipients.\n\nStudy group: Hysteroscopy with fundus endometrial incision Control group: Office Hysteroscopy without any endometrial injury'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women 30-50 years old with infertility undergoing IVF treatment with donor oocytes. 1-2 blastocysts are transferred per cycle with endometrium preparation with Hormone Replacement Therapy.The study population has underwent hysteroscopy with fundus endometrial incision before the embryo transfer.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* oocyte acceptors\n* age 30-50\n* embryo transfer with Hormone Replacement Therapy\n* embryo transfer within 6 months of hysteroscopy\n\nExclusion Criteria:\n\n* previous uterine pathology\n* sperm sample \\<1mil/ml\n* leiomyoma\n* septate uterus'}, 'identificationModule': {'nctId': 'NCT04580056', 'briefTitle': 'Hysteroscopy With Fundus Uterus Scratching Incision VS Office Hysteroscopy Before ET With Donor Eggs', 'organization': {'class': 'OTHER', 'fullName': 'Assisting Nature'}, 'officialTitle': 'Oocyte Recipients Before Embryo Transfer Randomization: Hysteroscopy With Fundus Uterus Scratching VS Hysteroscopy Without Fundus Uterus Scratching', 'orgStudyIdInfo': {'id': 'Uterus Incision- Don'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Incision Group', 'description': 'Women following IVF treatment with donor oocytes who underwent during hysteroscopy fundus endometrial scratching by incision, before embryo transfer.', 'interventionNames': ['Procedure: Uterine fundus endometrial incision during hysteroscopy']}, {'label': 'No incision Group', 'description': 'Women following IVF treatment with donor oocytes who underwent office hysteroscopy without fundus endometrial scratching by incision, before embryo transfer.'}], 'interventions': [{'name': 'Uterine fundus endometrial incision during hysteroscopy', 'type': 'PROCEDURE', 'description': 'Uterine fundus endometrial scratching during hysteroscopy by incision', 'armGroupLabels': ['Incision Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57001', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Assisting Nature', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'overallOfficials': [{'name': 'Evangelos Papanikolaou, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assisting Nature, 3rd Department of Obstetrics and Gynaecology, Aristotle University of Thessaloniki'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assisting Nature', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aristotle University Of Thessaloniki', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof Dr Papanikolaou G. Evangelos', 'investigatorFullName': 'Papanikolaou Evaggelos', 'investigatorAffiliation': 'Assisting Nature'}}}}