Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-02-12 @ 10:46 PM
Study NCT ID:
NCT01955356
Status:
COMPLETED
Last Update Posted:
2023-01-11
First Post:
2013-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Embryo Implantation After Induced Endometrial Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-09', 'studyFirstSubmitDate': '2013-09-28', 'studyFirstSubmitQcDate': '2013-09-28', 'lastUpdatePostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ongoing implantation rate (OIR)', 'timeFrame': '12 weeks of pregnancy'}], 'secondaryOutcomes': [{'measure': 'Live born rate (LBR)', 'timeFrame': '9 months after embryo transfer'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Scratching', 'Endometrial biopsy', 'Ongoing embryo implantation', 'Assisted reproductive techniques'], 'conditions': ['Sterility']}, 'descriptionModule': {'briefSummary': 'Some studies have revealed that an induced endometrial injury could improve embryo human implantation in patients with implantation failure.\n\nThe purpose of this study is to determine whether the induced endometrial injury could be beneficial for regular patients undergoing IVF', 'detailedDescription': 'Endometrial induced injury has been suggested that could improve embryo implantation in cases of patients with recurrent implantation failure. The mechanisms that induce that improvement remain unknown.\n\nWe want to analyse if the endometrial induce injury could be useful in cases of standard patients who require assisted reproductive techniques.\n\nFor that purpose we will start a randomized controlled trial with the ideal background in implantation in ART, the egg donation programme.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 19-44 aged women\n* 19-29.9 Kg/m2.\n* 1st or 2nd fresh embryo transfer ( egg donation).\n* 1 or 2 blastocysts available.\n* written agreement.\n* \\> or = 6 mms endometrial thickness.\n\nExclusion Criteria:\n\n* Premature ovarian failure.\n* Endometrial pathology.\n* Insufficient endometrial development.\n* Hydrosalpinx\n* Mullerian malformations.'}, 'identificationModule': {'nctId': 'NCT01955356', 'briefTitle': 'Embryo Implantation After Induced Endometrial Injury', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Valenciano de Infertilidad, IVI VALENCIA'}, 'officialTitle': 'Evaluation of Induced Endometrial Injury in the Subsequent IVF Cycle.', 'orgStudyIdInfo': {'id': '1306-C-119-CV/IVI Valencia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Scratching', 'description': 'induced endometrial injury', 'interventionNames': ['Procedure: Scratching']}, {'type': 'NO_INTERVENTION', 'label': 'No scratching', 'description': 'None intervention'}], 'interventions': [{'name': 'Scratching', 'type': 'PROCEDURE', 'otherNames': ['Endometrial induced injury'], 'description': 'Endometrial biopsy', 'armGroupLabels': ['Scratching']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46015', 'city': 'Valencia', 'country': 'Spain', 'facility': 'IVI Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Carmina Vidal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IV VALENCIA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Valenciano de Infertilidad, IVI VALENCIA', 'class': 'OTHER'}, 'collaborators': [{'name': 'IVI Madrid', 'class': 'OTHER'}, {'name': 'IVI Barcelona', 'class': 'OTHER'}, {'name': 'IVI Murcia', 'class': 'OTHER'}, {'name': 'Vida Recoletas Sevilla', 'class': 'OTHER'}, {'name': 'IVI Bilbao', 'class': 'OTHER'}, {'name': 'IVI Vigo', 'class': 'OTHER'}, {'name': 'Instituto Valenciano de Infertilidad, IVI Alicante', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Obstetrics and Gynecology', 'investigatorFullName': 'Carmina Vidal, MD', 'investigatorAffiliation': 'Instituto Valenciano de Infertilidad, IVI VALENCIA'}}}}