Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-26 @ 1:34 AM
Study NCT ID:
NCT00837733
Status:
COMPLETED
Last Update Posted:
2009-02-05
First Post:
2009-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endometrial Local Injury and Implantation Failure
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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-04', 'studyFirstSubmitDate': '2009-02-04', 'studyFirstSubmitQcDate': '2009-02-04', 'lastUpdatePostDateStruct': {'date': '2009-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implantation Rate,Chemical pregnancy rate, Clinical pregnancy rate', 'timeFrame': 'One year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Endometrial biopsy', 'IVF/ICSI', 'Pregnancy outcome', 'Recurrent implantation failure'], 'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '34110001', 'type': 'DERIVED', 'citation': 'Lensen SF, Armstrong S, Gibreel A, Nastri CO, Raine-Fenning N, Martins WP. Endometrial injury in women undergoing in vitro fertilisation (IVF). Cochrane Database Syst Rev. 2021 Jun 10;6(6):CD009517. doi: 10.1002/14651858.CD009517.pub4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the influence of endometrial biopsy on increasing implantation rate in patients with recurrent implantation failures, 93 women with at least two implantation failures were evaluated. In case group endometrial biopsy was obtained from 48 patients in the luteal phase of previous cycle and implantation and clinical pregnancy rate were compared with 45 patients in control group. The results suggest that in vitro fertilization or intracytoplasmic sperm injection after endometrial biopsy increase pregnancy outcome.', 'detailedDescription': 'In a randomized control trial study, 93 women with at least two implantation failures were evaluated. In case group endometrial biopsy was obtained from 48 patients in the luteal phase of previous cycle and implantation and clinical pregnancy rate were compared with 45 patients in control group.\n\nThe implantation rate was determined as 10.9% in biopsy group compared with 3.38% in controls. Clinical pregnancy rate was significantly higher in case group than controls (27.1% and 8.9% respectively'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '39 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women with recurrent implantation failure which was defined as 2-6 cycles unsuccessful of IVF-ET in which more than 10 high grade embryo were transferred\n\nExclusion Criteria:\n\n* age over than 40 years old\n* poor responders to ovarian stimulation'}, 'identificationModule': {'nctId': 'NCT00837733', 'briefTitle': 'Endometrial Local Injury and Implantation Failure', 'organization': {'class': 'OTHER', 'fullName': 'Yazd Research & Clinical Center for Infertility'}, 'officialTitle': 'Endometrial Local Injury Improves the Pregnancy Rate Among Recurrent Implantation Failure Patients Undergoing IVF/ICSI', 'orgStudyIdInfo': {'id': '1551354'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biopsy catheter', 'description': 'Biopsy catheter (Pipelle de Cornier, Prodimed, Neuilly-en-Thelle, France', 'interventionNames': ['Procedure: Endometrial biopsy']}], 'interventions': [{'name': 'Endometrial biopsy', 'type': 'PROCEDURE', 'otherNames': ['biopsy catheter (Pipelle de Cornier, Prodimed, France'], 'description': 'Endometrial biopsy was done at luteal phase on the day 21-26 of spontaneous menstrual cycles, when GnRH agonist uses begun. Endometrial samples were taken by a biopsy catheter', 'armGroupLabels': ['Biopsy catheter']}, {'name': 'Endometrial Biopsy', 'type': 'PROCEDURE', 'otherNames': ['Pipelle de Cornier, Prodimed, Neuilly-en-Thelle, France'], 'description': 'Biopsy catheter', 'armGroupLabels': ['Biopsy catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8916877391', 'city': 'Yazd', 'state': 'Yazd Province', 'country': 'Iran', 'facility': 'Research and Clinical Center for Infertility', 'geoPoint': {'lat': 31.89722, 'lon': 54.3675}}], 'overallOfficials': [{'name': 'Mohammad Ali Karimzadeh, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research and Clinical Center for Infertility'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yazd Research & Clinical Center for Infertility', 'class': 'OTHER'}, 'collaborators': [{'name': 'Yazd Medical University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Department of Obstetrics and Gynecology', 'oldOrganization': 'Yazd Research & Clinical Center for Infertility'}}}}