Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-01-05 @ 9:47 AM
Study NCT ID:
NCT02752568
Status:
UNKNOWN
Last Update Posted:
2016-04-27
First Post:
2016-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assisted Hatching Versus Endometrial Scratch in Recurrent Implantation Failure
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': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-26', 'studyFirstSubmitDate': '2016-04-25', 'studyFirstSubmitQcDate': '2016-04-26', 'lastUpdatePostDateStruct': {'date': '2016-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of patients with positive pregnancy test', 'timeFrame': '2 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Recurrent Implantation Failure']}, 'referencesModule': {'references': [{'pmid': '33730422', 'type': 'DERIVED', 'citation': 'Lacey L, Hassan S, Franik S, Seif MW, Akhtar MA. Assisted hatching on assisted conception (in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI)). Cochrane Database Syst Rev. 2021 Mar 17;3(3):CD001894. doi: 10.1002/14651858.CD001894.pub6.'}]}, 'descriptionModule': {'briefSummary': '300 recurrent implantation failure patients will be alternatively assigned to assisted hatching , endometrial scratch , and no treatment ,100 patients in each group', 'detailedDescription': 'Group 1 consists of 100 patients will undergo endometrial scratch followed by controlled ovarian hyperstimulation Group 2 consists of 100 patients will undergo controlled ovarian hyperstimulation\\& assisted hatching Group 3 consists of 100 patients will undergo controlled ovarian hyperstimulation'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* recurrent implantation failure\n* normal uterine cavity by transvaginal ultrasound\n\nExclusion Criteria:\n\n* endometrial polyp or fibroid distorting the endometrium\n* hydrosalpinx\n* preimplantation genetic diagnosis\n* severe male factor'}, 'identificationModule': {'nctId': 'NCT02752568', 'briefTitle': 'Assisted Hatching Versus Endometrial Scratch in Recurrent Implantation Failure', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'Assisted Hatching Versus Endometrial Scratch in Recurrent Implantation Failure.A Comparative Study', 'orgStudyIdInfo': {'id': 'ivfobgyn'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Endometrial scratch group', 'description': 'endometrial scratch controlled ovarian hyperstimulation', 'interventionNames': ['Procedure: endometrial scratch', 'Procedure: controlled ovarian hyperstimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Assisted hatching group', 'description': 'assisted hatching controlled ovarian hyperstimulation', 'interventionNames': ['Procedure: assisted hatching', 'Procedure: controlled ovarian hyperstimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'ovarian stimulation only group', 'description': 'controlled ovarian hyperstimulation', 'interventionNames': ['Procedure: controlled ovarian hyperstimulation']}], 'interventions': [{'name': 'endometrial scratch', 'type': 'PROCEDURE', 'otherNames': ['endometrial injury'], 'description': 'midluteal endometrial scratch using Novak curette under general anesthesia in the cycle preceding stimulation', 'armGroupLabels': ['Endometrial scratch group']}, {'name': 'assisted hatching', 'type': 'PROCEDURE', 'otherNames': ['laser hatching'], 'description': 'using Octax laser 20120644-laser 5452', 'armGroupLabels': ['Assisted hatching group']}, {'name': 'controlled ovarian hyperstimulation', 'type': 'PROCEDURE', 'description': 'using merional\\&/ or fostimon doses individualized as judged by patient age \\& ovarian reserve \\& monitored by follicular size \\& serum estradiol', 'armGroupLabels': ['Assisted hatching group', 'Endometrial scratch group', 'ovarian stimulation only group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'suzy abdelaziz, lecturer', 'role': 'CONTACT', 'email': 'suzyabdelaziz92@gmail.com', 'phone': '01003726195'}], 'overallOfficials': [{'name': 'suzy abdelaziz, lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'kasrelaini hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of obstetrics & gynecology', 'investigatorFullName': 'suzy abdelaziz Abdelhamid', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}