Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-22 @ 7:02 AM
Study NCT ID:
NCT02660294
Status:
UNKNOWN
Last Update Posted:
2016-03-22
First Post:
2016-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intrauterine Autologous PRP Infusion Compared to HRT for Enhancing Endometrial Thickness in Patients Undergoing ICSI
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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-19', 'studyFirstSubmitDate': '2016-01-16', 'studyFirstSubmitQcDate': '2016-01-16', 'lastUpdatePostDateStruct': {'date': '2016-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'endometrial thickness in mm', 'timeFrame': '72 hours', 'description': 'using transvaginal ultrasound to measure endometrial thickness in mm'}], 'secondaryOutcomes': [{'measure': 'clinical pregnancy rate', 'timeFrame': '4 weeks after embryo transfer', 'description': 'using transvaginal ultrasound to detect fetal cardiac activity'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'Successful embryo implantation needs an optimum embryonic development with a receptive endometrium. Endometrial thickness is an independant factor for endometrial receiptivity. The aim of that trial is to assess the benefecial effect of platelt rich plasma in copmarison with standard hormonal therapy.', 'detailedDescription': 'This is a single blinded randomized trial comparing the effect of of platlet rich plasma versus hormonal therapy on endometrial thickness and consequently endometrial receptivity. The primary endpoint of this trial is clinical pregnancy rate.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing ICSI\n* endometrial thickness less than 7 mm on early follicular phase\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02660294', 'briefTitle': 'Intrauterine Autologous PRP Infusion Compared to HRT for Enhancing Endometrial Thickness in Patients Undergoing ICSI', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Intrauterine Autologous Platelet -Enriched Plasma Infusion Compared to Hormonal Replacement Therapy for Enhancing Endometrial Thickness in Patients Undergoing ICSI', 'orgStudyIdInfo': {'id': 'PRP-IVF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Platlet rich plasma', 'description': 'For those with endometrial thickness less than 7 mm intrauterine injection of platlet rich plasma (PRP) for enhancing endometrial thickness and receptivity', 'interventionNames': ['Biological: platlet rich plasma']}, {'type': 'NO_INTERVENTION', 'label': 'Hormone replacement therapy', 'description': 'Oral intake of estradiol valerate for those with endometrial thickness less than 7 mm will improve endometrial receptivity'}], 'interventions': [{'name': 'platlet rich plasma', 'type': 'BIOLOGICAL', 'description': 'Platelet-rich plasma (PRP) is prepared from fresh whole blood which is collected from a peripheral vein, stored in acid citrate dextrose solution A (ACD-A) anticoagulant and processed to increase platelets by separating various components of blood', 'armGroupLabels': ['Platlet rich plasma']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Cairo Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Rasha M Abdul-hady, MD', 'role': 'CONTACT', 'email': 'rashamedhat30@gmail.com', 'phone': '1224448449', 'phoneExt': '0020'}, {'name': 'ahmed M kotb, MD', 'role': 'CONTACT', 'email': 'ahmedmkotp@hotmail.com', 'phone': '1004711414', 'phoneExt': '0020'}], 'facility': 'Rasha', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'rasha Dr medhat, MD', 'role': 'CONTACT', 'email': 'RASHAMEDHAT30@GMAIL.COM', 'phone': '1224448449', 'phoneExt': '0020'}, {'name': 'ahmed DR kotb, MD', 'role': 'CONTACT', 'email': 'ahmedmkotp@hotmail.com', 'phone': '1008681999', 'phoneExt': '0020'}], 'overallOfficials': [{'name': 'RASHA DR MEDHAT, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DR. Rasha Medhat Abdul-hady', 'investigatorFullName': 'rasha medhat abdul-hady', 'investigatorAffiliation': 'Ain Shams University'}}}}