Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-27 @ 11:09 PM
Study NCT ID:
NCT02245750
Status:
UNKNOWN
Last Update Posted:
2014-09-22
First Post:
2014-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Value of Routine Hysteroscopy Prior to IVF/ICSI Cycles
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015907', 'term': 'Hysteroscopy'}], 'ancestors': [{'id': 'D003944', 'term': 'Diagnostic Techniques, Obstetrical and Gynecological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-09-19', 'studyFirstSubmitDate': '2014-04-24', 'studyFirstSubmitQcDate': '2014-09-19', 'lastUpdatePostDateStruct': {'date': '2014-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': '• Uterine anomalies detected by Hysteroscopy', 'timeFrame': '6 months'}], 'primaryOutcomes': [{'measure': '• Clinical pregnancy rate.', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': '• Live Birth Rate', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hysteroscopy - recurrent implantation failure'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'In the current study the investigators hypothesize that Routine Hysteroscopy prior to IVF/ICSI cycle increases the clinical pregnancy rate.', 'detailedDescription': 'A randomized controlled study involving 300 patients with recurrent implantation failure'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient's age ranged from 20-40 years.\n2. Normal appearance of the uterine cavity on hysterosalpingography.\n3. Patients prepared for IVF/ICSI cycle.\n\nExclusion Criteria:\n\n1. Patients who have any contraindications for hysteroscopy. (Menstruation, pregnancy, severe vaginitis or cervicitis, endometrial infection and history of Pelvic Inflammatory Diseases).\n2. Patients with uterine cavity pathology previously known to the examiner.\n3. Patients with previous uterine surgery such as myomectomy.\n4. Patients with abnormal HSG."}, 'identificationModule': {'nctId': 'NCT02245750', 'briefTitle': 'Value of Routine Hysteroscopy Prior to IVF/ICSI Cycles', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams Maternity Hospital'}, 'orgStudyIdInfo': {'id': 'Routine Hysterscopy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Routine Invistigations', 'description': 'ICSI with long luteal phase protocol'}, {'type': 'EXPERIMENTAL', 'label': 'Hysteroscopy', 'description': 'hysteroscopy will be done prior to the ICSI cycle', 'interventionNames': ['Device: Hysteroscopy']}], 'interventions': [{'name': 'Hysteroscopy', 'type': 'DEVICE', 'description': 'hysteroscopy and endometrial injury prior to the IVF/ICSI cycle', 'armGroupLabels': ['Hysteroscopy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'mostafa F gomaa, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ain Shams Maternity hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ahmed M Mohammed, MbbcH', 'role': 'CONTACT', 'email': 'ahmadmarzok85@gmail.com', 'phone': '00201110362860'}, {'name': 'mostafa f gomaa, MD', 'role': 'CONTACT', 'email': 'mostafafouadg@gmail.com', 'phone': '01226188993'}], 'overallOfficials': [{'name': 'mostafa f gomaa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams Maternity Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Value of Routine Hysteroscopy prior to IVF/ICSI Cycles: A Randomized Control Trial', 'investigatorFullName': 'mostafa fouad', 'investigatorAffiliation': 'Ain Shams Maternity Hospital'}}}}