Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-02-21 @ 11:36 PM
Study NCT ID:
NCT04265495
Status:
UNKNOWN
Last Update Posted:
2021-09-28
First Post:
2020-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dual Trigger, Urinary HCG or Recombinant HCG, Which is the Best !?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-27', 'studyFirstSubmitDate': '2020-02-09', 'studyFirstSubmitQcDate': '2020-02-09', 'lastUpdatePostDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical pregnancy rate,', 'timeFrame': '4 WEEKS'}, {'measure': 'implantation rate,', 'timeFrame': '2 WEEKS'}, {'measure': 'incidence of OHSS.', 'timeFrame': '1 WEEK'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dual trigger implantation,', 'HCG', 'OHSS', 'ANTAGONIST'], 'conditions': ['IVF']}, 'descriptionModule': {'briefSummary': 'a comparative study among dual trigger, urinary HCG and recombinant HCG regarding the outcome of ICSI- antagonist cycles', 'detailedDescription': 'a comparative study among dual trigger, urinary HCG and recombinant HCG regarding the outcome (oocyte quality, fertilization rate, implantation rate, clinical pregnancy rate as well as the incidence of OHSS) in ICSI- antagonist cycles'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '22 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients \\<40 years of age who underwent IVF/ICSI cycles using a GnRH antagonist protocol, then at the time of triggering, we divided the patients to 3 groups by for triggering by a dual trigger, urinary HCG and recombinant HCG and then will check the outcome regarding the maturity and oocyte quality, implantation rate, clinical pregnancy rate as well as incidence of OHSS', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients \\<40 years of age who underwent IVF/ICSI cycles using a GnRH antagonist protocol\n\nExclusion Criteria:\n\n* age: \\> 40 years\n* BMI \\> 30 ,\n* long agonist protocol\n* were chromosomal and genetic disorders, abnormal ultrasonogram of the uterine cavity'}, 'identificationModule': {'nctId': 'NCT04265495', 'briefTitle': 'Dual Trigger, Urinary HCG or Recombinant HCG, Which is the Best !?', 'organization': {'class': 'OTHER', 'fullName': 'Al Baraka Fertility Hospital'}, 'officialTitle': 'Dual Trigger, Urinary HCG or Recombinant HCG, Which is the Best !? a Prospective Randomized Controlled Comparative Study', 'orgStudyIdInfo': {'id': 'AlBarakaBH-KAMAL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'DUAL TRIGGERING', 'description': 'PATIENTS WILL RECEIVE DUAL TRIGGERING'}, {'label': 'URINARY HCG', 'description': 'PATIENTS WILL RECEIVE URINARY HCG'}, {'label': 'RECOMBINANT HCG', 'description': 'PATIENTS WILL RECEIVE RECOMBINANT HCG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '15006', 'city': 'Manama', 'state': 'Adliya', 'status': 'RECRUITING', 'country': 'Bahrain', 'contacts': [{'name': 'AHMED BARAKAT, FRCOG', 'role': 'CONTACT', 'email': 'ahmed_barakat@yahoo.com', 'phone': '0097336660500'}, {'name': 'Kamal Rageh, M.D', 'role': 'CONTACT', 'email': 'dr_kamal_rageh@yahoo.com', 'phone': '0097333153871'}], 'facility': 'Al-BARAKA FERTILITY HOSPITAL', 'geoPoint': {'lat': 26.22787, 'lon': 50.58565}}], 'centralContacts': [{'name': 'Kamal eldin Rageh, M.D.', 'role': 'CONTACT', 'email': 'dr_kamal_rageh@yahoo.com', 'phone': '0097333153871'}, {'name': 'Ahmed Barakat, FRCOG', 'role': 'CONTACT', 'email': 'ahmed.barakat@yahoo.com', 'phone': '0097317727888'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al Baraka Fertility Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DOCTOR', 'investigatorFullName': 'Dr. Kamal Rageh', 'investigatorAffiliation': 'Al Baraka Fertility Hospital'}}}}