Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-26 @ 1:22 PM
Study NCT ID:
NCT05722067
Status:
RECRUITING
Last Update Posted:
2025-02-20
First Post:
2022-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improvement of Fertilization Rate and Embryo Quality by Treating Calcium Ionophore in IVF Patients: a Sibling Oocyte Control Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}, {'id': 'C565840', 'term': 'Long Qt Syndrome 3'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061207', 'term': 'Calcium Ionophores'}], 'ancestors': [{'id': 'D007476', 'term': 'Ionophores'}, {'id': 'D049990', 'term': 'Membrane Transport Modulators'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-19', 'studyFirstSubmitDate': '2022-11-20', 'studyFirstSubmitQcDate': '2023-02-08', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fertilization rate', 'timeFrame': 'Day 1', 'description': 'The normal fertilization rate will defined as the number of zygotes with 2PN and 2PB per the total number of mature oocytes'}], 'secondaryOutcomes': [{'measure': 'blastocyst formation rate', 'timeFrame': 'Day 5', 'description': 'NO. of blastocysts per 2PN zygotes'}, {'measure': 'top-quality blastocyst formation rate', 'timeFrame': 'Day 5', 'description': 'No. of 3AA, 4AA, 5AA or 6AA blastocysts / 2PN zygotes'}, {'measure': 'pregnancy outcome', 'timeFrame': '1 year', 'description': 'pregnancy rates, abortion rate, live birth rates,congenital anomaly rate'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['artificial oocyte activation', 'calcium ionophore', 'ivf', 'poor responder'], 'conditions': ['IVF', 'Infertility', 'Artificial Oocyte Activation']}, 'descriptionModule': {'briefSummary': 'GM508 CultActive is a bicarbonate buffered reagent and ready-to-use designed to investigate oocytes of patients with failed fertilization after previous Intracytoplasmatic Sperm Injection cycles. The investigators hypothesize that GM508 CultActive will improve the fertilization rate and embryo development of such IVF patients (a history of poor fertilization, a history of poor embryo quality, and over 40 years old expected challenging to conceive).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Low fertilization rate in previous IVF cycle (\\<30%), or\n* Poor embryo developmental problems in previous IVF cycle, or\n* Diminished ovarian reserve (AMH\\<1.2 or AFC\\<5) and/or more than 40 y/o.\n\nExclusion Criteria:\n\n* Without or just one oocyte picked up'}, 'identificationModule': {'nctId': 'NCT05722067', 'acronym': 'GM508 in IVF', 'briefTitle': 'Improvement of Fertilization Rate and Embryo Quality by Treating Calcium Ionophore in IVF Patients: a Sibling Oocyte Control Study', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Improved the Low Fertilization Rates and Increased the High-quality Embryogenesis by Treatment with Calcium Ionophore GM508 CultActive Optimized Medium in Vitro Fertilization (IVF) Patients', 'orgStudyIdInfo': {'id': '202200969A3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'oocytes treated with calcium ionophore', 'description': 'Oocytes treated with a ready-to-use ionophore compound (GM508 CultActive, Gynemed) within 15 min after ICSI (or 18 min in IVF). After 15 min of incubation in GM508 CultActive and a thorough washing process, the oocytes subjected to AOA will transfer to the same time-lapse culture dish with the controlled sibling group.', 'interventionNames': ['Other: calcium ionophore']}, {'type': 'NO_INTERVENTION', 'label': 'oocytes undergo routine IVF/ICSI protocol', 'description': 'Untreated control oocytes will immediately place into the time-lapse imaging system, and the culture protocol was routine.'}], 'interventions': [{'name': 'calcium ionophore', 'type': 'OTHER', 'otherNames': ['GM508 CultActive'], 'description': 'The intervention group will be treated with a ready-to-use ionophore medium (GM508 CultActive, Gynemed) within 15 min after ICSI (or 18 min in IVF) based on the situation of sperm. After 15 min of incubation in GM508 CultActive and a thorough washing process, the oocytes will be cultured in the same protocol as the control group.', 'armGroupLabels': ['oocytes treated with calcium ionophore']}]}, 'contactsLocationsModule': {'locations': [{'zip': '123', 'city': 'Kaohsiung City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Kuo-Chung Lan, PhD', 'role': 'CONTACT', 'email': 'lankuochung@gmail.com', 'phone': '+886-975056415'}, {'name': 'Ni-Chin Tsai, MD', 'role': 'CONTACT', 'email': 'ninytsai@gmail.com', 'phone': '+886-975369271'}], 'facility': 'Chang Gung Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}