Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2026-02-23 @ 3:02 PM
Study NCT ID:
NCT02999958
Status:
COMPLETED
Last Update Posted:
2018-12-03
First Post:
2016-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adding Antioxidants Into Human Sequential Culture Media System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-01-29', 'releaseDate': '2021-01-08'}, {'resetDate': '2021-03-19', 'releaseDate': '2021-02-24'}], 'estimatedResultsFirstSubmitDate': '2021-01-08'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D000975', 'term': 'Antioxidants'}, {'id': 'D000108', 'term': 'Acetylcarnitine'}, {'id': 'D000111', 'term': 'Acetylcysteine'}, {'id': 'D008063', 'term': 'Thioctic Acid'}], 'ancestors': [{'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020011', 'term': 'Protective Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D002331', 'term': 'Carnitine'}, {'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-30', 'studyFirstSubmitDate': '2016-12-16', 'studyFirstSubmitQcDate': '2016-12-16', 'lastUpdatePostDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of good quality blastocyst (GQB) per fertilized oocyte on day 5', 'timeFrame': '7 months'}], 'secondaryOutcomes': [{'measure': 'Embryo development on day 3, 5 & 6', 'timeFrame': '7 months'}, {'measure': 'Embryo quality on day 3, 5 & 6', 'timeFrame': '7 months'}, {'measure': 'Total blastocyst rate', 'timeFrame': '7 months'}, {'measure': 'Blastocyst utilization rate per fertilized oocyte', 'timeFrame': '7 months'}, {'measure': 'Biochemical pregnancy rate', 'timeFrame': '8 months'}, {'measure': 'Clinical pregnancy rate', 'timeFrame': '9 months'}, {'measure': 'Implantation rate', 'timeFrame': '8 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Culture Media', 'Blastocyst', 'Antioxidants', 'Embryo', 'Human', 'Oxygen']}, 'referencesModule': {'references': [{'pmid': '10856474', 'type': 'RESULT', 'citation': 'Gardner DK, Lane M, Stevens J, Schlenker T, Schoolcraft WB. Blastocyst score affects implantation and pregnancy outcome: towards a single blastocyst transfer. Fertil Steril. 2000 Jun;73(6):1155-8. doi: 10.1016/s0015-0282(00)00518-5.'}]}, 'descriptionModule': {'briefSummary': 'Upon collection, human oocytes are fertilized and culture up to the blastocyst stage, followed by transfer and / or cryopreservation. Culture media systems have been developed that support each step of this process. Although these culture media systems try to mimic the natural environment, several components of the in-vivo situation are not present in today´s media. One such component is anti-oxidants that may protect embryos against damage by reactive oxygen species.\n\nThis investigation aims to compare blastocyst development using 2 different types of culture media systems, one of which contains antioxidants. Patients having at least eight oocytes and meeting other inclusion criteria can be included in this investigation.\n\nIt is a prospective randomized multicenter study randomly dividing oocytes into two groups and assessing parameters of embryo development from fertilization up to blastocyst formation until day six. Embryos with acceptable developmental characteristics can be transferred into the uterus or cryopreserved for later use.\n\nThe investigation is designed as a superiority study comparing utilization rate of blastocysts per normally fertilized oocyte using both media systems. In patients receiving embryo transfer in the fresh treatment cycle, detection of clinical pregnancy by ultrasound after 12 weeks gestation is the final endpoint of the investigation.', 'detailedDescription': 'Study objective:\n\nStudy comparing blastocyst development on the same cohort of oocytes using two different media systems, sequential G-Series media versus sequential G-Series media supplemented with antioxidants.\n\nPrimary endpoint:\n\nPercentage of good quality blastocysts (GQB) per fertilized oocyte on day 5.\n\nSecondary endpoints:\n\nEmbryo development day 3, 5 and 6 Embryo quality day 3, 5 and 6 Total blastocyst formation (day 5 and day 6) Utilization rate (embryos available for transfer and cryopreservation) Biochemical pregnancy rate Implantation rate Clinical pregnancy rate\n\nSetup:\n\nProspective oocyte sibling, superiority study\n\nMATERIALS AND METHODS\n\nIntervention:\n\nNew type of embryo culture media used for in vitro culture of human IVF embryos.\n\nPower analysis:\n\nThe planning and the power analysis was made together with a statistician, Nils-Gunnar Pehrsson.\n\nFrom retrospective data using simulation, the intra individual SD for the difference in % GQB between the two media strategies was estimated to 32%. In order to find a difference in 8% in GQB between the two media with power 80% with paired T-test 128 couples will be needed.\n\nRandomization:\n\nCouples will be enrolled in the study at oocyte pick up (day 0). A minimum of 8 cumulus-oocyte-complexes is required for participation.\n\nStratified randomization of the oocytes by couple will be performed. For each couple the oocytes will be numbered.\n\nThese oocytes for each couple will then be block (by two) randomized to the two media types; A (Traditional G-Series media system = Control) and B (G-Series media system with antioxidant = intervention). In both groups traditional culture will be performed. Allocation will be performed in a 1:1 ratio according to a unique randomization list for each couple.\n\nBlinding:\n\nTo minimize possible bias for the primary outcome (GQB D5) the embryologist performing the morphological evaluation on day 5/6 will not know which group the embryos belong to.\n\nBoth the physician and the couple will be blinded in respect to from which group an embryo was selected for transfer.\n\nIVF treatment procedure:\n\nA traditional IVF treatment will be performed including ovarian stimulation and oocyte pick-up using the standard methods at the clinics.\n\nEmbryo assessment on day 3 according to Alpha/ESHRE consensus criteria and on day 5 according to Gardner score.\n\nMorphological scoring Embryo development and morphology on day 3 will be scored based on the Alpha/ESHRE Consensus criteria. Blastocyst development and morphology will be scored according to a published scoring system for blastocysts and will be documented with individual photos of each blastocyst. Embryo \\& Blastocyst scoring will be performed under an inverted microscope on day 3 and days 5 \\& 6, respectively. Blastocysts that have a score equal or higher than 3BB are considered as GQB.\n\nDOCUMENTATION All patients participating in the study will be documented on a computerized CRF. This document will contain study-specific relevant clinical and laboratory data from the specific IVF cycle.\n\nSTATISTICAL ANALYSIS Both an Intention-to-Treat (ITT) population and a Per Protocol (PP) population will be defined. Primary efficacy variable in this superiority study will be difference in % GQB between the two media types for each couple. Primary statistical analysis will be two-sided paired T-test regarding the mean of difference in % GQB between Standard sequential culture media and Antioxidant media on the ITT population. A two sided 95% confidence interval for the mean difference in % GOB between the two media will be calculated. All significance tests will be two-sided and conducted at the 5% significance level.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Minimum eight cumulus-oocyte-complexes.\n* Couples with female, male or unexplained infertility intending to undergo IVF\n* The couple should have received verbal and written information/consent about the study.\n* Blastocyst culture and embryo transfer is decided.\n* If the couple fulfills the criteria above their consent to participate must be given and documented in the couple's medical journal.\n\nExclusion Criteria:\n\n* Previous participation in the study\n* PGD/PGS\n* Surgically retrieved sperm cells (TESA / TESE)\n* If split IVF is needed\n* Less than eight cumulus-oocyte-complexes\n* More than thirty cumulus-oocyte-complexes"}, 'identificationModule': {'nctId': 'NCT02999958', 'acronym': 'Antioxidants', 'briefTitle': 'Adding Antioxidants Into Human Sequential Culture Media System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vitrolife'}, 'officialTitle': 'Comparison of G-Series Media System With Antioxidants Versus Standard G-Series Media System', 'orgStudyIdInfo': {'id': 'AOX-G_Series-2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Sequential culture media without addition of antioxidants'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment', 'description': 'Sequential culture media with the addition of antioxidants', 'interventionNames': ['Biological: Antioxidants']}], 'interventions': [{'name': 'Antioxidants', 'type': 'BIOLOGICAL', 'otherNames': ['Acetyl-L-carnitine (ALC)', 'N-acetyl-L-cysteine (NAC)', 'alpha-Lipoic acid (ALA)'], 'description': 'In the Treatment Arm, the G-Series culture media system will be used with antioxidants', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8120013', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Kuramoto Women´s Clinic', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '135-0042', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Kiba Park Clinic', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'A Yoshida, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kiba Park Clinic, Tokyo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vitrolife', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-01-08', 'type': 'RELEASE'}, {'date': '2021-01-29', 'type': 'RESET'}, {'date': '2021-02-24', 'type': 'RELEASE'}, {'date': '2021-03-19', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Vitrolife'}}}}