Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:08 AM
Study NCT ID:
NCT04976920
Status:
UNKNOWN
Last Update Posted:
2023-11-14
First Post:
2021-07-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Metabolomics Non Selection Study - Vitrolife Media
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 205}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-13', 'studyFirstSubmitDate': '2021-07-15', 'studyFirstSubmitQcDate': '2021-07-15', 'lastUpdatePostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Negative predictive value (NPV) and positive predictive value (PPV) for MEI vs. expected implantation based solely on morphology.', 'timeFrame': 'Approximately 4-5 months, inclusive of IVF cycle, embryo transfer and monitoring up to eight weeks', 'description': 'PPV (MEI high potential implanting / Total implanting), NPV (MEI low potential implanting / Total not implanting)'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['IVF', 'genetic screening', 'preimplantation genetic testing'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'In this study, study investigators will collect embryo culture media on day 5 of vitro fertilization (IVF) culture, prior to vitrification and embryo transfer for testing via Metabolomic screening. Metabolomics is a new, non-invasive method of embryo selection which involves testing discarded embryo culture media for analytes secreted by the developing embryo. These analytes can be used to determine the implantation potential, and ploidy, of the embryo.', 'detailedDescription': 'Patients will undergo a routine IVF cycle. This will include ovarian stimulation, egg retrieval and fertilization of oocytes through intracytoplasmic sperm injection (ICSI). All fertilized oocytes will be cultured up to blastocyst for five to six days.\n\nSpent media will be collected on day 5-6 for all embryos reaching blastocyst on day 5, and on day 6 for those reaching blastocyst on day 6. The spent culture media will be sent to a lab for metabolomic analysis.\n\nFor the embryo transfer, the best morphology blastocyst will be selected for transfer by the New Hope embryologist.\n\nApproximately 8-11 days after the embryo transfer, the patient will return to the clinic for a serum pregnancy test. Should the test be negative, they will be closed out of the study. Should the test be positive, they will continue to be monitored.\n\nThe patient will return to the clinic at approximately 8 weeks after embryo transfer for a serum pregnancy test, and an ultrasound to detect fetal heartbeat. The outcome will be documented and the patient closed out of the study at this time.\n\nThe embryo transfer outcome will be compared to the metabolomics result to determine the NPV and PPV of metabolomics vs implantation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '38 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients recruited from an IVF center', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women of any age, 25% of patients \\<35 years, 25% of patients 35-37, 25% of patients 38-40, and 25% of patients \\>40 years.\n* Signed Subject Consent Form. No inferior limit on number of eggs\n\nExclusion Criteria:\n\nAt the time of initial visit:\n\n* Require or request PGT of any kind\n* Low ovarian reserve defined as follicle stimulating hormone (FSH) \\>10 IU/L on day 2-4 of a prior menstrual cycle and anti-mullerian hormone (AMH) \\<15 pmol/L (or \\<2 ng/ml) within prior 12 months of cycle start\n\nAt the time of embryo selection:\n\n-Patients without at least one embryo to transfer.'}, 'identificationModule': {'nctId': 'NCT04976920', 'briefTitle': 'Metabolomics Non Selection Study - Vitrolife Media', 'organization': {'class': 'INDUSTRY', 'fullName': 'Overture Life'}, 'officialTitle': 'Non-selection Trial Comparing Metabolomics to PGT-A Embryo Selection Using Vitrolife G-TL Media', 'orgStudyIdInfo': {'id': 'OLM001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment Group', 'description': 'Patients will undergo a routine IVF cycle. This will include ovarian stimulation, egg retrieval and fertilization of oocytes through intracytoplasmic sperm injection (ICSI). All fertilized oocytes will be cultured up to blastocyst for five to six days.\n\nSpent media will be collected on day 5-6 for all embryos reaching blastocyst on day 5, and on day 6 for those reaching blastocyst on day 6. The spent culture media will be sent to a lab for metabolomic analysis.\n\nFor the embryo transfer, the best morphology blastocyst will be selected for transfer by the New Hope embryologist. The embryo transfer outcome will be compared to the metabolomics result to determine the NPV and PPV of metabolomics vs implantation.', 'interventionNames': ['Diagnostic Test: Overture Metabolomics Embryo Selection']}], 'interventions': [{'name': 'Overture Metabolomics Embryo Selection', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients will have their embryos selected for transfer based on morphology alone. The embryo transfer outcome will be compared to the metabolomics result to determine the NPV and PPV of metabolomics vs implantation.', 'armGroupLabels': ['Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Ariel Ahumada, MD', 'role': 'CONTACT'}, {'name': 'Ariel Ahumada, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Grupo Procrearte', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jose Teruel Lopez', 'role': 'CONTACT'}, {'name': 'Juana Crespo, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Clinical Juana Crespo', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'centralContacts': [{'name': 'Alexander Nadal', 'role': 'CONTACT', 'email': 'alex@overture.life', 'phone': '323-420-6343'}, {'name': 'Sara Cabello', 'role': 'CONTACT', 'email': 'sara@overture.life'}], 'overallOfficials': [{'name': 'Jose Horcajadas, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Overture Life'}, {'name': 'Santiago Munne, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Overture Life'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be presented at industry conferences, and published in peer reviewed journals.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Overture Life', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Clinica Juana Crespo', 'class': 'UNKNOWN'}, {'name': 'Grupo Procrearte', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Jose Horcajadas', 'investigatorAffiliation': 'Overture Life'}}}}