Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-03-16 @ 6:31 PM
Study NCT ID:
NCT05332769
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-07
First Post:
2022-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cumulus Cell Mitochondrial Activity as a Non-invasive Marker of Embryo Quality (FLIM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Cumulus cell of oocyte'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2022-04-10', 'studyFirstSubmitQcDate': '2022-04-10', 'lastUpdatePostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Live birth rate after one frozen embryo transfer cycle', 'timeFrame': "After 24 week's gestation", 'description': "The birth of at least one newborn, after 24 week's gestation that exhibits any sign of life, such as respiration, heartbeat, umbilical pulsation, or movement of voluntary muscles"}], 'secondaryOutcomes': [{'measure': 'Positive pregnancy test', 'timeFrame': 'At 2 weeks after embryo placement', 'description': 'Positive pregnancy test is defined as a serum human chorionic gonadotropin level greater than 25 mIU/mL after2 weeks after embryo placement of the first transfer'}, {'measure': 'Clinical pregnancy', 'timeFrame': "7 week's gestation", 'description': "The presence of at least one gestational sac on ultrasound at 7 week's gestation with the detection of heartbeat activity, after the completion of the first transfer"}, {'measure': 'Implantation rate', 'timeFrame': '3 weeks after the first transfer', 'description': 'Implantation rate is defined as the number of gestational sacs per number of embryos transferred 3 weeks after the first transfer'}, {'measure': 'Ongoing pregnancy', 'timeFrame': 'At 10 weeks after embryo placement', 'description': "Having at least 1 gestational sac on ultrasound at 12 weeks' gestation with heart beat activity"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cumulus cell', 'Day 5/6 frozen embryo', 'Fluorescence lifetime imaging microscopy', 'FLIM', 'IVF/ICSI'], 'conditions': ['IVF/ICSI', 'Frozen Embryo Transfer', 'Cumulus Cell', 'Fluorescence Lifetime Imaging Microscopy']}, 'referencesModule': {'references': [{'pmid': '30593441', 'type': 'RESULT', 'citation': 'Fauser BC. Towards the global coverage of a unified registry of IVF outcomes. Reprod Biomed Online. 2019 Feb;38(2):133-137. doi: 10.1016/j.rbmo.2018.12.001. Epub 2018 Dec 14. No abstract available.'}, {'pmid': '17222699', 'type': 'RESULT', 'citation': 'Dumollard R, Duchen M, Carroll J. The role of mitochondrial function in the oocyte and embryo. Curr Top Dev Biol. 2007;77:21-49. doi: 10.1016/S0070-2153(06)77002-8.'}, {'pmid': '27562289', 'type': 'RESULT', 'citation': "May-Panloup P, Boucret L, Chao de la Barca JM, Desquiret-Dumas V, Ferre-L'Hotellier V, Moriniere C, Descamps P, Procaccio V, Reynier P. Ovarian ageing: the role of mitochondria in oocytes and follicles. Hum Reprod Update. 2016 Nov;22(6):725-743. doi: 10.1093/humupd/dmw028. Epub 2016 Aug 25."}, {'pmid': '25719756', 'type': 'RESULT', 'citation': 'Babayev E, Seli E. Oocyte mitochondrial function and reproduction. Curr Opin Obstet Gynecol. 2015 Jun;27(3):175-81. doi: 10.1097/GCO.0000000000000164.'}, {'pmid': '29708901', 'type': 'RESULT', 'citation': 'Scott R 3rd, Zhang M, Seli E. Metabolism of the oocyte and the preimplantation embryo: implications for assisted reproduction. Curr Opin Obstet Gynecol. 2018 Jun;30(3):163-170. doi: 10.1097/GCO.0000000000000455.'}, {'pmid': '26758390', 'type': 'RESULT', 'citation': "Chakraborty S, Nian FS, Tsai JW, Karmenyan A, Chiou A. Quantification of the Metabolic State in Cell-Model of Parkinson's Disease by Fluorescence Lifetime Imaging Microscopy. Sci Rep. 2016 Jan 13;6:19145. doi: 10.1038/srep19145."}, {'pmid': '22621335', 'type': 'RESULT', 'citation': 'Becker W. Fluorescence lifetime imaging--techniques and applications. J Microsc. 2012 Aug;247(2):119-36. doi: 10.1111/j.1365-2818.2012.03618.x. Epub 2012 May 24.'}, {'pmid': '30446247', 'type': 'RESULT', 'citation': 'Sanchez T, Wang T, Pedro MV, Zhang M, Esencan E, Sakkas D, Needleman D, Seli E. Metabolic imaging with the use of fluorescence lifetime imaging microscopy (FLIM) accurately detects mitochondrial dysfunction in mouse oocytes. Fertil Steril. 2018 Dec;110(7):1387-1397. doi: 10.1016/j.fertnstert.2018.07.022. Epub 2018 Nov 14.'}, {'pmid': '30691624', 'type': 'RESULT', 'citation': 'Sanchez T, Zhang M, Needleman D, Seli E. Metabolic imaging via fluorescence lifetime imaging microscopy for egg and embryo assessment. Fertil Steril. 2019 Feb;111(2):212-218. doi: 10.1016/j.fertnstert.2018.12.014.'}], 'seeAlsoLinks': [{'url': 'https://www.hfea.gov.uk/about-us/publications/research-and-data/fertility-treatment-2019-trends-and-figures/', 'label': 'T. H. F. and E. A. (HFEA), "Fertility treatment 2019: trends and figures," 2021.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to test the extent of association of FLIM parameters of cumulus cells with clinical outcomes (clinical pregnancy, ongoing pregnancy at 12 weeks, and live birth) of the embryos that result from the enclosed oocytes.', 'detailedDescription': 'This study aims to test the extent of association of FLIM parameters of cumulus cells with clinical outcomes (clinical pregnancy, ongoing pregnancy at 12 weeks, and live birth) of the embryos that result from the enclosed oocytes.\n\nParticipants will be consented to and pre-signed following standard regimens of IVFMD, My Duc Hospital and IVFMD PN, My Duc Phu Nhuan Hospital. The standard is for patients with at least 8 follicles ≥ 10 mm on ultrasonography at the induced ovulation date.\n\nCumulus samples (CCs) will be collected following the protocol on the day of oocyte pick up (OPU), being assigned with the same number as the oocyte from which it was collected, and vitrified with a Cryotech kit until FLIM measurements are performed.\n\nInsemination will be performed by using ICSI, 3 - 4 hours after oocyte retrieval. A sample of CCs will be sliced off the cumulus mass of each oocyte judged to be mature based on the cumulus mass disposition (absence of tight corona layers). The remaining cumulus cells will be stripped from the OCCs using hyaluronidase. Only mature oocytes will be inseminated.\n\nThe fertilization check will be performed under an inverted microscope for a period of 16-18 hours after insemination. On day 3, embryo evaluation will be performed at a fixed time point 66±2 hours after fertilization and, for day 5/6 transfers at 116±2 hours or 140±2 hours, respectively, using the Istanbul consensus. Freeze-all strategy for day 5 embryo will be applied and the first frozen embryo transfer cycle is single embryo transfer.\n\nOn the other hand, the investigators will stratify embryos into two groups based on the measured FLIM parameters from their associated cumulus cells, corresponding to the "high" 35% and "low" 65% of metabolic scores.\n\nThe investigators aim for embryos in the "high" metabolic scoring group to have a 10% higher live birth rate than controls. Assuming a current live birth rate of 32%, this corresponds to a hoped-for 42% live birth rate in the "high" group (and a 25% live birth rate in the "low" group). A total of 450 patients are required to detect an effect of this size (power 0.90, two-sided alpha 5%).\n\nThe primary endpoint of the study will be the live birth rate after the first embryo transfer of the started treatment cycle.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All Vietnamese infertile women who have IVF/ICSI cycle with at least 8 follicles ≥ 10 mm on ultrasonography at induced ovulation date agreed to freeze-all day 5-6 embryos at IVFMD and IVFMD PN will be enrolled in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having any number of IVF/ICSI attempts\n* Ovarian stimulation with any stimulation protocol\n* Patients with at least 8 follicles ≥ 10 mm on ultrasonography at induced ovulation date\n* Agreed to freeze-all day 5-6 embryos\n* Agreed to have a single day 5-6 embryo transfer.\n* Agreed to participate in the research (signed the consent form)\n\nExclusion Criteria:\n\n* In vitro maturation (IVM) cycles\n* Cycles using testicular biopsy or epididymal sperm\n* Cycles not having an oocyte freeze-all cycle\n* Cycles using standard insemination\n* Participating in another research'}, 'identificationModule': {'nctId': 'NCT05332769', 'briefTitle': 'Cumulus Cell Mitochondrial Activity as a Non-invasive Marker of Embryo Quality (FLIM)', 'organization': {'class': 'OTHER', 'fullName': 'Mỹ Đức Hospital'}, 'officialTitle': 'Cumulus Cell Mitochondrial Activity as a Non-invasive Marker of Embryo Quality', 'orgStudyIdInfo': {'id': '11/21/DD/BVMD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Infertile women have IVF/ICSI cycle', 'description': 'All Vietnamese infertile women who have IVF/ICSI cycle with at least 8 follicles ≥ 10 mm on ultrasonography at induced ovulation date agreed to freeze-all day 5-6 embryos at IVFMD and IVFMD PN will be enrolled in the study.', 'interventionNames': ['Genetic: FLIM parameters']}], 'interventions': [{'name': 'FLIM parameters', 'type': 'GENETIC', 'otherNames': ['fluorescence lifetime imaging microscopy'], 'description': 'Cumulus samples (CCs) will be collected following the protocol on the day of oocyte pick up (OPU). CCs are frozen by the cryo-tech method, then stored in liquid nitrogen at -196oC. Information of CC samples and processed date/time is recorded. After all, samples are collected, they will be transferred to The Needleman Lab, Northwest Lab Building 359,52 Oxford Street Cambridge MA 02138 to measure mitochondria metabolism using FLIM.', 'armGroupLabels': ['Infertile women have IVF/ICSI cycle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70000', 'city': 'Ho Chi Minh City', 'state': 'Ho Chi Minh City', 'country': 'Vietnam', 'facility': 'My Duc Hospital', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}], 'overallOfficials': [{'name': 'Tuong M Ho, MD, MCE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mỹ Đức Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mỹ Đức Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Needleman Lab, Northwest Lab Building 359,52 Oxford Street Cambridge MA 02138.', 'class': 'UNKNOWN'}, {'name': 'Harvard University Faculty of Medicine', 'class': 'OTHER'}, {'name': 'Hospital Foch, Suresnes, France.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}