Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT06629766
Status:
RECRUITING
Last Update Posted:
2025-04-17
First Post:
2024-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The EPIC Study: Exploring Paternal Age and the Influence on Blastocyst Culture
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Statistician'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-14', 'studyFirstSubmitDate': '2024-10-03', 'studyFirstSubmitQcDate': '2024-10-03', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blastulation Rate per Mature Oocyte (M2)', 'timeFrame': 'approximately 1 week post oocyte retrieval procedure', 'description': 'count of blastocyst stage embryos per M2 count'}], 'secondaryOutcomes': [{'measure': 'Fertilization Rate', 'timeFrame': 'approximately 24 hours post oocyte retrieval procedure', 'description': 'count of fertilized zygotes (2 pronuclei (2PN)) per M2 count'}, {'measure': 'Blastulation Rate per 2PN', 'timeFrame': 'approximately 1 week post oocyte retrieval procedure', 'description': 'count of blastocyst stage embryos per 2PN'}, {'measure': 'Blastocyst Morphology using Modified Gardner Scale', 'timeFrame': 'approximately 1 week post oocyte retrieval procedure', 'description': 'Morphology Grade at time of trophectoderm biopsy and vitrification. Expansion 1-6. Inner cell mass and trophectoderm graded A-D.'}, {'measure': 'Ploidy rates', 'timeFrame': 'approximately 2 weeks post blastocyst trophectoderm biopsy', 'description': 'Rates of whole chromosome negative and positive preimplantation genetic testing for aneuploidy (PGT-A) results per blastocyst'}, {'measure': 'Ongoing pregnancy rate', 'timeFrame': '6 weeks post embryo transfer', 'description': 'rate of ongoing pregnancy at 8-9 weeks gestational age when discharged to obstetrician'}, {'measure': 'Pregnancy Loss Rates', 'timeFrame': '1 day to 7 months post positive beta human chorionic gonadotrophin', 'description': 'a loss of pregnancy (either biochemical or clinical)'}, {'measure': 'Live birth rate', 'timeFrame': 'approximately 7 months after discharge to obstetrician', 'description': 'rate of live born infants'}, {'measure': 'Sperm DNA Fragmentation', 'timeFrame': 'approximately 1-3 hours post intracytoplasmic sperm injection procedure', 'description': 'Sperm DNA Fragmentation will be run on remnant samples'}, {'measure': 'Positive beta human chorionic gonadotrophin (bhcg)', 'timeFrame': '7-10 days post embryo transfer', 'description': 'positive pregnancy test with bhcg \\>5mUI/mL'}, {'measure': 'Embryological Efficiency', 'timeFrame': 'same day as ICSI procedure', 'description': 'Sperm prep time (Time from embryologist possession of sample to completion of prep procedure and ICSI start), benchtop time, ICSI procedural time'}, {'measure': 'Embryology Questionnaire', 'timeFrame': 'upon primary outcome completion in approximately 18 months', 'description': 'Gain perspectives from lab personnel related to likeability, ease of use and efficiency between the two devices'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['microfluidic', 'density grade centrifugation', 'sperm selection', 'paternal age', 'sperm DNA fragmentation', 'Zymot'], 'conditions': ['Infertility (IVF Patients)', 'Oocyte Competence', 'Sperm DNA Fragmentation', 'Paternal Age', 'Sperm Selection']}, 'descriptionModule': {'briefSummary': 'This study aims to assess the effect of age of the male partner and the reproductive ability of sperm prepared via sperm selection devices (Zymot) compared to routine embryologist selected sperm after density gradient centrifugation (DGC) preparation for intracytoplasmic sperm injection (ICSI) in patients undergoing in vitro fertilization treatment (IVF) of their infertility.', 'detailedDescription': 'In this study, we aim to determine the clinical utility of the Zymot sperm selection methodology for ICSI, while also accounting for paternal age. This study will be a prospective, split cohort, randomized, control trial comparing the routine standard of DGC sperm preparation for ICSI versus sperm prepared via Zymot for ICSI. Embryology parameters, ploidy status, DNA fragmentation and clinical pregnancy outcomes will be assessed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '41 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing first IVF cycle\n* Electing single embryo transfer\n* Electing PGT-A of their embryos\n* Female partners age \\<42 years old at start of VOR cycle, but \\>18 years old.\n* AMH ≥ 1.2 ng/mL\n* AFC ≥ 8\n* FSH ≤ 12IU/L\n* At least 4 mature oocytes (M2s) retrieved at the VOR procedure in order to randomize\n* Intention to transfer the morphological best quality, euploid, embryo at the frozen embryo transfer procedure\n\nExclusion Criteria:\n\n* Contraindication to IVF\n* Clinical indication for preimplantation genetic testing (i.e., screening for single gene disorder, chromosomal translocation, or any other disorders requiring a more detailed embryo genetic analysis)\n* Male partner with azoospermia or oligozoospermia (\\<500,000 total motile spermatozoa on the most recent semen analysis within one year of enrollment)\n* Planned for previously cryopreserved sperm to be used for ICSI\n* Donor sperm\n* Male partner with Y-chromosome microdeletion\n* Male partner with any Karyotype other than 46,XY\n* Male partner requiring surgically obtained sperm either via testicular or epididymal retrieval procedures\n* Uncorrected hydrosalpinges that communicate with the endometrial cavity\n* Endometrial Insufficiency, as defined by a prior cycle with maximal endometrial thickness \\<6mm,), or persistent endometrial fluid\n* Donor oocyte or embryo cycles\n* Gestational carriers'}, 'identificationModule': {'nctId': 'NCT06629766', 'acronym': 'EPIC', 'briefTitle': 'The EPIC Study: Exploring Paternal Age and the Influence on Blastocyst Culture', 'organization': {'class': 'OTHER', 'fullName': 'Reproductive Medicine Associates of New Jersey'}, 'officialTitle': 'The EPIC Study: Exploring Paternal Age and the Influence on Blastocyst Culture', 'orgStudyIdInfo': {'id': '2405-BRG-141-KB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oocytes inseminated by sperm prepared by a microfluidic (Zymot) sperm preparation device', 'description': 'Half of the mature oocytes will be randomly allocated to receive sperm prepared by the microfluidic (Zymot) sperm preparation device. This sperm will be used by the embryologist for the ICSI procedure.', 'interventionNames': ['Device: Microfluidic sperm separation device']}, {'type': 'OTHER', 'label': 'Oocytes inseminated by sperm prepared via density grade centrifugation', 'description': 'The other half of the mature oocytes will be allocated to receive sperm prepared by DGC. This sperm will be used by the embryologist for the ICSI procedure.', 'interventionNames': ['Other: Density grade centrifugation']}], 'interventions': [{'name': 'Microfluidic sperm separation device', 'type': 'DEVICE', 'otherNames': ['Zymot'], 'description': "An aliquot of 850ul will be used for the Zymot sperm selection device. The sperm processing via Zymot will be per manufacturer's guidelines", 'armGroupLabels': ['Oocytes inseminated by sperm prepared by a microfluidic (Zymot) sperm preparation device']}, {'name': 'Density grade centrifugation', 'type': 'OTHER', 'description': '5ul of the ejaculated sample will be assessed for DGC via Makler assessment. If the sample for DGC is adequate per lab standard operating procedures, then routine DGC sperm preparation and embryologist sperm selection for the ICSI procedure will occur.', 'armGroupLabels': ['Oocytes inseminated by sperm prepared via density grade centrifugation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Reproductive Medicine Associates of New Jersey', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}], 'centralContacts': [{'name': 'Caroline Clinical Research Nurse, BSN, RN', 'role': 'CONTACT', 'email': 'clinicalresearchteam@ivirma.com', 'phone': '973-656-2841'}, {'name': 'Christine Director of Research Operations, MS, BSN, RN', 'role': 'CONTACT', 'email': 'clinicalresearchteam@ivirma.com', 'phone': '973-656-2841'}], 'overallOfficials': [{'name': 'Kassie Bollig, MD, MSCE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Reproductive Medicine Associates of New Jersey'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Reproductive Medicine Associates of New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}