Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-01-03 @ 7:22 AM
Study NCT ID:
NCT06384794
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the ZyMōt Sperm Selection Method and Its Effect on Embryo Ploidy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007248', 'term': 'Infertility, Male'}, {'id': 'D009845', 'term': 'Oligospermia'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Embryologists performing IVF/ICSI are blinded to the treatment the sample has undergone. All samples are labeled with the patients Identification number. This is a unique code per patient that does not allow identification of which arm the sample belongs to.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicentric, prospective, experimental study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-25', 'studyFirstSubmitDate': '2024-04-23', 'studyFirstSubmitQcDate': '2024-04-23', 'lastUpdatePostDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EUPLOIDY RATE', 'timeFrame': '1 YEAR', 'description': 'Evaluate euploidy rate and compare it between both groups'}], 'secondaryOutcomes': [{'measure': 'MOBILITY RATE', 'timeFrame': '1 year', 'description': 'Evaluate and compare mobility between both groups'}, {'measure': 'VITALITY RATE', 'timeFrame': '1 year', 'description': 'Evaluate and compare vitality between both groups'}, {'measure': 'DNA FRAGMENTATION RATE', 'timeFrame': '1 YEAR', 'description': 'Evaluate and compare DNA fragmentation between both groups'}, {'measure': 'SPERM RETRIEVAL RATE', 'timeFrame': '1 years', 'description': 'Evaluate and compare sperm retrieval rate between both groups'}, {'measure': 'FERTILIZATION RATE', 'timeFrame': '1 year', 'description': 'Evaluate the effect of ZyMōt on the fertilization rate'}, {'measure': 'USEFUL BLASTOCYS RATE', 'timeFrame': '1 year', 'description': 'To evaluate number of useful blastocyst per number of MII oocyte injected and fertilized.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ZyMöt', 'Sperm fragmentation', 'Embryo development', 'Euploidy'], 'conditions': ['Infertility, Male', 'Sperm Count, Low']}, 'descriptionModule': {'briefSummary': 'It has been described that 11% of men with semen values within the normal range established by the World Health Organization (WHO) have sperm DNA fragmentation. This has been associated with a lower fertilization rate, lower embryo development and, therefore, lower reproductive success. Focusing on the study of the integrity of the male genome can provide us information to diagnose infertility in the couple. The use of conventional sperm selection methods such as swim-up or density gradients has been a great advance in the improvement of male fertility. However, these methods use centrifugation in their protocol, a procedure that has been associated with sperm DNA damage. The ZyMōt is a chip based on microfluidic properties that allows the recovery of spermatozoa with lower DNA fragmentation rate without centrifugation of the semen sample. This new sperm selection method maintains all the advantages of conventional techniques, but decreasing DNA fragmentation associates to sperm recoveries techniques eventually improving reproductive rates. This quality would be beneficial for patients with unexplained infertility, recurrent pregnancy loss or clinical varicocele, factors that have been associated with a higher index of DNA fragmentation. However up to date there is evidence-based data supporting such improvement. The main objective of the present project is to evaluate the ZyMōt as a new non-invasive sperm selection device and to see its impact on the euploidy rate, comparing it with a sperm selection technique that is routinely used in the clinic: swim-up. At the same time, the effect that this new chip may have on sperm and other reproductive variables will be analyzed clinically, and molecularly with immunohistochemical and transcriptomic analyses in order to observe the impact of SDF(sperm DNA fragmentation) at the molecular and genomic level in oocytes with low reparative potential oocytes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Couples undergoing an ICSI cycle with PGT-A (Preimplantational Genetic Test for Aneuploidy).\n* Males over 18 years of age whose semen sample meets the basic conditions predetermined by the ZyMōt Multi 850µL chip.\n* Fresh semen samples.\n* Embryos are to be deposited in a time-lapse incubator.\n* Women over 37 years of age who have obtained in follicular puncture a number of MII oocytes greater than or equal to 4.\n\nExclusion Criteria:\n\n* Males with severe asthenozoospermia (\\<10% progressively motile spermatozoa), globozoospermia (spermatozoa with morphological alterations and lack of acrosome) and/or azoospermia (absence of spermatozoa in the ejaculate).\n* Seminal samples obtained by testicular biopsy.\n* Samples incubated with calcium ionophore.\n* Males and females with previously known abnormal karyotype.\n* Oocytes coming from the oocyte donation program.'}, 'identificationModule': {'nctId': 'NCT06384794', 'acronym': 'ZYMOT2', 'briefTitle': 'Study of the ZyMōt Sperm Selection Method and Its Effect on Embryo Ploidy.', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Valenciano de Infertilidad, IVI VALENCIA'}, 'officialTitle': 'Study of the ZyMōt Sperm Selection Method and Its Effect on Embryo Ploidy.', 'orgStudyIdInfo': {'id': '2211-VLC-157-MD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'SWIM-UP', 'description': 'Half of the sample from the same patient will be processed by the capacitation technique routinely used in the clinic, swim-up: this is a sperm capacitation technique in which the motile spermatozoa in the seminal sample, after centrifugation and incubation, move to the top of the medium. In this way, spermatozoa with good progressive motility will remain in the supernatant.', 'interventionNames': ['Procedure: Swim-up']}, {'type': 'EXPERIMENTAL', 'label': 'ZYMOT', 'description': 'Half of the semen sample will be processed through the ZyMōt® Sperm Separation Device sperm separation chip: This chip based on microfluidic properties will help us to separate and recover the semen sample with an improvement in the quality of the spermatozoa, the capacitated spermatozoa with better motility will be selected.', 'interventionNames': ['Device: Sperm capacitation through the ZyMōt®Sperm Separation Device®']}], 'interventions': [{'name': 'Sperm capacitation through the ZyMōt®Sperm Separation Device®', 'type': 'DEVICE', 'description': 'This chip based on microfluidic properties will help us to separate and recover the semen sample with improved sperm quality. It is composed of two microwells, one initial and one final, and a porous membrane through which the sample will be filtered and the capacitated spermatozoa with better motility will be selected. Syringe 850µL of the initial seminal sample into the first well and 750µL of seminal wash medium into the second well. The device is incubated at 37°C for up to 30 minutes. During this incubation, the sample will travel by microfluidic properties from the first well through the porous membrane to the second well. This membrane will filter those spermatozoa with a higher motility. Thus, at the end of the established incubation time, the medium with the selected spermatozoa from the second well (final well) will be collected with a syringe. After this, the sample will be processed and ready for the following procedures.', 'armGroupLabels': ['ZYMOT']}, {'name': 'Swim-up', 'type': 'PROCEDURE', 'otherNames': ['Sperm capacitation throught swim-up technique'], 'description': 'The swim-up is a sperm capacitation technique in which the motile spermatozoa of the seminal sample, after centrifugation and incubation, move to the upper part of the medium. In this way, spermatozoa with good progressive motility will remain in the supernatant.', 'armGroupLabels': ['SWIM-UP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28023', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'MONICA TORIBIO', 'role': 'CONTACT', 'email': 'IVESMADRID@IVIRMA.COM', 'phone': '+34 651 79 10 00'}, {'name': 'Alberto Pacheco, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lucía Sánchez, MSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ivirma Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '46015', 'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Maria Jose Delossantos, PhD', 'role': 'CONTACT', 'email': 'mariajose.delossantos@ivi.es', 'phone': '34963050900'}, {'name': 'Laura Caracena, Mrs', 'role': 'CONTACT', 'email': 'laura.caracena@ivirma.com', 'phone': '34963050900', 'phoneExt': '11054'}, {'name': 'Maria Jose Delossantos, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'José María Delosantos, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Angel Martín, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'David Ortega, MSs', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ivirma Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'centralContacts': [{'name': 'MARIA LUISA PARDIÑAS, Pre-Doc', 'role': 'CONTACT', 'email': 'marialuisa.pardiñas@ivirma.com', 'phone': '+34 963.05.90.00'}], 'overallOfficials': [{'name': 'MARIA JOSE DE LOS SANTOS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IVIRMA Valencia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Valenciano de Infertilidad, IVI VALENCIA', 'class': 'OTHER'}, 'collaborators': [{'name': 'IVI Madrid', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}