protocolSection identificationModule nctId: NCT06384794, orgStudyIdInfo id: 2211-VLC-157-MD, briefTitle: Study of the ZyMōt Sperm Selection Method and Its Effect on Embryo Ploidy., acronym: ZYMOT2, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-29, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Instituto Valenciano de Infertilidad, IVI VALENCIA, class: OTHER, collaborators name: IVI Madrid, 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., conditionsModule conditions: Infertility, Male, conditions: Sperm Count, Low, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multicentric, prospective, experimental study., primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, 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., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Sperm capacitation through the ZyMōt®Sperm Separation Device®, interventions name: Swim-up, outcomesModule primaryOutcomes measure: EUPLOIDY RATE, secondaryOutcomes measure: MOBILITY RATE, secondaryOutcomes measure: VITALITY RATE, secondaryOutcomes measure: DNA FRAGMENTATION RATE, secondaryOutcomes measure: SPERM RETRIEVAL RATE, secondaryOutcomes measure: FERTILIZATION RATE, secondaryOutcomes measure: USEFUL BLASTOCYS RATE, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ivirma Madrid, status: RECRUITING, city: Madrid, zip: 28023, country: Spain, contacts name: MONICA TORIBIO, role: CONTACT, phone: +34 651 79 10 00, email: IVESMADRID@IVIRMA.COM, contacts name: Alberto Pacheco, PhD, role: SUB_INVESTIGATOR, contacts name: Lucía Sánchez, MSc, role: SUB_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Ivirma Valencia, status: RECRUITING, city: Valencia, zip: 46015, country: Spain, contacts name: Maria Jose Delossantos, PhD, role: CONTACT, phone: 34963050900, email: mariajose.delossantos@ivi.es, contacts name: Laura Caracena, Mrs, role: CONTACT, phone: 34963050900, phoneExt: 11054, email: laura.caracena@ivirma.com, contacts name: Maria Jose Delossantos, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: José María Delosantos, PhD, role: SUB_INVESTIGATOR, contacts name: Angel Martín, MSc, role: PRINCIPAL_INVESTIGATOR, contacts name: David Ortega, MSs, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False