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