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Study of the ZyMōt Sperm Selection Method and Its Effect on Embryo Ploidy.

RecruitingNAAges 18 Years - anyAllInstituto Valenciano de Infertilidad, IVI VALENCIA
NCT06384794 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 th

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📋 Eligibility rules (as published)
Inclusion Criteria: * Couples undergoing an ICSI cycle with PGT-A (Preimplantational Genetic Test for Aneuploidy). * Males over 18 years of age whose semen sample meets the basic conditions predetermined by the ZyMōt Multi 850µL chip. * Fresh semen samples. * Embryos are to be deposited in a time-lapse incubator. * Women over 37 years of age who have obtained in follicular puncture a number of MII oocytes greater than or equal to 4. Exclusion Criteria: * 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). * Seminal samples obtained by testicular biopsy. * Samples incubated with calcium ionophore. * Males and females with previously known abnormal karyotype. * Oocytes coming from the oocyte donation program.
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What it tests

  • Sperm capacitation through the ZyMōt®Sperm Separation Device®
  • Swim-up
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Where

2 sites
Ivirma Madrid
Madrid, Spain
Ivirma Valencia
Valencia, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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