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

Last updated: April 25, 2024
Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Overall Status: Active - Recruiting

Phase

N/A

Condition

Infertility

Male Hormonal Deficiencies/abnormalities

Treatment

Swim-up

Sperm capacitation through the ZyMōt®Sperm Separation Device®

Clinical Study ID

NCT06384794
2211-VLC-157-MD
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Couples undergoing an ICSI cycle with PGT-A (Preimplantational Genetic Test forAneuploidy).
  • Males over 18 years of age whose semen sample meets the basic conditions predeterminedby 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 MIIoocytes greater than or equal to 4.

Exclusion

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.

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Swim-up
Phase:
Study Start date:
June 29, 2023
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Ivirma Madrid

    Madrid, 28023
    Spain

    Active - Recruiting

  • Ivirma Valencia

    Valencia, 46015
    Spain

    Active - Recruiting

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