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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Ivirma Madrid
RECRUITING
Madrid
Ivirma Valencia
RECRUITING
Valencia
Contact Information
Primary
MARIA LUISA PARDIÑAS, Pre-Doc
marialuisa.pardiñas@ivirma.com
+34 963.05.90.00
Time Frame
Start Date: 2023-06-29
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 80
Treatments
Active_comparator: SWIM-UP
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.
Experimental: ZYMOT
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.
Related Therapeutic Areas
Sponsors
Collaborators: IVI Madrid
Leads: Instituto Valenciano de Infertilidad, IVI VALENCIA

This content was sourced from clinicaltrials.gov