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

Infertility, Male Clinical Trial

— ZYMOT2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06384794
• Other study ID #: 2211-VLC-157-MD
• Status: Recruiting
• Phase: N/A
• Start date: June 29, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Contact: MARIA LUISA PARDIÑAS, Pre-Doc
• Phone: +34 963.05.90.00
• Email: marialuisa.pardiñas[@]ivirma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2026
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ZyMot 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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Oligospermia
• Sperm Count, Low

Intervention

Device:
• Sperm capacitation through the ZyMot®Sperm Separation Device®
This chip based on microfluidic properties will help us to separate and recover the semen sample with improved sperm quality. It is composed of two microwells, one initial and one final, and a porous membrane through which the sample will be filtered and the capacitated spermatozoa with better motility will be selected. Syringe 850µL of the initial seminal sample into the first well and 750µL of seminal wash medium into the second well. The device is incubated at 37°C for up to 30 minutes. During this incubation, the sample will travel by microfluidic properties from the first well through the porous membrane to the second well. This membrane will filter those spermatozoa with a higher motility. Thus, at the end of the established incubation time, the medium with the selected spermatozoa from the second well (final well) will be collected with a syringe. After this, the sample will be processed and ready for the following procedures.

Procedure:
• Swim-up
The swim-up is a sperm capacitation technique in which the motile spermatozoa of the seminal sample, after centrifugation and incubation, move to the upper part of the medium. In this way, spermatozoa with good progressive motility will remain in the supernatant.

Locations

Country	Name	City	State
Spain	Ivirma Madrid	Madrid
Spain	Ivirma Valencia	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA	IVI Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EUPLOIDY RATE	Evaluate euploidy rate and compare it between both groups	1 YEAR
Secondary	MOBILITY RATE	Evaluate and compare mobility between both groups	1 year
Secondary	VITALITY RATE	Evaluate and compare vitality between both groups	1 year
Secondary	DNA FRAGMENTATION RATE	Evaluate and compare DNA fragmentation between both groups	1 YEAR
Secondary	SPERM RETRIEVAL RATE	Evaluate and compare sperm retrieval rate between both groups	1 years
Secondary	FERTILIZATION RATE	Evaluate the effect of ZyMot on the fertilization rate	1 year
Secondary	USEFUL BLASTOCYS RATE	To evaluate number of useful blastocyst per number of MII oocyte injected and fertilized.	1 year