Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06384794

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

Led by Instituto Valenciano de Infertilidad, IVI VALENCIA · Updated on 2024-04-29

80

Participants Needed

2

Research Sites

78 weeks

Total Duration

On this page

Sponsors

I

Instituto Valenciano de Infertilidad, IVI VALENCIA

Lead Sponsor

I

IVI Madrid

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying male infertility by evaluating a new sperm selection device called the ZyMôt chip. This chip aims to recover sperm with lower DNA fragmentation, which has been linked to reduced fertilization rates and embryo development. The study compares this new microfluidic device to the conventional swim-up sperm selection method, exploring its impact on embryo chromosomal normality (euploidy rate) and examining molecular effects related to sperm DNA quality in couples facing infertility challenges such as unexplained infertility, recurrent pregnancy loss, or varicocele. The trial processes semen samples from male participants using two methods: half of each sample is treated with the routine swim-up technique involving centrifugation and incubation, and the other half is processed using the ZyMôt sperm separation chip, which filters sperm based on motility without centrifugation. The device incubates the sample at body temperature for up to 30 minutes, allowing selection of sperm with better motility. Both methods are then compared for their effects on sperm and reproductive outcomes. Participants undergo assessments including sperm mobility, vitality, DNA fragmentation, retrieval rates, fertilization success, and blastocyst usefulness over one year. Embryos are monitored in a time-lapse incubator, and molecular analyses investigate sperm DNA effects on oocytes with limited repair capacity. The study tracks these outcomes to assess whether the ZyMôt device improves sperm quality and embryo development compared to traditional methods, with the total participation spanning about one year.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Couples undergoing an ICSI cycle with Preimplantational Genetic Test for Aneuploidy (PGT-A)
  • Male participants over 18 years old with semen samples meeting ZyMôt Multi 850µL chip conditions
  • Fresh semen samples provided
  • Embryos to be placed in a time-lapse incubator
  • Female partners over 37 years old with 4 or more mature eggs retrieved (MII oocytes)
Not Eligible

You will not qualify if you...

  • Males with severe asthenozoospermia (less than 10% progressively motile sperm), globozoospermia, or azoospermia
  • Semen samples obtained by testicular biopsy
  • Samples incubated with calcium ionophore
  • Males or females with known abnormal chromosome karyotypes
  • Oocytes from egg donation programs

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Single day procedure

Participants provide fresh semen samples which are processed using two different sperm capacitation techniques: the routine swim-up method and the ZyMōt® Sperm Separation Device to assess sperm quality.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 1 year

Participants are monitored for outcomes related to sperm and embryo quality following sperm processing and fertilization procedures.

Follow-up visits as scheduled during the 1 year period

Trial Site Locations

Total: 2 locations

1

Ivirma Madrid

Madrid, Spain, 28023

Actively Recruiting

2

Ivirma Valencia

Valencia, Spain, 46015

Actively Recruiting

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Research Team

M

MARIA LUISA PARDIÑAS, Pre-Doc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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Frequently Asked Questions

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