ZyMōt sperm selection method's effect on embryo quality
Study of the ZyMōt Sperm Selection Method and Its Effect on Embryo Ploidy.
NA · Instituto Valenciano de Infertilidad, IVI VALENCIA · NCT06384794
This study is testing a new way to select sperm to see if it can help couples undergoing IVF have better embryo quality and higher chances of pregnancy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto Valenciano de Infertilidad, IVI VALENCIA (other) |
| Locations | 2 sites (Madrid and 1 other locations) |
| Trial ID | NCT06384794 on ClinicalTrials.gov |
What this trial studies
This study evaluates the ZyMōt Sperm Selection Method, which utilizes microfluidic technology to select sperm with lower DNA fragmentation without the use of centrifugation. It aims to improve fertilization rates and embryo development in couples undergoing ICSI with Preimplantational Genetic Testing for Aneuploidy (PGT-A). By comparing this method to conventional sperm selection techniques, the study seeks to determine its effectiveness in enhancing reproductive success. The study will involve fresh semen samples from eligible male participants and will monitor embryo development in a time-lapse incubator.
Who should consider this trial
Good fit: Ideal candidates include couples undergoing ICSI with PGT-A, where the male partner is over 18 and has a suitable semen sample.
Not a fit: Patients with severe sperm motility issues, certain sperm morphological abnormalities, or those using donor oocytes may not benefit from this study.
Why it matters
Potential benefit: If successful, this method could significantly improve embryo quality and increase the chances of successful pregnancies for couples facing infertility.
How similar studies have performed: While conventional sperm selection methods have shown success, the ZyMōt method is a novel approach that has not been extensively tested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Madrid and 1 other locations
- Ivirma Madrid — Madrid, Spain (RECRUITING)
- Ivirma Valencia — Valencia, Spain (RECRUITING)
Study contacts
- Principal investigator: MARIA JOSE DE LOS SANTOS, PhD — IVIRMA Valencia
- Study coordinator: MARIA LUISA PARDIÑAS, Pre-Doc
- Email: marialuisa.pardiñas@ivirma.com
- Phone: +34 963.05.90.00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infertility, Male, Sperm Count, Low, ZyMöt, Sperm fragmentation, Embryo development, Euploidy