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NCT06384794: ZYMOT2
Study of the ZyMōt Sperm Selection Method and Its Effect on Embryo Ploidy.
NA trial testing Sperm capacitation through the ZyMōt®Sperm Separation Device® in Infertility, Male in 80 participants. Currently enrolling.
1 July 2025
Quick facts
| Lead sponsor | Instituto Valenciano de Infertilidad, IVI VALENCIA |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | diagnostic |
| Enrollment | 80 |
| Start date | 29 June 2023 |
| Primary completion | 1 July 2025 |
| Estimated completion | 31 December 2026 |
| Sites | 2 locations across Spain |
Drugs / interventions tested
- Sperm capacitation through the ZyMōt®Sperm Separation Device®
- Swim-up
Conditions studied
- Infertility, Male — all drugs for Infertility, Male →
- Sperm Count, Low — all drugs for Sperm Count, Low →
Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA — full company profile →
Who can join
18 and older, any sex, with Infertility, Male or Sperm Count, Low. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06384794
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06384794 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Instituto Valenciano de Infertilidad, IVI VALENCIA
- Last refreshed: 29 April 2024
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