Development of an AI Platform for the Analysis of Sperm and Prediction of Their Clinical Potential
Development and Validation of an Artificial Intelligence Platform for the Analysis of Sperm Samples and Prediction of Their Clinical Potential
Fecundis Lab SL
500 participants
Feb 1, 2026
OBSERVATIONAL
Conditions
Summary
Prospective, multicenter research study with a split-sample design on semen samples, without intervention, to develop an artificial intelligence platform for the analysis of sperm samples and prediction of their clinical potential, in 500 semen samples, in an in vitro study over 24 months.
Eligibility
Inclusion Criteria4
- Male participants:
- Ability to provide a semen sample via masturbation
- Semen sample intended for use in an IVF/ICSI cycle
- Urdengoing an IVF/ICSI cycle with partner or donor semen
Exclusion Criteria7
- Current diagnosis of a sexually transmitted infection (STI)
- Previous diagnosis of hepatitis A, B, C, D, or HIV
- Prior participation in this study
- Participation in a clinical trial involving an intervention within the last 3 months
- Female participants:
- Prior participation in this study
- Participation in a clinical trial involving an intervention within the last 3 months
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Interventions
Sperm samples will be processed by swim-up technique
Sperm samples will be processed by density gradient centrifugation
Sperm samples will be processed by HyperSperm
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07456397