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Recruiting NCT07456397

Development of an AI Platform for the Analysis of Sperm and Prediction of Their Clinical Potential

Trial Parameters

Condition Infertility (IVF Patients)
Sponsor Fecundis Lab SL
Study Type OBSERVATIONAL
Phase N/A
Enrollment 500
Sex ALL
Min Age 18 Years
Max Age 60 Years
Start Date 2026-02
Completion 2028-02
Interventions
Swim-upDensity gradient centrifugationHyperSperm

Brief 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 Criteria

Male participants: Inclusion Criteria: * Ability to provide a semen sample via masturbation * Semen sample intended for use in an IVF/ICSI cycle Exclusion Criteria: * 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: Inclusion Criteria: * Urdengoing an IVF/ICSI cycle with partner or donor semen Exclusion Criteria: * Prior participation in this study * Participation in a clinical trial involving an intervention within the last 3 months

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