RecruitingNot Applicable

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

Spain500 participantsStarted 2026-03-18

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Predictive performance of AI models for reproductive outcomes

Timeframe: Up to confirmation of clinical pregnancy: approximately 6-8 weeks after embryo transfer.

Trial details

NCT IDNCT07456397

SponsorFecundis Lab SL

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-02

Contact for this trial

Matias D. Gomez Elias, PhD

+34624174355 mgomezelias@fecundis.com

View on ClinicalTrials.gov More Infertility (IVF Patients) trials