AI tool to analyze sperm and predict their ability to help IVF/ICSI succeed
Development and Validation of an Artificial Intelligence Platform for the Analysis of Sperm Samples and Prediction of Their Clinical Potential
This project will test an AI platform that analyzes semen samples from men providing sperm for IVF/ICSI to see if it can predict which samples have the best chance of supporting successful IVF/ICSI outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Fecundis Lab SL Academic / other |
| Locations | 5 sites (Barcelona, Barcelona and 4 other locations) |
| Trial ID | NCT07456397 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter observational project using a split-sample design on 500 semen samples collected over 24 months at three Barcelona clinics. Samples will be processed with common sperm-preparation methods (swim-up, density gradient centrifugation, HyperSperm) and analyzed with imaging and laboratory data to train and validate an AI model. No experimental interventions are applied to patients or treatment protocols; the work is conducted in vitro on aliquots of semen intended for IVF/ICSI. The AI will be tested for its ability to predict standard lab metrics and available IVF/ICSI outcome measures where linked clinical data exist.
Who should consider this trial
Good fit: Ideal candidates are men able to provide a semen sample by masturbation that is intended for use in an IVF or ICSI cycle, with the female partner or donor undergoing an IVF/ICSI cycle at the participating centers.
Not a fit: People with a current sexually transmitted infection, a prior diagnosis of hepatitis A/B/C/D or HIV, those not using their semen for an IVF/ICSI cycle, or prior participants in this protocol are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the AI could help embryology labs select sperm more reliably and potentially improve IVF/ICSI success rates while reducing uncertainty in sperm selection.
How similar studies have performed: Similar AI approaches to sperm and embryo analysis have shown promising early results but remain exploratory and not yet widely adopted in clinical practice.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Barcelona, Barcelona and 4 other locations
- Eugin Barcelona — Barcelona, Barcelona, Spain (Recruiting)
- Fertty — Barcelona, Barcelona, Spain (Recruiting)
- Cirh — Barcelona, Barcelona, Spain (Recruiting)
- Fertilab Barcelona — Barcelona, Barcelona, Spain (Recruiting)
- Natuvitro — Barcelona, Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Mariona Rius Mas, PhD — Fertty
- Study coordinator: Matias D. Gomez Elias, PhD
- Email: mgomezelias@fecundis.com
- Phone: +34624174355
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.