AI tool to analyze sperm and predict their ability to help IVF/ICSI succeed
Official title: Development and Validation of an Artificial Intelligence Platform for the Analysis of Sperm Samples and Prediction of Their Clinical Potential
Run by Fecundis Lab SL · NCT07456397 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Fecundis Lab SL Academic / other |
| Locations | 5 sites (Barcelona, Barcelona and 4 other locations) |
| Status | Recruiting |
| Started | March 18, 2026 |
| Main results expected | February 2028 |
| Study ends | February 2028 |
| Registry record updated | June 12, 2026 |
| Trial ID | NCT07456397 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Similar AI approaches to sperm and embryo analysis have shown promising early results but remain exploratory and not yet widely adopted in clinical practice.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Biobank for male infertility specimens
This study is collecting leftover sperm and tissue samples from men who have had fertility treatments to help improve understanding and treatment of male infertility in the future.
-
Evaluating a new method for sperm capacitation
This study is testing a new method called HyperSperm to see if it can improve sperm quality for men who are having trouble with fertility.
-
Differential Granulosa Cell Transcriptome Profiling to Predict Ongoing Pregnancy
Aiming to see if differences in granulosa cell gene activity can predict ongoing pregnancy in IVF and oocyte donation with PGT-A.
-
Dual Trigger vs HCG Trigger for Final Maturation in Normal Responders
In normal responders undergoing ICSI cycles, this study tests whether using a dual trigger (GnRH agonist plus hCG) improves outcomes compared with the standard hCG trigger.
-
Predicting pregnancy outcomes after assisted reproduction using a machine-learning model
A machine-learning model will be tested to see if early beta-hCG levels can predict live birth and identify pregnancies at risk after IVF or FET (with exploratory look at IUI).
-
Detoxify for IVF: Cutting Everyday Pollutants to Help Infertility
This study tests a guide to help IVF patients reduce everyday environmental pollutants and sees if it lowers chemical exposure in urine, blood, and follicular fluid.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.