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Recruiting NCT07456397

NCT07456397 Development of an AI Platform for the Analysis of Sperm and Prediction of Their Clinical Potential

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Clinical Trial Summary
NCT ID NCT07456397
Status Recruiting
Phase
Sponsor Fecundis Lab SL
Condition Infertility (IVF Patients)
Study Type OBSERVATIONAL
Enrollment 500 participants
Start Date 2026-03-18
Primary Completion 2028-02

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 60 Years
Study Type OBSERVATIONAL
Interventions
Swim-upDensity gradient centrifugationHyperSperm

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 500 participants in total. It began in 2026-03-18 with a primary completion date of 2028-02.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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

Contact & Investigator

Central Contact

Matias D. Gomez Elias, PhD

✉ mgomezelias@fecundis.com

📞 +34624174355

Principal Investigator

Mariona Rius Mas, PhD

PRINCIPAL INVESTIGATOR

Fertty

Frequently Asked Questions

Who can join the NCT07456397 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Infertility (IVF Patients). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07456397 currently recruiting?

Yes, NCT07456397 is actively recruiting participants. Contact the research team at mgomezelias@fecundis.com for enrollment information.

Where is the NCT07456397 trial being conducted?

This trial is being conducted at Barcelona, Spain, Barcelona, Spain, Barcelona, Spain, Barcelona, Spain and 1 additional location.

Who is sponsoring the NCT07456397 clinical trial?

NCT07456397 is sponsored by Fecundis Lab SL. The principal investigator is Mariona Rius Mas, PhD at Fertty. The trial plans to enroll 500 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology