Development of an AI Platform for the Analysis of Sperm and Prediction of Their Clinical Potential (Spermy01)

April 7, 2026 updated by: Fecundis Lab SL

Development and Validation of an Artificial Intelligence Platform for the Analysis of Sperm Samples and Prediction of Their Clinical Potential

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Barcelona
      • Barcelona, Barcelona, Spain, 08006
        • Recruiting
        • Eugin Barcelona
        • Contact:
      • Barcelona, Barcelona, Spain, 08010
      • Barcelona, Barcelona, Spain, 08017
        • Recruiting
        • CIRH
        • Contact:
      • Barcelona, Barcelona, Spain, 08029
        • Recruiting
        • Natuvitro
        • Contact:
      • Barcelona, Barcelona, Spain, 08017
        • Recruiting
        • Fertilab Barcelona
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Men and women undergoing IVF/ICSI treatment at participating fertility clinics.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IVF/ICSI Cycles Using Partner Semen
Couples undergoing IVF/ICSI treatment using ejaculated partner semen
Device: Swim-up
Sperm samples will be processed by swim-up technique
Device: Density gradient centrifugation
Sperm samples will be processed by density gradient centrifugation
Device: HyperSperm
Sperm samples will be processed by HyperSperm
IVF/ICSI Cycles Using Donor Semen
Women undergoing IVF/ICSI treatment using donor semen
Device: Swim-up
Sperm samples will be processed by swim-up technique
Device: Density gradient centrifugation
Sperm samples will be processed by density gradient centrifugation
Device: HyperSperm
Sperm samples will be processed by HyperSperm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive performance of AI models for reproductive outcomes
Time Frame: Up to confirmation of clinical pregnancy: approximately 6-8 weeks after embryo transfer.
Area Under the Receiver Operating Characteristic Curve (AUC) and R² (for continuous outcomes) evaluating the ability of the AI model to predict fertilization rate, blastocyst development rate, and pregnancy outcomes using pseudonymized clinical and semen analysis data.
Up to confirmation of clinical pregnancy: approximately 6-8 weeks after embryo transfer.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fecundis Lab SL

Investigators

  • Principal Investigator: Mariona Rius Mas, PhD, Fertty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

February 27, 2026

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Spermy01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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