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Recruiting NCT07456397

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

— Observational Infertility (IVF Patients) ICSI IVF Outcomes Male Infertility

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Swim-up, Density gradient centrifugation, HyperSperm.
Who it may be relevant to
Registry conditions: Infertility (IVF Patients), ICSI, IVF Outcomes, Male Infertility. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Predictive performance of AI models for reproductive outcomes [Time frame: Up to confirmation of clinical pregnancy: approximately 6-8 weeks after embryo transfer.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 5 centers
  • Eugin Barcelona — Barcelona
  • Fertty — Barcelona
  • CIRH — Barcelona
  • Fertilab Barcelona — Barcelona
  • Natuvitro — Barcelona

Identifiers

NCT: NCT07456397 · Spermy01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗