Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07456397

Development of an AI Platform for the Analysis of Sperm 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Infertility (IVF Patients) Genital Diseases Genital Diseases, Male ICSI IVF Outcomes Infertility Infertility, Male Male Infertility Male Urogenital Diseases Reproductive Issues Urogenital Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CIRH, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Swim-up

Device

Sperm samples will be processed by swim-up technique

Density gradient centrifugation

Device

Sperm samples will be processed by density gradient centrifugation

HyperSperm

Device

Sperm samples will be processed by HyperSperm

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Matias D. Gomez Elias, PhD

CONTACT

[email protected]

+34624174355

Sponsors and collaborators

Lead sponsor

Fecundis Lab SL

Other

Registry information

Official study title

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

Acronym: Spermy01

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 6, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.