Actively Recruiting
Development and Validation of an Artificial Intelligence Platform for the Analysis of Sperm Samples and Prediction of Their Clinical Potential
Led by Fecundis Lab SL · Updated on 2026-04-13
500
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a prospective, multicenter observational study to develop and validate an artificial intelligence platform that analyzes sperm samples and predicts their potential for successful reproductive outcomes. The study focuses on semen samples from couples undergoing IVF/ICSI treatment, aiming to improve understanding of sperm quality and its relation to clinical pregnancy. The research involves 500 semen samples collected over 24 months in an in vitro setting. Sperm samples will be processed using three different methods: swim-up technique, density gradient centrifugation, and HyperSperm. The study includes two groups: couples using ejaculated partner semen for IVF/ICSI cycles and women undergoing IVF/ICSI treatment with donor semen. There is no intervention on participants, as the study only analyzes samples to develop the AI platform. Participants will provide semen samples intended for IVF/ICSI cycles, with evaluations occurring up to confirmation of clinical pregnancy about 6 to 8 weeks after embryo transfer. Researchers will assess the predictive performance of the AI models regarding reproductive outcomes. The study spans approximately two years, with no direct treatment involved, focusing on sample analysis and outcome prediction.
CONDITIONS
Brief Title
Development of an AI Platform for the Analysis of Sperm and Prediction of Their Clinical Potential
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants able to provide a semen sample via masturbation
- Semen sample intended for use in an IVF/ICSI cycle
- Female participants undergoing an IVF/ICSI cycle with partner or donor semen
- Participants aged between 18 and 60 years
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day
Participants provide semen samples which are processed using swim-up, density gradient centrifugation, or HyperSperm techniques for analysis.
1 visit (in-person)
Duration - Approximately 6 to 8 weeks after embryo transfer
Participants are observed through their IVF/ICSI cycle to evaluate reproductive outcomes following sperm sample analysis.
Follow-up visits as part of routine IVF/ICSI care
Trial Site Locations
Total: 5 locations
1
Eugin Barcelona
Barcelona, Barcelona, Spain, 08006
Actively Recruiting
2
Fertty
Barcelona, Barcelona, Spain, 08010
Actively Recruiting
3
CIRH
Barcelona, Barcelona, Spain, 08017
Actively Recruiting
4
Fertilab Barcelona
Barcelona, Barcelona, Spain, 08017
Actively Recruiting
5
Natuvitro
Barcelona, Barcelona, Spain, 08029
Actively Recruiting
Research Team
M
Matias D. Gomez Elias, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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