ICSI, Infertility (IVF Patients), IVF Outcomes, Male Infertility, Reproductive Issues
Conditions
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.
Interventions
DEVICESwim-up
Sperm samples will be processed by swim-up technique
Sperm samples will be processed by density gradient centrifugation
DEVICEHyperSperm
Sperm samples will be processed by HyperSperm
Sponsors
Fecundis Lab SL
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Predictive performance of AI models for reproductive outcomes | 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. |
Countries
Spain
Contacts
CONTACTMatias D. Gomez Elias, PhD
PRINCIPAL_INVESTIGATORMariona Rius Mas, PhD
Fertty
Outcome results
None listed