Functional Development and Clinical Validation of a Diagnostic Tool Based on Artificial Intelligence for the Assessment of Sperm Quality and the Selection of the Optimal In Vitro Fertilisation (IVF) Treatment

Not yet recruitingOBSERVATIONAL
Enrollment

200

Participants

Timeline

Start Date

November 30, 2025

Primary Completion Date

November 30, 2027

Study Completion Date

November 30, 2027

Conditions
Infertility (IVF Patients)Male FertilitySperm Selection
Interventions
DIAGNOSTIC_TEST

Sperm sellection

Small aliquots of 100 fresh human semen samples will be analysed using the SwimCount™ Harvester system, a CE-marked microfluidic technology patented by MCount and designed for routine clinical use.

DIAGNOSTIC_TEST

DIAGNOSIS TOOL

"The diagnostic tool developed will be validated by analyzing small aliquots of 100 additional fresh semen samples processed with the integrated microfluidic system (SwimCount™ Harvester) and the CASA system with artificial intelligence. To evaluate the diagnostic efficiency of the tool, the results obtained from the semen quality analysis will be compared with those obtained from the analysis of these samples when processed using the reference technique, based on conventional methods employed by fertility specialists. Finally, to determine the effectiveness of the developed tool, the clinical results obtained from assisted reproduction treatment will be compared with the diagnosis predicted by the tool, with the aim of evaluating its predictive capacity.~Translated with DeepL.com (free version)"

Trial Locations (1)

46015

IVI Valencia, Valencia

All Listed Sponsors
lead

Instituto Valenciano de Infertilidad, IVI VALENCIA

OTHER

NCT07185984 - Functional Development and Clinical Validation of a Diagnostic Tool Based on Artificial Intelligence for the Assessment of Sperm Quality and the Selection of the Optimal In Vitro Fertilisation (IVF) Treatment | Biotech Hunter | Biotech Hunter