Development of an AI Platform for the Analysis of Sperm and Prediction of Their Clinical Potential
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorFecundis Lab SL
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ability to provide a semen sample via masturbation
Semen sample intended for use in an IVF/ICSI cycle
Disqualifiers
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
Trial population
Men and women undergoing IVF/ICSI treatment at participating fertility clinics.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Swim-up
DeviceSperm samples will be processed by swim-up technique
Density gradient centrifugation
DeviceSperm samples will be processed by density gradient centrifugation
HyperSperm
DeviceSperm samples will be processed by HyperSperm
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: IVF/ICSI Cycles Using Partner Semen3 interventions
Group B: IVF/ICSI Cycles Using Donor Semen3 interventions
Trial outcomes
Primary outcomes
1
Predictive performance of AI models for reproductive outcomes
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.
Time frame
Up to confirmation of clinical pregnancy: approximately 6-8 weeks after embryo transfer.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov