Swim-up: Sperm samples will be processed by swim-up technique
Density gradient centrifugation: Sperm samples will be processed by density gradient centrifugation
HyperSperm: Sperm samples will be processed by HyperSperm
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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
Primary outcome measure(s)
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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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