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Development of an AI Platform for the Analysis of Sperm and Prediction of Their Clinical Potential

NCT07456397 — Recruiting, 500 participants, Fecundis Lab SL
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Development and Validation of an Artificial Intelligence Platform for the Analysis of Sperm Samples and Prediction of Their Clinical Potential

RegistryNCT07456397, acronym Spermy01
StatusRecruiting
Study typeObservational
Enrollment500 (Estimated)
SponsorFecundis Lab SL (Other)
ConditionsInfertility (IVF Patients), ICSI, IVF Outcomes, Male Infertility, Reproductive Issues
InterventionsSwim-up, Density gradient centrifugation, HyperSperm (Device)
Datesstart 2026-03-18, primary completion 2028-02-01 (estimated), completion 2028-02-01 (estimated), first posted 2026-03-06, last updated 2026-06-12
Locations5 sites in Spain

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
IVF/ICSI Cycles Using Partner SemenDevice: Swim-up; Device: Density gradient centrifugation; Device: HyperSpermCouples undergoing IVF/ICSI treatment using ejaculated partner semen
IVF/ICSI Cycles Using Donor SemenDevice: Swim-up; Device: Density gradient centrifugation; Device: HyperSpermWomen undergoing IVF/ICSI treatment using donor semen
  • Swim-up (Device): Sperm samples will be processed by swim-up technique
  • Density gradient centrifugation (Device): Sperm samples will be processed by density gradient centrifugation
  • HyperSperm (Device): Sperm samples will be processed by HyperSperm

+Outcome measures

Primary outcomes

  • 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.

+Eligibility

Sex: All, ages: 18 Years to 60 Years

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

+Locations (5)

FacilityCityCountryStatus
Eugin BarcelonaBarcelona, BarcelonaSpainRecruiting
FerttyBarcelona, BarcelonaSpainRecruiting
CIRHBarcelona, BarcelonaSpainRecruiting
Fertilab BarcelonaBarcelona, BarcelonaSpainRecruiting
NatuvitroBarcelona, BarcelonaSpainRecruiting

+Investigators

My Notes