NCT07456397

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
18mo left

Started Mar 2026

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Mar 2026Feb 2028

First Submitted

Initial submission to the registry

February 27, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

March 18, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

June 12, 2026

Status Verified

April 1, 2026

Enrollment Period

1.9 years

First QC Date

February 27, 2026

Last Update Submit

June 10, 2026

Conditions

IVF OutcomesInfertility (IVF Patients)ICSIMale InfertilityReproductive Issues

Outcome Measures

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.

    Up to confirmation of clinical pregnancy: approximately 6-8 weeks after embryo transfer.

Study Arms (2)

IVF/ICSI Cycles Using Partner Semen

Couples undergoing IVF/ICSI treatment using ejaculated partner semen

Device: Swim-upDevice: Density gradient centrifugationDevice: HyperSperm

IVF/ICSI Cycles Using Donor Semen

Women undergoing IVF/ICSI treatment using donor semen

Device: Swim-upDevice: Density gradient centrifugationDevice: HyperSperm

Interventions

Swim-upDEVICE

Sperm samples will be processed by swim-up technique

IVF/ICSI Cycles Using Donor SemenIVF/ICSI Cycles Using Partner Semen
Density gradient centrifugationDEVICE

Sperm samples will be processed by density gradient centrifugation

IVF/ICSI Cycles Using Donor SemenIVF/ICSI Cycles Using Partner Semen
HyperSpermDEVICE

Sperm samples will be processed by HyperSperm

IVF/ICSI Cycles Using Donor SemenIVF/ICSI Cycles Using Partner Semen

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Men and women undergoing IVF/ICSI treatment at participating fertility clinics.

You may qualify if:

  • Ability to provide a semen sample via masturbation
  • Semen sample intended for use in an IVF/ICSI cycle

You may not qualify if:

  • 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:
  • Urdengoing an IVF/ICSI cycle with partner or donor semen
  • Prior participation in this study
  • Participation in a clinical trial involving an intervention within the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Eugin Barcelona

Barcelona, Barcelona, 08006, Spain

RECRUITING

Fertty

Barcelona, Barcelona, 08010, Spain

RECRUITING

CIRH

Barcelona, Barcelona, 08017, Spain

RECRUITING

Fertilab Barcelona

Barcelona, Barcelona, 08017, Spain

RECRUITING

Natuvitro

Barcelona, Barcelona, 08029, Spain

RECRUITING

MeSH Terms

Conditions

InfertilityInfertility, Male

Interventions

Centrifugation, Density Gradient

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesGenital Diseases, MaleMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

UltracentrifugationCentrifugationInvestigative TechniquesChemistry Techniques, Analytical

Study Officials

  • Mariona Rius Mas, PhD

    Fertty

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matias D. Gomez Elias, PhD

CONTACT

+34624174355mgomezelias@fecundis.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2026

First Posted

March 6, 2026

Study Start

March 18, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

June 12, 2026

Record last verified: 2026-04

Locations

ES(5)