---
title: Development of an AI Platform for the Analysis of Sperm and Prediction of Their Clinical Potential
nct_id: NCT07456397
overall_status: RECRUITING
sponsor: Fecundis Lab SL
study_type: OBSERVATIONAL
primary_condition: Infertility (IVF Patients)
countries: Spain
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07456397.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07456397"
ct_last_update_post_date: 2026-04-13
last_seen_at: "2026-05-12T06:07:15.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Development of an AI Platform for the Analysis of Sperm and Prediction of Their Clinical Potential

**Official Title:** Development and Validation of an Artificial Intelligence Platform for the Analysis of Sperm Samples and Prediction of Their Clinical Potential

**NCT ID:** [NCT07456397](https://clinicaltrials.gov/study/NCT07456397)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 500
- **Lead Sponsor:** Fecundis Lab SL
- **Conditions:** Infertility (IVF Patients), ICSI, IVF Outcomes, Male Infertility, Reproductive Issues
- **Start Date:** 2026-03-18
- **Completion Date:** 2028-02
- **CT.gov Last Update:** 2026-04-13

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 60 Years
- **Sex:** ALL
- **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
```

## Arms

- **IVF/ICSI Cycles Using Partner Semen** — Couples undergoing IVF/ICSI treatment using ejaculated partner semen
- **IVF/ICSI Cycles Using Donor Semen** — Women undergoing IVF/ICSI treatment using donor semen

## Interventions

- **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

## Primary Outcomes

- **Predictive performance of AI models for reproductive outcomes** _(time frame: 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.

## Locations (5)

- Eugin Barcelona, Barcelona, Barcelona, Spain — _RECRUITING_
- Fertty, Barcelona, Barcelona, Spain — _RECRUITING_
- CIRH, Barcelona, Barcelona, Spain — _RECRUITING_
- Fertilab Barcelona, Barcelona, Barcelona, Spain — _RECRUITING_
- Natuvitro, Barcelona, Barcelona, Spain — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.eugin barcelona|barcelona|barcelona|spain` — added _(2026-05-12)_
- `locations.fertty|barcelona|barcelona|spain` — added _(2026-05-12)_
- `locations.cirh|barcelona|barcelona|spain` — added _(2026-05-12)_
- `locations.fertilab barcelona|barcelona|barcelona|spain` — added _(2026-05-12)_
- `locations.natuvitro|barcelona|barcelona|spain` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT07456397.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT07456397*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*