Infertility (IVF Patients)Spermy01NCT07456397
Development of an AI Platform for the Analysis of Sperm and Prediction of Their Clinical Potential
An observational study of Infertility (IVF Patients) and ICSI, run by Fecundis Lab SL at 5 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Infertility (IVF Patients), ICSI, IVF Outcomes
- What is being tested?
- Swim-up, Density gradient centrifugation and HyperSperm
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 5 sitesSpain
- Study dates
- 18 Mar 2026to Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Men and women undergoing IVF/ICSI treatment at participating fertility clinics.
Who may be able to join
- Ability to provide a semen sample via masturbation
- Semen sample intended for use in an IVF/ICSI cycle
- Urdengoing an IVF/ICSI cycle with partner or donor semen
Who cannot join
- 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:
- Prior participation in this study
- Participation in a clinical trial involving an intervention within the last 3 months
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Spain5 sites, 5 recruiting
- Recruiting
Eugin Barcelona
Barcelona, Barcelona, 08006
Rafael Lafuente, +34933221122, rlafuente@eugin.es
- Recruiting
Fertty
Barcelona, Barcelona, 08010
Mariona Rius Mas, +34937378190, mariona.rius@fertty.com
- Recruiting
CIRH
Barcelona, Barcelona, 08017
Alicia Maqueda, +34932806535, amaqueda@cirh.es
- Recruiting
Fertilab Barcelona
Barcelona, Barcelona, 08017
Sergio Novo Bruña, +34932411414, sergi.novo@fertilab.com
- Recruiting
Natuvitro
Barcelona, Barcelona, 08029
Aïda Pujol Masana, +34936555888, aida@natuvitro.com
About this study
Official title: Development and Validation of an Artificial Intelligence Platform for the Analysis of Sperm Samples and Prediction of Their Clinical Potential
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.
- Being tested
- Swim-up, Density gradient centrifugation, HyperSperm
- Medical subject headings
- Infertility, Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swim-upDevice
Sperm samples will be processed by swim-up technique
Density gradient centrifugationDevice
Sperm samples will be processed by density gradient centrifugation
HyperSpermDevice
Sperm samples will be processed by HyperSperm
| Study group | Role | What they receive |
|---|---|---|
| IVF/ICSI Cycles Using Partner Semen | Couples undergoing IVF/ICSI treatment using ejaculated partner semen Receives: Device: Swim-up; Device: Density gradient centrifugation; Device: HyperSperm | |
| IVF/ICSI Cycles Using Donor Semen | Women undergoing IVF/ICSI treatment using donor semen Receives: Device: Swim-up; Device: Density gradient centrifugation; Device: HyperSperm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to confirmation of clinical pregnancy: approximately 6-8 weeks after embryo transfer.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start18 Mar 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility (IVF Patients)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fecundis Lab SL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mariona Rius Mas, PhD, Principal investigator, Fertty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456397
- Sponsor's protocol ID
- Spermy01
- Acronym
- Spermy01
- Status last verified
- Apr 2026
- First submitted
- 27 Feb 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of an Artificial Intelligence Platform for the Analysis of Sperm Samples and Prediction of Their Clinical Potential
- ClinicalTrials.gov ID
- NCT07456397
- Acronym / sponsor ID
- Spermy01 / Spermy01
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fecundis Lab SLUniversity, hospital or other
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVF/ICSI Cycles Using Partner Semen | – | Device: Swim-up, Device: Density gradient centrifugation, Device: HyperSpermCouples undergoing IVF/ICSI treatment using ejaculated partner semen |
| IVF/ICSI Cycles Using Donor Semen | – | Device: Swim-up, Device: Density gradient centrifugation, Device: HyperSpermWomen undergoing IVF/ICSI treatment using donor semen |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Men and women undergoing IVF/ICSI treatment at participating fertility clinics.
Key inclusion criteria (3 listed)
- Ability to provide a semen sample via masturbation
- Semen sample intended for use in an IVF/ICSI cycle
- Urdengoing an IVF/ICSI cycle with partner or donor semen
Key exclusion criteria (7 listed)
- 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
- Prior participation in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swim-upSperm samples will be processed by swim-up technique | Device | IVF/ICSI Cycles Using Donor Semen, IVF/ICSI Cycles Using Partner Semen |
| Density gradient centrifugationSperm samples will be processed by density gradient centrifugation | Device | IVF/ICSI Cycles Using Donor Semen, IVF/ICSI Cycles Using Partner Semen |
| HyperSpermSperm samples will be processed by HyperSperm | Device | IVF/ICSI Cycles Using Donor Semen, IVF/ICSI Cycles Using Partner Semen |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mariona Rius Mas, PhD principal investigator
Fertty
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility (IVF Patients) and ICSI, run by Fecundis Lab SL at 5 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matias D. Gomez Elias, PhD (+34624174355, mgomezelias@fecundis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive performance of AI models for reproductive outcomes (time frame: Up to confirmation of clinical pregnancy: approximately 6-8 weeks after embryo transfer.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.