Reproductive IssuesHyperSperm01NCT06742437
Efficacy and Safety of a New Sperm Capacitation Method
An observational study of Reproductive Issues and Male Infertility, run by Fecundis Lab SL at 4 sites in Spain.
Trial summary
Prospective, multicenter research study with a split-sample design on semen samples, without intervention, to evaluate the efficacy and safety of HyperSperm, a new sperm capacitation method, in 300 semen samples with various characteristics and abnormalities, in an in vitro study over 12 months. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Reproductive Issues, Male Infertility, Asthenozoospermia
- What is being tested?
- Standard sperm preparation and HyperSperm
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 4 sitesSpain
- Study dates
- 14 Jan 2025to Sep 2026
- 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
- Men only
- Healthy volunteers accepted
- Adult
Study population: Men attending fertility clinics who provide a semen sample with normal parameters (normozoospermia), or present a male factor (asthenozoospermia, oligozoospermia, teratozoospermia, or a combination thereof).
Who may be able to join
- Ability to provide a semen sample via masturbation
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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain4 sites, 4 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
Karinna Lattes, +34932806535, klattes@cirh.es
- Recruiting
Natuvitro
Barcelona, Barcelona, 08029
Raul Noblom Artigues, +34936555888, raul@natuvitro.com
About this study
Official title: Efficacy and Safety of a New Sperm Capacitation Method: a Prospective in Vitro Study on Semen Samples
Prospective, multicenter research study with a split-sample design on semen samples, without intervention, to evaluate the efficacy and safety of HyperSperm, a new sperm capacitation method, in 300 semen samples with various characteristics and abnormalities, in an in vitro study over 12 months.
- Conditions
- Reproductive Issues, Male Infertility, Asthenozoospermia, Oligozoospermia, Teratozoospermia
- Being tested
- Standard sperm preparation, HyperSperm
- Medical subject headings
- Infertility, Male, Asthenozoospermia, Oligospermia, Teratozoospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard sperm preparationDevice
Sperm samples in the control group will undergo traditional processing
HyperSpermDevice
Sperm samples in the experimental group will undergo product-specific processing
| Study group | Role | What they receive |
|---|---|---|
| Normozoospermic | Semen samples with normal sperm parameters as defined by the World Health Organization guidelines (e.g., normal sperm concentration, motility, and morphology). Receives: Device: Standard sperm preparation; Device: HyperSperm | |
| Teratozoospermic | Semen samples with abnormal sperm morphology, where the percentage of morphologically normal sperm is below the threshold set by the World Health Organization (i.e., 4%). Receives: Device: Standard sperm preparation; Device: HyperSperm | |
| Asthenozoospermic | Semen samples characterized by reduced sperm motility, where the percentage of progressive motile sperm is below the threshold set by the World Health Organization (i.e., 32%). Receives: Device: Standard sperm preparation; Device: HyperSperm | |
| Oligozoospermic | Semen samples with a low sperm concentration, below the World Health Organization reference value (i.e., less than 15 million sperm per milliliter). Receives: Device: Standard sperm preparation; Device: HyperSperm | |
| Cryopreserved semen | Semen samples that have been preserved through freezing and stored at ultra-low temperatures. Receives: Device: Standard sperm preparation; Device: HyperSperm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperactivation
Percentage of sperm cells displaying hyperactivated motility
Measured: 2 hours
Secondary outcomes (4)
Sperm vitality
Percentage of viable sperm cells
Measured: 2 hours
DNA fragmentation
Percentage of TUNEL-positive sperm cells
Measured: 2 hours
Sperm motility
Percentage of motile sperm cells
Measured: 2 hours
Survival
Percentage of motile sperm cells after overnight incubation
Measured: 20 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start14 Jan 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Reproductive IssuesStudies 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
- 300 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
- NCT06742437
- Sponsor's protocol ID
- HyperSperm01
- Acronym
- HyperSperm01
- Status last verified
- Feb 2026
- First submitted
- 12 Dec 2024
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Martinez-Vallejo MJ, Carrasquel-Martinez G, Artigues RN, Lattes K, Varea RL, Mas MR, Guirado SR, Ibanez E, Gomez-Elias MD, Buffone MG. Efficacy and safety evaluation of HyperSperm treatment in human semen samples. J Transl Med. 2026 Jan 22;24(1):253. doi: 10.1186/s12967-025-07656-z.
PubMed 41572335
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a New Sperm Capacitation Method: a Prospective in Vitro Study on Semen Samples
- ClinicalTrials.gov ID
- NCT06742437
- Acronym / sponsor ID
- HyperSperm01 / HyperSperm01
- Conditions
- Reproductive Issues, Male Infertility, Asthenozoospermia, Oligozoospermia, Teratozoospermia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fecundis Lab SLUniversity, hospital or other
- Study start
- 14 Jan 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 19 Dec 2024 (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 evaluate the efficacy and safety of HyperSperm, a new sperm capacitation method, in 300 semen samples with various characteristics and abnormalities, in an in vitro study over 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Normozoospermic | – | Device: Standard sperm preparation, Device: HyperSpermSemen samples with normal sperm parameters as defined by the World Health Organization guidelines (e.g., normal sperm concentration, motility, and morphology). |
| Teratozoospermic | – | Device: Standard sperm preparation, Device: HyperSpermSemen samples with abnormal sperm morphology, where the percentage of morphologically normal sperm is below the threshold set by the World Health Organization (i.e., 4%). |
| Asthenozoospermic | – | Device: Standard sperm preparation, Device: HyperSpermSemen samples characterized by reduced sperm motility, where the percentage of progressive motile sperm is below the threshold set by the World Health Organization (i.e., 32%). |
| Oligozoospermic | – | Device: Standard sperm preparation, Device: HyperSpermSemen samples with a low sperm concentration, below the World Health Organization reference value (i.e., less than 15 million sperm per milliliter). |
| Cryopreserved semen | – | Device: Standard sperm preparation, Device: HyperSpermSemen samples that have been preserved through freezing and stored at ultra-low temperatures. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Men attending fertility clinics who provide a semen sample with normal parameters (normozoospermia), or present a male factor (asthenozoospermia, oligozoospermia, teratozoospermia, or a combination thereof).
Key inclusion criteria (1 listed)
- Ability to provide a semen sample via masturbation
Key exclusion criteria (4 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
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 |
|---|---|---|
| Standard sperm preparationSperm samples in the control group will undergo traditional processing | Device | Asthenozoospermic, Cryopreserved semen, Normozoospermic, Oligozoospermic, Teratozoospermic |
| HyperSpermSperm samples in the experimental group will undergo product-specific processing | Device | Asthenozoospermic, Cryopreserved semen, Normozoospermic, Oligozoospermic, Teratozoospermic |
Primary outcome
Hyperactivation
Time frame: 2 hours
Percentage of sperm cells displaying hyperactivated motility
4 secondary outcomes
Sperm vitality
Time frame: 2 hours
DNA fragmentation
Time frame: 2 hours
Sperm motility
Time frame: 2 hours
Survival
Time frame: 20 hours
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 1 Sep 2026.
- Derived from this study: PubMed 41572335Martinez-Vallejo MJ, Carrasquel-Martinez G, Artigues RN, Lattes K, Varea RL, Mas MR, Guirado SR, Ibanez E, Gomez-Elias MD, Buffone MG. Efficacy and safety evaluation of HyperSperm treatment in human semen samples. J Transl Med. 2026 Jan 22;24(1):253. doi: 10.1186/s12967-025-07656-z.
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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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reproductive Issues and Male Infertility, run by Fecundis Lab SL at 4 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 1 inclusion and 4 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 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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?
Hyperactivation (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06742437, which also lists 1 linked publication.
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 1 Sep 2026.