ClinicalTrials.gg
RecruitingNCT06742437HyperSperm01Updated Sep 1, 2026

Efficacy and Safety of a New Sperm Capacitation Method

An observational study in Reproductive Issues, Male Infertility and Asthenozoospermia, sponsored by Fecundis Lab SL. Recruiting at 4 sites in Spain. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Fecundis Lab SL · Observational

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 60 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Reproductive Issues
  • Male Infertility
  • Asthenozoospermia
  • Oligozoospermia
  • Teratozoospermia
03

In context

Infertility, Male

282 studies on the registry are indexed under Infertility, Male; 65 are open to participants now.

This study's planned enrollment of 300 is above the median of 182 across 87 observational studies indexed under Infertility, Male.

Browse Infertility, Male studies →

Lead sponsor

Fecundis Lab SL is the lead sponsor of 3 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Ability to provide a semen sample via masturbation

Exclusion criteria

Exclusion Criteria:

  • Current diagnosis of a sexually transmitted infection (STI)
  • Previous diagnosis of hepatitis A, B, C, D, or
  • Prior participation in this study
  • Participation in a clinical trial involving an intervention within the last 3 months
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • Normozoospermic

    Semen samples with normal sperm parameters as defined by the World Health Organization guidelines (e.g., normal sperm concentration, motility, and morphology).

    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%).

    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%).

    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).

    Device: Standard sperm preparation · Device: HyperSperm

  • Cryopreserved semen

    Semen samples that have been preserved through freezing and stored at ultra-low temperatures.

    Device: Standard sperm preparation · Device: HyperSperm

Interventions

  • DeviceStandard sperm preparation

    Sperm samples in the control group will undergo traditional processing

  • DeviceHyperSperm

    Sperm samples in the experimental group will undergo product-specific processing

06

What researchers measure

Primary outcomes

  1. Hyperactivation

    Percentage of sperm cells displaying hyperactivated motility

    Time frame: 2 hours

Secondary outcomes

  1. Sperm vitality

    Percentage of viable sperm cells

    Time frame: 2 hours

  2. DNA fragmentation

    Percentage of TUNEL-positive sperm cells

    Time frame: 2 hours

  3. Sperm motility

    Percentage of motile sperm cells

    Time frame: 2 hours

  4. Survival

    Percentage of motile sperm cells after overnight incubation

    Time frame: 20 hours

07

Study locations

4 of 4 sites recruiting
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06742437
Lead sponsor
Fecundis Lab SL
Responsible party
Sponsor
First posted
Dec 19, 2024
Start date
Jan 14, 2025
Primary completion
Sep 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
Sep 1, 2026

Study contacts

Matias Gomez Elias, PhD
Contact
mgomezelias@fecundis.com
+34624174355
Mariona Rius Mas, PhD
principal investigator · Fertty

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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