Efficacy and Safety of a New Sperm Capacitation Method (HyperSperm01)

February 24, 2026 updated by: Fecundis Lab SL

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Barcelona
      • Barcelona, Barcelona, Spain, 08006
        • Recruiting
        • Eugin Barcelona
        • Contact:
      • Barcelona, Barcelona, Spain, 08010
      • Barcelona, Barcelona, Spain, 08017
        • Recruiting
        • CIRH
        • Contact:
      • Barcelona, Barcelona, Spain, 08029
        • Recruiting
        • Natuvitro
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

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).

Description

Inclusion Criteria:

  • Ability to provide a semen sample via masturbation

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Sperm samples in the control group will undergo traditional processing
Device: HyperSperm
Sperm samples in the experimental group will undergo product-specific processing
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
Sperm samples in the control group will undergo traditional processing
Device: HyperSperm
Sperm samples in the experimental group will undergo product-specific processing
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
Sperm samples in the control group will undergo traditional processing
Device: HyperSperm
Sperm samples in the experimental group will undergo product-specific processing
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
Sperm samples in the control group will undergo traditional processing
Device: HyperSperm
Sperm samples in the experimental group will undergo product-specific processing
Cryopreserved semen
Semen samples that have been preserved through freezing and stored at ultra-low temperatures.
Device: Standard sperm preparation
Sperm samples in the control group will undergo traditional processing
Device: HyperSperm
Sperm samples in the experimental group will undergo product-specific processing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hyperactivation
Time Frame: 2 hours
Percentage of sperm cells displaying hyperactivated motility
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sperm vitality
Time Frame: 2 hours
Percentage of viable sperm cells
2 hours
DNA fragmentation
Time Frame: 2 hours
Percentage of TUNEL-positive sperm cells
2 hours
Sperm motility
Time Frame: 2 hours
Percentage of motile sperm cells
2 hours
Survival
Time Frame: 20 hours
Percentage of motile sperm cells after overnight incubation
20 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fecundis Lab SL

Investigators

  • Principal Investigator: Mariona Rius Mas, PhD, Fertty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

December 12, 2024

First Submitted That Met QC Criteria

December 16, 2024

First Posted (Actual)

December 19, 2024

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HyperSperm01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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