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Efficacy and Safety of a New Sperm Capacitation Method: a Prospective in Vitro Study on Semen Samples
Led by Fecundis Lab SL · Updated on 2026-02-27
300
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of HyperSperm, a new sperm capacitation method, in a prospective, multicenter in vitro study using 300 semen samples with different characteristics and abnormalities. This observational study aims to compare HyperSperm processing with standard sperm preparation methods over a 12-month period to better understand how this new technique may affect sperm function. Semen samples are grouped based on their sperm characteristics, including normal sperm parameters, abnormal morphology, reduced motility, low concentration, and frozen-thawed samples. Samples processed with HyperSperm will be compared to those treated with traditional preparation techniques. No interventions will be performed on participants themselves since this is a study on semen samples. Participants will provide semen samples collected by masturbation for laboratory analysis. Researchers will assess outcomes such as sperm hyperactivation, vitality, DNA fragmentation, motility, and survival at specific time points up to 20 hours after processing. The study will monitor these measures to evaluate the new capacitation method’s impact on sperm quality and safety over the course of the study, which runs until June 2026.
CONDITIONS
Brief Title
Efficacy and Safety of a New Sperm Capacitation Method
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to provide a semen sample via masturbation
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 2 hours
Participants provide semen samples that undergo either standard sperm preparation or a new product-specific processing method called HyperSperm.
1 visit (in-person)
Duration - Up to 20 hours
After sperm processing, sperm vitality, DNA fragmentation, motility, hyperactivation, and survival are assessed over up to 20 hours.
Observations during the initial visit
Trial Site Locations
Total: 4 locations
1
Eugin Barcelona
Barcelona, Barcelona, Spain, 08006
Actively Recruiting
2
Fertty
Barcelona, Barcelona, Spain, 08010
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3
CIRH
Barcelona, Barcelona, Spain, 08017
Actively Recruiting
4
Natuvitro
Barcelona, Barcelona, Spain, 08029
Actively Recruiting
Research Team
M
Matias Gomez Elias, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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