Health TrialsbyHealthPanel

Efficacy and Safety of a New Sperm Capacitation Method

ConditionsReproductive IssuesMale InfertilityAsthenozoospermiaOligozoospermiaTeratozoospermia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-60
SponsorFecundis Lab SL

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Ability to provide a semen sample via masturbation

Disqualifiers

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 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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Standard sperm preparation

    Device

    Sperm samples in the control group will undergo traditional processing

  • HyperSperm

    Device

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

Treatment groups

300 Participants
are divided into 5 treatment groups
Group A: Normozoospermic2 interventions
Group B: Teratozoospermic2 interventions
Group C: Asthenozoospermic2 interventions
Group D: Oligozoospermic2 interventions
Group E: Cryopreserved semen2 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fecundis Lab SL

Lead sponsor

Source ClinicalTrials.gov
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