Evaluating a new method for sperm capacitation
Efficacy and Safety of a New Sperm Capacitation Method: a Prospective in Vitro Study on Semen Samples
This study is testing a new method called HyperSperm to see if it can improve sperm quality for men who are having trouble with fertility.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Male |
| Sponsor | Fecundis Lab SL Academic / other |
| Locations | 4 sites (Barcelona, Barcelona and 3 other locations) |
| Trial ID | NCT06742437 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the efficacy and safety of a new sperm capacitation method called HyperSperm. It involves a prospective, multicenter design where 300 semen samples with various characteristics and abnormalities will be analyzed over a 12-month period. The study utilizes a split-sample approach, comparing standard sperm preparation with the new method without any intervention. The goal is to gather data on how well HyperSperm performs in improving sperm quality for men facing reproductive issues.
Who should consider this trial
Good fit: Ideal candidates for this study are men who can provide a semen sample and are experiencing male infertility or related sperm quality issues.
Not a fit: Patients currently diagnosed with sexually transmitted infections or those who have participated in a clinical trial involving an intervention within the last 3 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new method to enhance sperm quality, potentially improving fertility outcomes for men with reproductive issues.
How similar studies have performed: While this approach is innovative, it is unclear if similar studies have shown success, as this specific method has not been widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Barcelona, Barcelona and 3 other locations
- Eugin Barcelona — Barcelona, Barcelona, Spain (Recruiting)
- Fertty — Barcelona, Barcelona, Spain (Recruiting)
- Cirh — Barcelona, Barcelona, Spain (Recruiting)
- Natuvitro — Barcelona, Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Mariona Rius Mas, PhD — Fertty
- Study coordinator: Matias Gomez Elias, PhD
- Email: mgomezelias@fecundis.com
- Phone: +34624174355
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.