Probiotic treatment to improve sperm quality and reproductive outcomes in infertile men
Effect of Antioxidant Probiotic Administration on Seminal Quality and Reproductive Outcomes.
This study is testing whether a combination of two probiotics can improve sperm quality and help men struggling with infertility.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Male |
| Sponsor | Fundación IVI Academic / other |
| Locations | 1 site (Valencia) |
| Trial ID | NCT04585984 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of a combination of two probiotics on the quality of semen and reproductive outcomes in infertile men. It is a prospective randomized intervention conducted at the IVIRMA Valencia clinic, where eligible participants will be assigned to either a treatment group receiving probiotics or a control group receiving a placebo. The study aims to address the growing issue of male factor infertility, which accounts for a significant portion of infertility cases. Data will be collected over two years to assess the effectiveness of the probiotic intervention on sperm parameters and subsequent reproductive success.
Who should consider this trial
Good fit: Ideal candidates include men aged 18-45 with a minimum of 5 million progressive mobile spermatozoa and women aged 18-37 using their own oocytes or older women using donated oocytes from younger donors.
Not a fit: Patients with a female BMI over 30, severe reproductive issues, or those who have used certain medications or probiotics recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance sperm quality and improve fertility outcomes for men facing infertility issues.
How similar studies have performed: While the use of probiotics in fertility treatments is an emerging area, similar studies have shown promising results in improving reproductive outcomes, though this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men aged 18-45 years old * Men with more than 5 million progressive mobile spermatozoa in the ejaculate * Women aged 18-37 using their own oocytes * Women aged \>37 using donated oocytes where the donor is \<36 years of age. * Women with AMH values between 1-5 ng/ml or 5-35 pmol/l Exclusion Criteria: * Female BMI \>30kg/m\^2 * Known female history of thrombophilia * Known history of endometriosis stages III-IV * Known history of severe adenomyosis * Repeated implantation failures * Recurrent miscarriages, Mullerian abnormalities or hydrosalpinx * Use of any other probiotics by the male partner within the previous 3 months (to take account of a full spermatogenic cycle) * Use of antibiotics by the male partner within the previous 3 months * Known use of corticosteroids * Known history of sexually transmitted diseases
Where this trial is running
Valencia
- IVIRMA Valencia — Valencia, Spain (Recruiting)
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.