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Search / Trial NCT04585984

Effect of Antioxidant Probiotic Administration on Seminal Quality and Reproductive Outcomes.

Launched by FUNDACIÓN IVI · Oct 13, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Probiotic Lactobacillus Rhamnosus Bifidobacterium Longum Sperm Dna Fragmentation Seminal Microbiota

ClinConnect Summary

This clinical trial is investigating how a specific type of probiotic, which are good bacteria that can help improve health, affects semen quality and fertility in men who are experiencing infertility. The study specifically looks at two strains of probiotics and aims to see if taking them can enhance important factors like sperm concentration, movement, and overall quality. The goal is to determine if these improvements in sperm can lead to better outcomes during assisted reproduction treatments, like in vitro fertilization (IVF).

To be eligible for this study, participants need to be men aged 18 to 45 with a certain level of active sperm in their semen. Women participating in the IVF treatments must also meet specific age and health criteria. If men decide to join the study, they will take the probiotics and undergo regular assessments to check their sperm health and overall reproductive results. It's important to note that certain health conditions or recent medical treatments may prevent participants from joining the trial. This study could potentially open new avenues for helping couples facing fertility challenges.

Gender

MALE

Eligibility 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

About Fundación Ivi

Fundación IVI is a leading clinical research organization dedicated to advancing reproductive health and fertility treatments through innovative research and development. With a focus on enhancing patient outcomes, the foundation conducts rigorous clinical trials aimed at improving assisted reproductive technologies and expanding access to cutting-edge therapies. Committed to ethical practices and scientific excellence, Fundación IVI collaborates with healthcare professionals and institutions globally to foster advancements in reproductive medicine, ensuring that the latest findings translate into effective patient care.

Locations

Valencia, , Spain

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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