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

Summary

The quality of semen plays a fundamental role in correct fertilization and development of normal embryos that result in a live birth. Unfortunately, semen quality has declined during the last decades, and reduced more and more. The cases of male factor infertility currently correspond to 30% of the reported cases of infertility. The parameters that are directly affected in infertile men reflecting an impaired spermatogenesis are sperm concentration, motility, morphology, ejaculate volume and DNA damage, in addition to various alterations at the molecular level that often go unnoticed and are related to the physiological capacity of the sperm. These alterations result in a decrease in reproductive capacity, which leads to the need for assisted reproduction techniques (ART). The identification of new ways to increase the quality of sperm could be very useful to improve the reproductive performance of patients.

Probiotics are defined as 'living microorganisms, which, when administered in adequate amounts, confer benefits for the health of the host'. The consumption of probiotics is increasing worldwide as therapy for many different diseases and disorders. In the field of assisted reproduction, the microbiome has been extensively studied with respect to the female endometrium to assess endometrial receptivity. However, there is little evidence about the role of the microbiome in semen. Previous studies demonstrated a moderate improvement on some sperm parameters, but still there is a need to confirm its translation into a clinical contribution to reproductive success.

The aim of this study is to evaluate the effect of these strains, Lactobacillus rhamnosus CECT8361 and Bifidobacterium longum CECT7347, on the seminal quality of infertile patients coming to IVIRMA clinics to undergo their first IVF/ICSI cycle by means of determining direct improvement on the basic sperm analysis results, on sperm DNA integrity and on the seminal microbiome profile, to ultimately evaluate the effect that it may have on the embryo quality and reproductive results of the cycles of these patients.

Conditions

• Male Infertility

Interventions

DIETARY_SUPPLEMENT

Experimental - Probiotic

Patients in the experimental group will take one compound (pill) a day for 21 days, containing a 50% combination of two probiotics: Lactobacillus rhamnosus and Bifidobacterium longum, at a dose of 10\^9 cfu/day. The carrier of lyophilized probiotics is maltodextrin and the mixture is encapsulated in hypromellose capsules.

DIETARY_SUPPLEMENT

Placebo

Patients in the control group will take one unit of placebo a day for 21 days.

Sponsors & Collaborators

• ADM Protexin

  collaborator INDUSTRY

• Biopolis S.L.

  collaborator INDUSTRY

• Instituto Valenciano de Infertilidad, IVI VALENCIA

  collaborator OTHER

• Fundación IVI

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-02-05

Primary Completion

2024-11-14

Completion

2024-11-14

Countries

• Spain

Study Locations