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

NCT04585984 | Completed

• 1 other identifier: 1905-FIVI-063-NG
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Probiotic; Lactobacillus rhamnosus; Bifidobacterium longum; Sperm DNA fragmentation; Seminal microbiota

Outcome Measures

Primary Outcomes (1)

• Live birth rate per cycle

  Percentage of cases in which a complete treatment of assisted reproduction is carried out with control or experimental semen, which manage to obtain offspring for each cycle of ovarian stimulation included in the study.

  through study completion, an average of 1 year

Study Arms (2)

Control

PLACEBO COMPARATOR

140 men will be taking a placebo once a day during 21 days prior to the start of the IVF/ICSI cycle.

Dietary Supplement: Placebo

Experimental

EXPERIMENTAL

140 men will be taking the probiotic compound (50% of each probiotic: Lactobacillus rhamnosus and Bifidobacterium longum at a dose of 10\^9 cfu/day) once a day for 21 days prior to the start of the IVF/ICSI cycle.

Dietary Supplement: Experimental - Probiotic

Interventions

Experimental - Probiotic DIETARY_SUPPLEMENT

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.

Also known as: Lactobacillus rhamnosus, Bifidobacterium longum

Experimental

Placebo DIETARY_SUPPLEMENT

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

Also known as: Control

Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Semen analysis and seminal microbiota analysis.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación IVI: lead
• ADM Protexin: collaborator
• Biopolis S.L.: collaborator
• Instituto Valenciano de Infertilidad, IVI VALENCIA: collaborator

Study Sites (1)

IVIRMA Valencia

Valencia, Valencia, 46015, Spain

Location

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patient, investigator, assessing physician, embryologist and all site personnel with the exception of the trial nurse/coordinator and/or pharmacy assistant will remain blinded throughout the course of the trial as to which treatment each subject received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 14, 2020
• Study Start: February 5, 2021
• Primary Completion: November 14, 2024
• Study Completion: November 14, 2024
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)