Effect of a Probiotic on the Female Genital Tract Microbiota of Participants With Fertility Disorders.

A Randomized, Double-blind, Placebo-controlled Study to Confirm the Positive Effect of Fertibiome® (Ligilactobacillus Salivarius PS11610) on the Female Genital Tract Microbiota of Couples or Women With Fertility Disorders.

In the last decades, numerous publications have broken the old paradigm that considered the urogenital tracts as sterile, demonstrating that microorganisms present in the urogenital tract represent the 9% of the whole human microbiome. Healthy urogenital microbiome improves implantation rate and pregnancy outcomes, whereas 40% of dysbiosis prevalence is observed in women under assisted reproductive treatment (ART).

Infertility causes are associated with male, female, or combined failure. It has been shown that oral probiotic treatment, mainly with Lactobacillus, recovers a healthy vaginal microbiota without safety concerns.

An interventional, randomized, double-blind, placebo-controlled study will be conducted to confirm the positive effect of the commercial probiotic product Fertibiome® on the vaginal dysbiosis of couples or women with fertility disorders.

The duration of the study will be of 6 months approximately, including 6 months of product intake. In case of pregnancy during intervention, women will continue their participation until week 12 of gestation.

Participants will be randomly assigned to one of the two study groups: control group with placebo administration or probiotic administration group. Women will take 1 capsule every 12 hours and men 1 per day. In case of women participating alone they will take 1 capsule every 12 hours. In case of pregnancy, only women will continue taking 1 capsule per day for the first 12 weeks.

Inclusion Criteria:

• Couples or women with ages between 18 and 45 for woman and between 18 and 55 for man (in case of couple participation).
• Couples or women with fertility disorders.
• Couples or women undergoing IVF treatment or willing to start it.
• Signature of the Informed Consent.

Exclusion Criteria:

• Women, not participating in the study with a couple, who have not undergone at least 4 cycles of artificial insemination with donor's sperm (AID) or 1 cycle of IVF without achieving evolutionary pregnancy.

• Women with Body Mass Index (BMI) ≥ 30.

• Couples where the woman has not infertility diagnosis while the man has any of the following characteristics:

  • Azoospermia
  • Sperm motility (A + B) < 25%.
  • Sperm morphology ≤ 2%.
  • Vas deferens obstruction.

• Couples or women with any of the following characteristics:

  • Chronic diseases that cause intestinal malabsortion.
  • Congenital or acquired immunodeficiency.
  • Current history or diagnosis of alcohol, tobacco, or drug abuse.
  • Uncertainty about the willingness or ability of participants to comply with the requirements of the protocol.
  • Under treatment with probiotics during the last week.