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.
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.
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.
Azoospermia
Sperm motility (A + B) < 25%.
Parallel
Probiotic
Dietary supplement* Women: 1 capsule of probiotic (Ligilactobacillus salivarius PS11610) every 12 hours for 6-months. In case of pregnancy: * Women: 1 capsule of probiotic per day for 12 weeks. * Men: 1 capsule of probiotic (Ligilactobacillus salivarius PS11610) per day for 6-months.
Placebo
Dietary supplement* Women: 1 capsule of placebo every 12 hours for 6-months. In case of pregnancy: * Women:1 capsule of placebo per day for 12 weeks. * Men: 1 capsule of placebo per day for 6-months.
Percentage (%) of women with vaginal dysbiosis after 3 months of treatment.
The percentage of vaginal dysbiosis confirmed will be compared between groups of treatment.
Percentage (%) of women with vaginal dysbiosis after 6 months of treatment.
The percentage of vaginal dysbiosis confirmed will be compared between groups of treatment.
Number of vaginal dysbiosis criteria in case of pregnancy confirmation.
Percentage (%) of women with vaginal dysbiosis.
Number of dysbiosis criteria per woman.
Number of dysbiosis criteria per woman.
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