Study of Fertibiome4 Probiotic Effects on Vaginal Microbiota in Couples and Women with Fertility Disorders Undergoing IVF Treatment

What this Trial Is About

Researchers are studying the effects of a probiotic supplement called Fertibiome Ligilactobacillus salivarius PS11610 on the vaginal microbiota of couples or women experiencing fertility disorders. The study aims to confirm whether this probiotic can improve vaginal health, which is linked to better pregnancy outcomes. This randomized, double-blind, placebo-controlled trial involves participants undergoing or planning to start in vitro fertilization IVF treatment. The study is sponsored by ProbiSearch SL and will last about six months, including a six-month treatment period and continuation until 12 weeks of pregnancy if conception occurs during the study. Participants will be randomly assigned to one of two groups one receiving the probiotic and the other receiving a placebo. Women in the probiotic group will take two capsules daily one every 12 hours for six months, and men in the same group will take one capsule daily. If a woman becomes pregnant during the study, she will take one capsule daily during the first 12 weeks of pregnancy. The placebo group will follow the same schedule but receive placebo capsules. During the study, participants will be closely monitored through various assessments, including vaginal microbiota analysis to measure dysbiosis and Lactobacillus levels at baseline, three months, and six months. Pregnancy rates, miscarriage rates, and reproductive treatment outcomes will also be tracked. Blood samples will be taken to measure inflammatory markers before and after treatment. The primary outcome is the percentage of women with vaginal dysbiosis after three and six months of treatment. The total participation time is approximately six months, with additional monitoring if pregnancy occurs.

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