Actively Recruiting
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.
Led by ProbiSearch SL · Updated on 2026-04-13
120
Participants Needed
2
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Effect of a Probiotic on the Female Genital Tract Microbiota of Participants With Fertility Disorders.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Couples or women aged 18 to 45 (women) and 18 to 55 (men in couples).
- Diagnosed with fertility disorders.
- Undergoing or willing to start IVF treatment.
- Signed informed consent form.
You will not qualify if you...
- Women not in a couple who have not had at least 4 cycles of artificial insemination with donor sperm or 1 IVF cycle without pregnancy.
- Women with body mass index (BMI) of 30 or higher.
- Couples where the woman is not diagnosed with infertility, but the man has azoospermia, low sperm motility (<25%), poor sperm morphology (≤2%), or vas deferens obstruction.
- Presence of chronic diseases causing intestinal malabsorption.
- Congenital or acquired immunodeficiency.
- Current or past history of alcohol, tobacco, or drug abuse.
- Uncertainty about ability or willingness to comply with the study protocol.
- Use of probiotics in the last week before the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months or 12 weeks after pregnancy confirmation
Participants take probiotic or placebo capsules daily for up to 6 months. Women who become pregnant will continue taking 1 capsule daily for the first 12 weeks of pregnancy.
Regular visits during treatment period
Trial Site Locations
Total: 2 locations
1
Dr. Miguel Raimundo (Portugal)
Lisbon, Portugal
Actively Recruiting
2
Hospital Universitario La Paz
Madrid, Madrid, Spain, 28046
Actively Recruiting
Research Team
S
Susana Manzano Jiménez, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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