Status
Conditions
Treatments
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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:
Couples or women with any of the following characteristics:
Primary purpose
Allocation
Interventional model
Masking
120 participants in 2 patient groups, including a placebo group
Loading...
Central trial contact
Susana Manzano Jiménez, PhD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal