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

ProbiSearch SL120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

120

Conditions

Fertility Disorders

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Percentage (%) of women with vaginal dysbiosis after 3 months of treatment.

The percentage of vaginal dysbiosis confirmed will be compared between groups of treatment.

Time frame: After 3 months of intervention.

Percentage (%) of women with vaginal dysbiosis after 6 months of treatment.

The percentage of vaginal dysbiosis confirmed will be compared between groups of treatment.

Time frame: After 6 months of intervention.

Secondary Outcomes

Number of vaginal dysbiosis criteria in case of pregnancy confirmation.

Time frame: Up to 6 months.

Percentage (%) of women with vaginal dysbiosis.

Time frame: Before intervention.

Number of dysbiosis criteria per woman.

Time frame: Before intervention.

Number of dysbiosis criteria per woman.

Time frame: After 3 months of treatment pregnancy confirmation.

Number of dysbiosis criteria per woman.

Time frame: After 6 months of treatment or pregnancy confirmation.

Percentage of Lactobacillus in vaginal microbiota.

Time frame: Before intervention.

Percentage of Lactobacillus in vaginal microbiota.

Time frame: After 3 months of treatment or pregnancy confirmation.

Percentage of Lactobacillus in vaginal microbiota.

Time frame: After 6 months of treatment or pregnancy confirmation.

Number of reproductive treatments during the study period.

Time frame: After 6 months of treatment or pregnancy confirmation.

Pregnancy rate.

Time frame: After 6 months of treatment or pregnancy confirmation.

Time elapsed from the beginning of the study, until the occurrence of pregnancy.

Time frame: Up to 6 months.

Spontaneous pregnancy rate, not associated to fertility treatment (IVF or AI).

Time frame: Up to 6 months.

Miscarriage rate in the first trimester of pregnancy.

Time frame: Before 12 weeks of pregnancy.

Number of oocytes extracted.

Time frame: Before IVF cycle.

Embryo Quality (A, B or C).

Time frame: Before IVF cycle.

Number of vaginal dysbiosis criteria at the time of embryo transfer per IVF cycle.

Time frame: Before IVF cycle.

Levels (pg/ml) of pro-inflammatory and anti-inflammatory markers in blood plasma of women.

Time frame: Before intervention.

Levels (pg/ml) of pro-inflammatory and anti-inflammatory markers in blood plasma of women.

Time frame: After 6 months of treatment or pregnancy confirmation.

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts