Modulating the Vaginal Microbiome After Implantation Failure

Zealand University Hospital74 enrolled

Overview

Vaginal microbiome has in studies shown a link with the outcome of fertility treatment. The investigators wish to determine if it is possible to change an unfavorable vaginal microbiome using lactobacilli loaded vaginal supplements.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Implantation Failure Infertility, Female Vaginal Flora Imbalance

Interventions

Vivag PlusDRUG

Contains two lactobacilli strains; l. gasseri and l. rhamnosus

Placebo - CapDRUG

Vaginal supplements

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 43 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * unfavorable vaginal microbiome using ARTPreds test * non-smoker Exclusion Criteria: * use of oral antibiotics oral probiotics between diagnosis and inclusion in the study * pregnancy at inclusion * allergy towards study drugs

Locations (1)

Fertilitetsklinikken, Region Sjælland

Køge, Denmark

Outcomes

Primary Outcomes

Change in vaginal microbiome after intervention

The investigators wish to determine if the vaginal microbiome will stay changed one month after intervention. The change in vaginal microbiome will be measured with ARTPreds diagnostic test, after intervention and again one month later. The test divides the vaginal microbiome into three categories, low, medium and high. A change in vaginal microbiome is defined by a shift from low to medium or high, or a shift from medium to high.

Time frame: 2 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.