Implantation Failure, Infertility, Female, Vaginal Flora Imbalance
Conditions
Keywords
Infertility, female, Vaginal microbiome
Brief summary
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.
Interventions
DRUGVivag Plus
Contains two lactobacilli strains; l. gasseri and l. rhamnosus
DRUGPlacebo - Cap
Vaginal supplements
Sponsors
ARTPred
Bifodan A/S
Zealand University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants, investigator, care providers and outcome assessors are all blinded until the end of inclusion af the last subject.
Intervention model description
Randomised placebo controlled, double blinded study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in vaginal microbiome after intervention | 2 months | 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. |
Countries
Denmark
Outcome results
None listed