Modulating the Vaginal Microbiome After Implantation Failure A Randomized Placebo Controlled Study of Vaginal Lactobacilli Supplements
Overview
- Phase
- Phase 4
- Intervention
- Vivag Plus
- Conditions
- Implantation Failure
- Sponsor
- Zealand University Hospital
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Change in vaginal microbiome after intervention
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Nicholas Macklon
Professor
Zealand University Hospital
Eligibility Criteria
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
Arms & Interventions
Vivag Plus
Vivag Plus vaginal supplements one capsule every night for ten days start cycle day 6-7.
Intervention: Vivag Plus
Placebo
Placebo vaginal supplements one capsule every night for ten days start cycle day 6-7.
Intervention: Placebo - Cap
Outcomes
Primary Outcomes
Change in vaginal microbiome after intervention
Time Frame: 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.