Back to resultsModulating the Vaginal Microbiome After Implantation Failure
Primary Purpose
Implantation Failure, Infertility, Female, Vaginal Flora Imbalance
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Vivag Plus
Placebo - Cap
Sponsored by
About this trial
This is an interventional treatment trial for Implantation Failure focused on measuring Infertility, female, Vaginal microbiome
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
Sites / Locations
- Fertilitetsklinikken, Region Sjælland
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Vivag Plus
Placebo
Arm Description
Vivag Plus vaginal supplements one capsule every night for ten days start cycle day 6-7.
Placebo vaginal supplements one capsule every night for ten days start cycle day 6-7.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03843112
First Posted
February 8, 2019
Last Updated
March 22, 2021
Sponsor
Zealand University Hospital
Collaborators
ARTPred, Bifodan A/S
1. Study Identification
Unique Protocol Identification Number
NCT03843112
Brief Title
Modulating the Vaginal Microbiome After Implantation Failure
Official Title
Modulating the Vaginal Microbiome After Implantation Failure A Randomized Placebo Controlled Study of Vaginal Lactobacilli Supplements
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
January 5, 2021 (Actual)
Study Completion Date
February 27, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zealand University Hospital
Collaborators
ARTPred, Bifodan A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Implantation Failure, Infertility, Female, Vaginal Flora Imbalance
Keywords
Infertility, female, Vaginal microbiome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomised placebo controlled, double blinded study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Participants, investigator, care providers and outcome assessors are all blinded until the end of inclusion af the last subject.
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vivag Plus
Arm Type
Active Comparator
Arm Description
Vivag Plus vaginal supplements one capsule every night for ten days start cycle day 6-7.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo vaginal supplements one capsule every night for ten days start cycle day 6-7.
Intervention Type
Drug
Intervention Name(s)
Vivag Plus
Intervention Description
Contains two lactobacilli strains; l. gasseri and l. rhamnosus
Intervention Type
Drug
Intervention Name(s)
Placebo - Cap
Other Intervention Name(s)
Placebo vaginal capsule
Intervention Description
Vaginal supplements
Primary Outcome Measure Information:
Title
Change in vaginal microbiome after intervention
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Fertilitetsklinikken, Region Sjælland
City
Køge
ZIP/Postal Code
4600
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Modulating the Vaginal Microbiome After Implantation Failure
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