Modulating the Vaginal Microbiome After Implantation Failure

Modulating the Vaginal Microbiome After Implantation Failure A Randomized Placebo Controlled Study of Vaginal Lactobacilli Supplements

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 Overview

• Status: Completed
• Conditions: Infertility, Female; Vaginal Flora Imbalance; Implantation Failure
• Intervention / Treatment: Drug: Vivag Plus; Drug: Placebo - Cap

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Køge, Denmark, 4600
    • Fertilitetsklinikken, Region Sjælland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vivag Plus; Vivag Plus vaginal supplements one capsule every night for ten days start cycle day 6-7.	Drug: Vivag Plus; Contains two lactobacilli strains; l. gasseri and l. rhamnosus
Placebo Comparator: Placebo; Placebo vaginal supplements one capsule every night for ten days start cycle day 6-7.	Drug: Placebo - Cap; Vaginal supplements; Other Names: Placebo vaginal capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 months

Collaborators and Investigators

• Sponsor: Zealand University Hospital
• Collaborators: ARTPred; Bifodan A/S

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): January 5, 2021
• Study Completion (Actual): February 27, 2021

Study Registration Dates

• First Submitted: February 8, 2019
• First Submitted That Met QC Criteria: February 12, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 22, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Infertility, female; Vaginal microbiome
• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID Numbers: REG-076-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No