Modulating the Vaginal Microbiome After Implantation Failure

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03843112
• Other study ID #: REG-076-2018
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2019
• Est. completion date: February 27, 2021

Study information

• Verified date: March 2021
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: February 27, 2021
• Est. primary completion date: January 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Implantation Failure
• Infertility
• Infertility, Female
• Vaginal Flora Imbalance

Intervention

Drug:
• Vivag Plus
Contains two lactobacilli strains; l. gasseri and l. rhamnosus
• Placebo - Cap
Vaginal supplements

Locations

Country	Name	City	State
Denmark	Fertilitetsklinikken, Region Sjælland	Køge

Sponsors (3)

Lead Sponsor	Collaborator
Zealand University Hospital	ARTPred, Bifodan A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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