Modulating the Vaginal Microbiome After Implantation Failure

Phase 4

Completed

• Conditions: Vaginal Flora Imbalance; Implantation Failure; Infertility, Female
• Interventions: Drug: Vivag Plus; Drug: Placebo - Cap

• Registration Number: NCT03843112
• Lead Sponsor: Zealand University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-08
• Study First Submitted QC: 2019-02-12
• Study First Posted: 2019-02-15
• Study Start: 2019-03-01
• Primary Completion: 2021-01-05
• Study Completion: 2021-02-27
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-22
• Last Update Posted: 2021-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vivag Plus	Vivag Plus	Vivag Plus vaginal supplements one capsule every night for ten days start cycle day 6-7.
Placebo	Placebo - Cap	Placebo vaginal supplements one capsule every night for ten days start cycle day 6-7.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Fertilitetsklinikken, Region Sjælland; 🇩🇰 Køge, Denmark