Modulating the Vaginal Microbiome After Implantation Failure

Zealand University Hospital

Status and phase: Completed; Phase 4

Conditions: Implantation Failure; Vaginal Flora Imbalance; Infertility, Female

Treatments: Drug: Vivag Plus; Drug: Placebo - Cap

Study type: Interventional

Funder types: Other

Identifiers

NCT03843112

REG-076-2018

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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74 participants in 2 patient groups, including a placebo group

Vivag Plus

Active Comparator group

Description:

Vivag Plus vaginal supplements one capsule every night for ten days start cycle day 6-7.

Treatment:

Drug: Vivag Plus

Placebo

Placebo Comparator group

Description:

Placebo vaginal supplements one capsule every night for ten days start cycle day 6-7.

Treatment:

Drug: Placebo - Cap