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Completed

NCT Number: NCT03843112

Modulating the Vaginal Microbiome After Implantation Failure

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.

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Key information

Conditions

Implantation Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Infertility, Female Urogenital Diseases Vaginal Flora Imbalance

Age range

18 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Fertilitetsklinikken, Region Sjælland

Køge, 4600, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vivag Plus

Drug

Contains two lactobacilli strains; l. gasseri and l. rhamnosus

Placebo - Cap

Drug

Vaginal supplements

Other names: Placebo vaginal capsule

Primary outcomes

  1. Change in vaginal microbiome after intervention

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Collaborators

  • ARTPred
  • Bifodan A/S

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 15, 2019
Registry last updated
Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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