Modulating the Vaginal Microbiome After Implantation Failure

NCT03843112 | Completed Phase 4 DMC

• 1 other identifier: REG-076-2018
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Implantation Failure; Infertility, Female; Vaginal Flora Imbalance

Keywords

Infertility, female; Vaginal microbiome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Vivag Plus

ACTIVE COMPARATOR

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

Drug: Vivag Plus

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo - Cap

Interventions

Vivag Plus DRUG

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

Vivag Plus

Placebo - Cap DRUG

Vaginal supplements

Also known as: Placebo vaginal capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• unfavorable vaginal microbiome using ARTPreds test
• non-smoker

You may not qualify if:

• allergy towards study drugs

Sponsors & Collaborators

• Zealand University Hospital: lead
• ARTPred: collaborator
• Bifodan A/S: collaborator

Study Sites (1)

Fertilitetsklinikken, Region Sjælland

Køge, 4600, Denmark

Location

Related Publications (1)

• Jepsen IE, Saxtorph MH, Englund ALM, Petersen KB, Wissing MLM, Hviid TVF, Macklon N. Probiotic treatment with specific lactobacilli does not improve an unfavorable vaginal microbiota prior to fertility treatment-A randomized, double-blinded, placebo-controlled trial. Front Endocrinol (Lausanne). 2022 Dec 1;13:1057022. doi: 10.3389/fendo.2022.1057022. eCollection 2022.

  PMID: 36531460 DERIVED

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, investigator, care providers and outcome assessors are all blinded until the end of inclusion af the last subject.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomised placebo controlled, double blinded study

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: February 15, 2019
• Study Start: March 1, 2019
• Primary Completion: January 5, 2021
• Study Completion: February 27, 2021
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)