Modulating the vaginal microbiome after experiencing failure in IVF after multiple embryo transfers

Modulating the Vaginal Microbiome after Implantation Failure - A randomized placebo controlled study of lactobacilli supplements

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002376-41-DK

Enrollment

Registered

2018-08-17

Start date

2018-09-10

Completion date

Unknown

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sub-optimal vaginal and/or endometrial microbiome. MedDRA version: 20.0 Level: LLT Classification code 10046960 Term: Vaginosis bacterial System Organ Class: 100000004862

Interventions

Trade Name: Vivag Plus Product Name: Vivag Plus Pharmaceutical Form: Vaginal tablet INN or Proposed INN: Lactobacillus rhamnosus CAS Number: L04001-00-0 Other descriptive name: LACTOBACILLUS RHAMNOSUS

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Sub-optimal microbiome diagnosed Age =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Age < 18 years Use of antibiotics and/or porbiotics between diagnose and inclusion Pregnant at enrollment Allergy towards the study drug

Design outcomes

Primary

Measure	Time frame
Main Objective: Investigate change of microbiome in population after treatment with Vivag Plus or placebo over the course of two months.;Secondary Objective: Not applicable;Primary end point(s): Demonstrate difference in change of microbiome between treatment and placebo group and that the change in microbiome are stabile over the course of one month.;Timepoint(s) of evaluation of this end point: First evaluation to be made when the inclusion is final.	—

Measure

Time frame

Main Objective: Investigate change of microbiome in population after treatment with Vivag Plus or placebo over the course of two months.;Secondary Objective: Not applicable;Primary end point(s): Demonstrate difference in change of microbiome between treatment and placebo group and that the change in microbiome are stabile over the course of one month.;Timepoint(s) of evaluation of this end point: First evaluation to be made when the inclusion is final.

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Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Denmark

Contacts

Public ContactFertilitetsklinikken

University Hospital Zealand

004559484270

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026