Modulating the vaginal microbiome after experiencing failure in IVF after multiple embryo transfers
Phase 1
- Conditions
- Sub-optimal vaginal and/or endometrial microbiome.MedDRA version: 20.0Level: LLTClassification code 10046960Term: Vaginosis bacterialSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2018-002376-41-DK
- Lead Sponsor
- Zealand University Hospital, Gynecological department
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 74
Inclusion Criteria
Sub-optimal microbiome diagnosed
Age < 43 years
non-smoker
Included in RIF-project and agreed to be contacted in case of other research study
Diagnosed with a sub-optimal microbiome following testing in our fertility clinic
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 74
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Age < 18 years
Use of antibiotics and/or porbiotics between diagnose and inclusion
Pregnant at enrollment
Allergy towards the study drug
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable