Modulating the Vaginal Microbiome After Implantation Failure
NCT ID: NCT03843112
Last Updated: 2021-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
74 participants
INTERVENTIONAL
2019-03-01
2021-02-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Transplantation of Vaginal Mikrobiome
NCT04855006
Performance and Safety of Lactal Gel for Treatment of Bacterial Vaginosis
NCT07241871
Safety and Efficacy of Vaginal Microbiota Transplant (VMT) in Women With Bacterial Vaginosis (BV)
NCT03769688
Effects of a Vaginal Contraceptive Ring on Vaginal Microbiota and Local Immunity
NCT02432404
Exploring the Effects of an Intravaginal Lactic Acid Gel on the Vaginal Microbiome
NCT05753813
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Vivag Plus
Vivag Plus vaginal supplements one capsule every night for ten days start cycle day 6-7.
Vivag Plus
Contains two lactobacilli strains; l. gasseri and l. rhamnosus
Placebo
Placebo vaginal supplements one capsule every night for ten days start cycle day 6-7.
Placebo - Cap
Vaginal supplements
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vivag Plus
Contains two lactobacilli strains; l. gasseri and l. rhamnosus
Placebo - Cap
Vaginal supplements
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* non-smoker
Exclusion Criteria
* pregnancy at inclusion
* allergy towards study drugs
18 Years
43 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ARTPred
UNKNOWN
Bifodan A/S
UNKNOWN
Zealand University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nicholas Macklon
Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fertilitetsklinikken, Region Sjælland
Køge, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
REG-076-2018
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.