Implantation FailurePhase 4NCT03843112
Modulating the Vaginal Microbiome After Implantation Failure
A Phase 4 study testing Vivag Plus in people with Implantation Failure and Infertility, Female, run by Zealand University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Implantation Failure, Infertility, Female, Vaginal Flora Imbalance
- What is being tested?
- Vivag Plus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2019to 27 Feb 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- unfavorable vaginal microbiome using ARTPreds test
- non-smoker
Who cannot join
- use of oral antibiotics oral probiotics between diagnosis and inclusion in the study
- pregnancy at inclusion
- allergy towards study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modulating the Vaginal Microbiome After Implantation Failure A Randomized Placebo Controlled Study of Vaginal Lactobacilli Supplements
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.
- Being tested
- Vivag Plus, Placebo - Cap
- Keywords
- Infertility, female, Vaginal microbiome
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivag PlusDrug
Contains two lactobacilli strains; l. gasseri and l. rhamnosus
Placebo - CapDrug
Also called Placebo vaginal capsule
Vaginal supplements
| Study group | Role | What they receive |
|---|---|---|
| Vivag Plus | Active comparator | Vivag Plus vaginal supplements one capsule every night for ten days start cycle day 6-7. Receives: Drug: Vivag Plus |
| Placebo | Placebo comparator | Placebo vaginal supplements one capsule every night for ten days start cycle day 6-7. Receives: Drug: Placebo - Cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Mar 2019
- Primary completion5 Jan 2021
- Study completion27 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Implantation FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised placebo controlled, double blinded study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ARTPred, Bifodan A/S
- Responsible party
- Principal investigator, Nicholas Macklon, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843112
- Sponsor's protocol ID
- REG-076-2018
- Status last verified
- Mar 2021
- First submitted
- 8 Feb 2019
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36531460
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating the Vaginal Microbiome After Implantation Failure A Randomized Placebo Controlled Study of Vaginal Lactobacilli Supplements
- ClinicalTrials.gov ID
- NCT03843112
- Acronym / sponsor ID
- REG-076-2018
- Keywords
- Infertility, female, Vaginal microbiome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- ARTPred, Bifodan A/S
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 5 Jan 2021 (actual)
- Study completion
- 27 Feb 2021 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised placebo controlled, double blinded study
| Arm | Type | Receives |
|---|---|---|
| Vivag Plus | Active comparator | Drug: Vivag PlusVivag Plus vaginal supplements one capsule every night for ten days start cycle day 6-7. |
| Placebo | Placebo comparator | Drug: Placebo - CapPlacebo vaginal supplements one capsule every night for ten days start cycle day 6-7. |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- unfavorable vaginal microbiome using ARTPreds test
- non-smoker
Key exclusion criteria (3 listed)
- use of oral antibiotics oral probiotics between diagnosis and inclusion in the study
- pregnancy at inclusion
- allergy towards study drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vivag PlusContains two lactobacilli strains; l. gasseri and l. rhamnosus | Drug | Vivag Plus |
| Placebo - CapAlso: Placebo vaginal capsuleVaginal supplements | Drug | Placebo |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Derived from this study: PubMed 36531460Jepsen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vivag Plus in people with Implantation Failure and Infertility, Female, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in vaginal microbiome after intervention (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03843112, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.