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| Name | Class |
|---|---|
| ARTPred | UNKNOWN |
| Bifodan A/S | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vivag Plus | Active Comparator | Vivag Plus vaginal supplements one capsule every night for ten days start cycle day 6-7. |
|
| Placebo | Placebo Comparator | Placebo vaginal supplements one capsule every night for ten days start cycle day 6-7. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vivag Plus | Drug | Contains two lactobacilli strains; l. gasseri and l. rhamnosus |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fertilitetsklinikken, Region Sjælland | Køge | 4600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36531460 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 16, 2018 | Feb 12, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Randomised placebo controlled, double blinded study
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Participants, investigator, care providers and outcome assessors are all blinded until the end of inclusion af the last subject.
| Placebo - Cap |
| Drug |
Vaginal supplements |
|
|
| D000091662 | Genital Diseases |
| D007246 | Infertility |