Evidence map›Paper›PMID 36531460›Full record

Trial reportFrontiers in endocrinology2022

Probiotic treatment with specific lactobacilli does not improve an unfavorable vaginal microbiota prior to fertility treatment-A randomized, double-blinded, placebo-controlled trial.

Ida E Jepsen, Malene Hviid Saxtorph, Anne Lis Mikkelsen Englund, Kathrine Birch Petersen, Marie Louise Muff Wissing, Thomas Vauvert F Hviid, Nicholas Macklon

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Frontiers in endocrinology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03843112 (Modulating the Vaginal Microbiome After Implantation Failure A Randomized Placebo Controlled Study of Vaginal Lactobacilli Supplements), which is not on this map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03843112 phase4completednot on this map

Modulating the Vaginal Microbiome After Implantation Failure A Randomized Placebo Controlled Study of Vaginal Lactobacilli Supplements

TypeinterventionalSponsorZealand University HospitalRan2019 to 2021Enrolled74ConditionsImplantation Failure, Infertility, Female, Vaginal Flora ImbalanceArmsVivag Plus, Placebo - Cap
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Nutrients · 2025
    Trial
  3. Review
  4. Review
  5. Article
  6. Review
  7. Article
  8. All Properties of Infertility Microbiome in a Review Article.Journal of clinical laboratory analysis · 2025
    Review
  9. Flagellin in blood andiScience · 2025
    Article
  10. Review
  11. Review
  12. Review
  13. Review
  14. Review
  15. Effect ofMicroorganisms · 2023
    Article
  16. Article
  17. Review
  18. Article
  19. The Role of Hydrogen-Peroxide (HAntioxidants (Basel, Switzerland) · 2023
    Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Ida E JepsenThe Fertility Clinic, Department of Obstetrics and Gynecology, Zealand University Hospital, Koege, Denmark.
Malene Hviid SaxtorphThe Fertility Clinic, Department of Obstetrics and Gynecology, Zealand University Hospital, Koege, Denmark.
Anne Lis Mikkelsen EnglundThe Fertility Clinic, Department of Obstetrics and Gynecology, Zealand University Hospital, Koege, Denmark.
Kathrine Birch PetersenTFP Stork Fertility, The Fertility Partnership Denmark, Copenhagen, Denmark.
Marie Louise Muff WissingAleris-Hamlet Fertility, Aleris-Hamlet Hospital, Soeborg, Denmark.
Thomas Vauvert F HviidReproHealth Research Consortium, Zealand University Hospital, Roskilde, Denmark.
Nicholas MacklonThe Fertility Clinic, Department of Obstetrics and Gynecology, Zealand University Hospital, Koege, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective: To investigate whether treatment with proprietary lactobacilli-loaded vaginal capsules improves an unfavorable vaginal microbiome diagnosed using a commercially available test and algorithm. Design: A randomized, double-blinded, placebo-controlled study was conducted in 74 women prior to undergoing fertility treatment at a single university fertility clinic between April 2019 and February 2021. The women were randomly assigned in a 1:1 ratio to receive one vaginal capsule per day for 10 days containing either a culture of more than 10 Participants and methods: Women aged 18-40 years who prior to fertility treatment were diagnosed with an unfavorable vaginal microbiota, characterized by either a low relative load of Results: The vaginal microbiota improved after intervention in 34.2% of all participants (lactobacilli group 28.9%, placebo group 40.0%), with no significant difference in the improvement rate between the lactobacilli and placebo groups, RR = 0.72 (95% CI 0.38-1.38). Conclusion: This study indicates that administering vaginal probiotics may not be an effective means of modulating the vaginal microbiome for clinical purposes in an infertile population. However, a spontaneous improvement rate of 34.2% over a period of one to three months, confirming the dynamic nature of the vaginal microbiota, indicates that a strategy of postponing further IVF treatment to await microbiota improvement may be relevant in some patients, but further research is needed. Clinical trial registration: ClinicalTrials.gov, identifier NCT03843112.

Indexed as

MicrobiotaProbioticsVaginosis, BacterialFemaleHumansLactobacillusVaginaIVFlactobacillimicrobiomemicrobiotaprobioticsrandomized trialvagina

Identifiers

PMID36531460
PMCPMC9751370

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.