Evidence map›Paper›PMID 40633953›Full record

ArticleBMJ open2025

ProVag: the effect of oral probiotics on the vaginal microbiota composition in women receiving medical assisted reproduction in a Dutch fertility clinic - protocol of a randomised, placebo-controlled, double-blind study.

Ashlee van Haren, S A Morre, Maria Stolaki, Jonathan de Jonge, Linda Stevens Brentjens, Ron van Golde

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. 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

6 authors.

Ashlee van HarenObstetriscs and Gynaecology, Maastricht University Medical Centre+, Maastricht, Netherlands ashlee.van.haren@mumc.nl.ORCID http://orcid.org/0009-0004-0574-6570
S A MorreGROW-Research Institute for Oncology and Reproduction, Maastricht University Faculty of Health Medicine and Life Sciences, Maastricht, Limburg, Netherlands.ORCID http://orcid.org/0000-0002-9953-0495
Maria StolakiProbiotics, Winclove BV, Amsterdam, Netherlands.
Jonathan de JongeARTPred BV, Oude Meer, Netherlands.
Linda Stevens BrentjensObstetriscs and Gynaecology, Maastricht University Medical Centre+, Maastricht, Netherlands.ORCID http://orcid.org/0000-0001-7650-8837
Ron van GoldeObstetriscs and Gynaecology, Maastricht University Medical Centre+, Maastricht, Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDifferences in the profile of the vaginal microbiota (VMB) have been associated with pregnancy rates after medical assisted reproduction (MAR) such as in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI). Monitoring the VMB profile of IVF patients creates an opportunity to identify the best window for IVF treatment and embryo transfer. The ReceptIVFity test is a predictive test that assesses the chances of becoming pregnant in women undergoing IVF treatment based on the VMB composition. A VMB profile dominated by beneficial strains, most notably METHODS AND ANALYSIS: This is a randomised, placebo-controlled, double-blind intervention study. The study will involve 1:1 randomisation to one of the two arms: oral probiotic or placebo. Vaginal and rectal swabs will be collected at intake and 4, 6 and 8 weeks after the start of the treatment. Our objective is to determine if oral probiotic treatment improves the VMB profile of IVF patients from a low to a medium/high ReceptIVFity score, compared with placebo treatment. Secondary outcomes are: the potential of the bacterial strains in the oral probiotic to be detected in the vaginal tract and/or in the gut, and if the treatment leads to an increased ongoing pregnancy rate after IVF. ETHICS AND DISSEMINATION: Ethical approval was obtained by the local medical ethical review committee at the Maastricht University Medical Centre. Findings from this study will be published in a peer-reviewed scientific journal and presented at one or more scientific conferences. TRIAL REGISTRATION NUMBER: CCMO NL81210.068.22, registered 25 September 2023.

Indexed as

Fertilization in VitroMicrobiotaProbioticsVaginaAdministration, OralAdultDouble-Blind MethodFemaleFertility ClinicsHumansLactobacillusNetherlandsPregnancyPregnancy RateRandomized Controlled Trials as TopicLactobacillus crispatusMicrobiotaRandomized Controlled TrialREPRODUCTIVE MEDICINE

Identifiers

PMID40633953
PMCPMC12243597

What OpenQuestion holds

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Registered trials

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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.