Evidence map›Paper›PMID 33051228›Full record

ArticleBMJ open2020

Effect of clindamycin and a live biotherapeutic on the reproductive outcomes of IVF patients with abnormal vaginal microbiota: protocol for a double-blind, placebo-controlled multicentre trial.

Thor Haahr, Nina La Cour Freiesleben, Anja Pinborg, Henriette Svarre Nielsen, Vibeke Hartvig, Anne-Lis Mikkelsen, Thomas Parks, Niels Uldbjerg, Jørgen Skov Jensen, Peter Humaidan

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 31% of its field
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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Antibiotics prior to or at the time of embryo transfer in ART.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Trial
  3. Review
  4. Article
  5. Review
  6. Effect ofMicroorganisms · 2023
    Article
  7. 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

10 authors at 6 institutions in 2 countries.

Thor HaahrDepartment of Clinical Medicine, Aarhus Universitet, Aarhus, Denmark thohaa@rm.dk.ORCID 0000-0001-9304-5299
Nina La Cour FreieslebenThe Fertility Clinic, Hvidovre University Hospital, Copenhagen, Denmark.
Anja PinborgThe Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Henriette Svarre NielsenThe Fertility Clinic, Hvidovre University Hospital, Copenhagen, Denmark.
Vibeke HartvigStork Fertility Clinic, Copenhagen, Denmark.
Anne-Lis MikkelsenThe Fertility Clinic, Sjællands Universitetshospital Køge, Koge, Sjaelland, Denmark.
Thomas ParksOsel Inc, Mountain View, California, USA.
Niels UldbjergDepartment of Clinical Medicine, Aarhus Universitet, Aarhus, Denmark.
Jørgen Skov JensenDepartment of Reproductive Microbiology, Statens Serum Institute, Copenhagen, Denmark.ORCID 0000-0002-7464-7435
Peter HumaidanDepartment of Clinical Medicine, Aarhus Universitet, Aarhus, Denmark.ORCID 0000-0001-6884-5366
Aarhus University · DKHvidovre Hospital · DKCopenhagen University Hospital · DKOsel (United States) · USStatens Serum Institut · DKZealand University Hospital · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRecent studies in in vitro fertilisation (IVF) patients have associated abnormal vaginal microbiota (AVM) with poor clinical pregnancy rates of 6%-9% per embryo transfer. The biological plausibility for this finding is hypothesised to be ascending infection to the endometrium which in turn hampers embryo implantation. New molecular based diagnosis may offer advantages compared to microscopical diagnosis of AVM which has huge inter-study variability ranging from 4 to 38%; however, the important question is whether screening and treatment of AVM would improve reproductive outcomes in IVF patients. Herein, we describe a protocol for an ongoing double-blind, placebo-controlled multicentre trial of IVF patients diagnosed with AVM and randomised in three parallel groups 1:1:1. METHODS AND ANALYSIS: This is a drug intervention study where IVF patients will be screened for AVM, using a qPCR assay targeting ETHICS AND DISSEMINATION: All patients have to give informed consent. Dissemination of results is ensured in clinical trial agreements whether they be positive or not. Ethics committee, Central Denmark Region approved this protocol. TRIAL REGISTRATION NUMBER: ICH-GCP monitored trial, EudraCT 2016-002385-31; Pre-results.

Indexed as

ActinobacteriaMicrobiotaClindamycinEquivalence Trials as TopicFemaleFertilization in VitroHumansMulticenter Studies as TopicPregnancyRandomized Controlled Trials as TopicClindamycinbacterial vaginosisclindamycinGardnerellaIVFLactobacillusmicrobiotaRCT

Identifiers

PMID33051228
PMCPMC7554508
OpenAlexW3092000094

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.