Evidence map›Paper›PMID 40467561›Full record

Trial reportNature communications2025

Efficacy of clindamycin and LACTIN-V for in vitro fertilization patients with vaginal dysbiosis: a randomised double-blind, placebo-controlled multicentre trial.

Thor Haahr, Nina la Cour Freiesleben, Mette Brix Jensen, Helle Olesen Elbaek, Birgit Alsbjerg, Rita Laursen, Lisbeth Prætorius, Henriette Svarre Nielsen, Anja Pinborg, Vibeke Hartvig Boujida and 4 more

Abstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Nature communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–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

7 citing papers in PubMed.

  1. Article
  2. Review
  3. Observational
  4. Article
  5. Article
  6. Review
  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

14 authors.

Thor HaahrDepartment of Clinical Medicine, Aarhus University, Denmark and the Fertility Clinic Skive, Skive Regional Hospital, Aarhus, Denmark. thohaa@rm.dk.ORCID http://orcid.org/0000-0001-9304-5299
Nina la Cour FreieslebenThe Fertility Clinic, Department of Obstetrics and Gynecology, Copenhagen University Hospital Hvidovre, Copenhagen, Denmark.ORCID http://orcid.org/0000-0002-5670-2015
Mette Brix JensenDepartment of Clinical Medicine, Aarhus University, Denmark and the Fertility Clinic Skive, Skive Regional Hospital, Aarhus, Denmark.
Helle Olesen ElbaekDepartment of Clinical Medicine, Aarhus University, Denmark and the Fertility Clinic Skive, Skive Regional Hospital, Aarhus, Denmark.
Birgit AlsbjergDepartment of Clinical Medicine, Aarhus University, Denmark and the Fertility Clinic Skive, Skive Regional Hospital, Aarhus, Denmark.
Rita LaursenDepartment of Clinical Medicine, Aarhus University, Denmark and the Fertility Clinic Skive, Skive Regional Hospital, Aarhus, Denmark.
Lisbeth PrætoriusThe Fertility Clinic, Department of Obstetrics and Gynecology, Copenhagen University Hospital Hvidovre, Copenhagen, Denmark.
Henriette Svarre NielsenThe Fertility Clinic, Department of Obstetrics and Gynecology, Copenhagen University Hospital Hvidovre, Copenhagen, Denmark.ORCID http://orcid.org/0000-0003-2106-8103
Anja PinborgDepartment of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.ORCID http://orcid.org/0000-0002-8340-104X
Vibeke Hartvig BoujidaStork Fertility Clinic, Copenhagen, Denmark.
Thomas Roland PedersenStatens Serum Institute, Research Unit for Reproductive Microbiology, Copenhagen, Denmark.
Axel Skafte-HolmStatens Serum Institute, Research Unit for Reproductive Microbiology, Copenhagen, Denmark.ORCID http://orcid.org/0000-0001-6759-2758
Jørgen Skov JensenStatens Serum Institute, Research Unit for Reproductive Microbiology, Copenhagen, Denmark.
Peter HumaidanDepartment of Clinical Medicine, Aarhus University, Denmark and the Fertility Clinic Skive, Skive Regional Hospital, Aarhus, Denmark. peter.humaidan@midt.rm.dk.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The primary aim of the present randomised, double-blind, placebo-controlled trial was to investigate whether clindamycin and live Lactobacillus crispatus CTV-05 (LACTIN-V) would improve clinical pregnancy rates in IVF patients with abnormal vaginal microbiota (AVM) defined by high quantitative PCR loads of Fannyhessea vaginae and Gardnerella spp. IVF patients were randomised prior to embryo transfer into three parallel groups 1:1:1. Group one (CLLA) received clindamycin 300 mg ×2 daily for 7 days followed by vaginal LACTIN-V until the day of pregnancy scan. Group two (CLPL) received clindamycin and placebo LACTIN-V, and finally, group three (PLPL) received an identical placebo of both drugs. A total of 1533 patients were screened, and 338 patients were randomised. The clinical pregnancy rates per embryo transfer were 42% (95%CI 32-52%), 46% (95%CI 36-56%) and 45% (95%CI 35-56%) in the CLLA, CLPL, PLPL groups respectively. Thus, treatment of AVM did not improve reproductive outcome. The EudraCT (European Union Drug Regulating Authorities Clinical Trials Database) clinical trial identifier is 2016-002385-31; first registration day 2016-07-11.

Indexed as

Anti-Bacterial AgentsBacteriocinsClindamycinDysbiosisFertilization in VitroLactobacillus crispatusProbioticsVaginaAdultDouble-Blind MethodEmbryo TransferFemaleHumansPregnancyPregnancy RateAnti-Bacterial AgentsBacteriocinsClindamycin

Identifiers

PMID40467561
PMCPMC12137813

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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 Socratic graph.