Evidence map›Paper›PMID 31928963›Full record

Trial reportEBioMedicine2020

Impact of sitagliptin on endometrial mesenchymal stem-like progenitor cells: A randomised, double-blind placebo-controlled feasibility trial.

Shreeya Tewary, Emma S Lucas, Risa Fujihara, Peter K Kimani, Angela Polanco, Paul J Brighton, Joanne Muter, Katherine J Fishwick, Maria José Minhoto Diniz Da Costa, Lauren J Ewington and 4 more

Erratum issuedOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in EBioMedicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
3.0field-weighted citation impact, top 8% 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

23 citing papers in PubMed, 52 citations in OpenAlex.

  1. Article
  2. Endometriosis: An Immunologist's Perspective.International journal of molecular sciences · 2025
    Review
  3. Review
  4. Application of adult stem cells in obstetrics and gynecology: A scoping review.European journal of obstetrics & gynecology and reproductive biology: X · 2025
    Review
  5. Review
  6. Article
  7. Article
  8. Review
  9. Review
  10. Review
  11. Review
  12. Review
  13. Article
  14. Review
  15. EndoTime: non-categorical timing estimates for luteal endometrium.Human reproduction (Oxford, England) · 2022
    Article
  16. Use of 'omics for endometrial timing: the cycle moves on.Human reproduction (Oxford, England) · 2022
    Article
  17. Article
  18. Review
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 4 institutions in 2 countries.

Shreeya TewaryDivision of Biomedical Sciences, Clinical Science Research Laboratories, Warwick Medical School, University of Warwick, Coventry CV2 2DX, UK; Tommy's National Centre for Miscarriage Research, University Hospitals Coventry & Warwickshire, Coventry CV2 2DX, UK.
Emma S LucasDivision of Biomedical Sciences, Clinical Science Research Laboratories, Warwick Medical School, University of Warwick, Coventry CV2 2DX, UK; Tommy's National Centre for Miscarriage Research, University Hospitals Coventry & Warwickshire, Coventry CV2 2DX, UK.
Risa FujiharaDivision of Biomedical Sciences, Clinical Science Research Laboratories, Warwick Medical School, University of Warwick, Coventry CV2 2DX, UK; Department of Obstetrics & Gynaecology, Juntendo University, Faculty of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan.
Peter K KimaniDivision of Health Sciences, Warwick Medical School, University of Warwick, Coventry CV4 7AL, UK.
Angela PolancoTommy's National Centre for Miscarriage Research, University Hospitals Coventry & Warwickshire, Coventry CV2 2DX, UK.
Paul J BrightonDivision of Biomedical Sciences, Clinical Science Research Laboratories, Warwick Medical School, University of Warwick, Coventry CV2 2DX, UK.
Joanne MuterDivision of Biomedical Sciences, Clinical Science Research Laboratories, Warwick Medical School, University of Warwick, Coventry CV2 2DX, UK; Tommy's National Centre for Miscarriage Research, University Hospitals Coventry & Warwickshire, Coventry CV2 2DX, UK.
Katherine J FishwickDivision of Biomedical Sciences, Clinical Science Research Laboratories, Warwick Medical School, University of Warwick, Coventry CV2 2DX, UK.
Maria José Minhoto Diniz Da CostaDivision of Biomedical Sciences, Clinical Science Research Laboratories, Warwick Medical School, University of Warwick, Coventry CV2 2DX, UK; Tommy's National Centre for Miscarriage Research, University Hospitals Coventry & Warwickshire, Coventry CV2 2DX, UK.
Lauren J EwingtonDivision of Biomedical Sciences, Clinical Science Research Laboratories, Warwick Medical School, University of Warwick, Coventry CV2 2DX, UK; Tommy's National Centre for Miscarriage Research, University Hospitals Coventry & Warwickshire, Coventry CV2 2DX, UK.
Lauren LaceyDivision of Biomedical Sciences, Clinical Science Research Laboratories, Warwick Medical School, University of Warwick, Coventry CV2 2DX, UK; Tommy's National Centre for Miscarriage Research, University Hospitals Coventry & Warwickshire, Coventry CV2 2DX, UK.
Satoru TakedaDepartment of Obstetrics & Gynaecology, Juntendo University, Faculty of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan.
Jan J BrosensDivision of Biomedical Sciences, Clinical Science Research Laboratories, Warwick Medical School, University of Warwick, Coventry CV2 2DX, UK; Tommy's National Centre for Miscarriage Research, University Hospitals Coventry & Warwickshire, Coventry CV2 2DX, UK.
Siobhan QuenbyDivision of Biomedical Sciences, Clinical Science Research Laboratories, Warwick Medical School, University of Warwick, Coventry CV2 2DX, UK; Tommy's National Centre for Miscarriage Research, University Hospitals Coventry & Warwickshire, Coventry CV2 2DX, UK. Electronic address: S.Quenby@warwick.ac.uk.
University of Warwick · GBUniversity Hospital Coventry · GBJuntendo University · JPUniversity Hospitals Coventry and Warwickshire NHS Trust · GB

Funding

Medical Research Council MR/R014167/1
6 · The paper itself

Abstract

backgroundRecurrent pregnancy loss (RPL) is associated with the loss of endometrial mesenchymal stem-like progenitor cells (eMSC). DPP4 inhibitors may increase homing and engraftment of bone marrow-derived cells to sites of tissue injury. Here, we evaluated the effect of the DPP4 inhibitor sitagliptin on eMSC in women with RPL, determined the impact on endometrial decidualization, and assessed the feasibility of a full-scale clinical trial.

methodsA double-blind, randomised, placebo-controlled feasibility trial on women aged 18 to 42 years with a history of 3 or more miscarriages, regular menstrual cycles, and no contraindications to sitagliptin. Thirty-eight subjects were randomised to either 100 mg sitagliptin daily for 3 consecutive cycles or identical placebo capsules. Computer generated, permuted block randomisation was used to allocate treatment packs. Colony forming unit (CFU) assays were used to quantify eMSC in midluteal endometrial biopsies. The primary outcome measure was CFU counts. Secondary outcome measures were endometrial thickness, study acceptability, and first pregnancy outcome within 12 months following the study. Tissue samples were subjected to explorative investigations.

findingsCFU counts following sitagliptin were higher compared to placebo only when adjusted for baseline CFU counts and age (RR: 1.52, 95% CI: 1.32-1.75, P<0.01). The change in CFU count was 1.68 in the sitagliptin group and 1.08 in the placebo group. Trial recruitment, acceptability, and drug compliance were high. There were no serious adverse events. Explorative investigations showed that sitagliptin inhibits the expression of DIO2, a marker gene of senescent decidual cells.

interpretationSitagliptin increases eMSCs and decreases decidual senescence. A large-scale clinical trial evaluating the impact of preconception sitagliptin treatment on pregnancy outcome in RPL is feasible and warranted.

fundingTommy's Baby Charity. CLINICAL

trial registrationEU Clinical Trials Register no. 2016-001120-54.

Indexed as

Administration, OralAdultColony-Forming Units AssayDipeptidyl Peptidase 4Double-Blind MethodEndometriumFeasibility StudiesFemaleHumansMesenchymal Stem CellsPatient SelectionPlacebosPregnancyPregnancy OutcomeRegression AnalysisSitagliptin PhosphateDipeptidyl Peptidase 4DPP4 protein, humanPlacebosSitagliptin PhosphateDecidualizationEndometrium stem cellsMiscarriagePregnancyRandomised clinical trialSitagliptin

Identifiers

PMID31928963
PMCPMC7000352
OpenAlexW2999566525

What OpenQuestion holds

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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 OpenQuestion graph.