Evidence map›Paper›PMID 40259478›Full record

Trial reportBJOG : an international journal of obstetrics and gynaecology2025

Progesterone Luteal Support in Natural Cycles for Unexplained Infertility: A Randomised Controlled Trial (The PiNC Trial).

Claudia Raperport, Elpiniki Chronopoulou, Aviva Petrie, Roy Homburg, Elizabeth Timlick, Sheetal Barhate, Kristina Sackett, Priya Bhide

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in BJOG : an international journal of obstetrics and gynaecology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
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

8 authors.

Claudia RaperportWomen's Health Research Unit, Wolfson Institute of Population Health, Queen Mary University of London, London, UK.ORCID https://orcid.org/0000-0003-2969-2437
Elpiniki ChronopoulouCentre for Reproductive and Genetic Health, London, UK.
Aviva PetrieUniversity College London, London, UK.
Roy HomburgUniversity College London Hospital NHS Foundation Trust, London, UK.
Elizabeth TimlickHomerton Healthcare NHS Foundation Trust, London, UK.
Sheetal BarhateBarts Health NHS Trust, London, UK.
Kristina SackettFertility Plus, London, UK.
Priya BhideWomen's Health Research Unit, Wolfson Institute of Population Health, Queen Mary University of London, London, UK.

Funding

LD CollinsSPD Spark
6 · The paper itself

Abstract

objectiveTo compare the effect of luteal-phase progesterone supplementation in natural cycles to expectant management on live birth rates in women with unexplained infertility (UI).

designAn open-label, parallel-arm, single-centre randomised controlled trial.

settingOne tertiary NHS-funded fertility unit. POPULATION: Couples with UI for at least 1 year.

methodA comparison of luteal phase micronised vaginal progesterone treatment (400 mg bd) with timed intercourse and timed intercourse alone for 3 cycles.

main outcome measuresPrimary outcome: Livebirth rate. SECONDARY OUTCOMES: Biochemical pregnancy, clinical pregnancy, mid-luteal serum progesterone and pregnancy loss.

resultsOne hundred and forty-three couples were randomised. Livebirth rates were 11/72 (15.3%) in the treatment group versus 5/71 (7.0%) in the control group (RR 2.17, 95% CI 0.79-5.93). Biochemical pregnancy rates were 15/72 (20.8%) versus 10/71 (14.1%), (RR 1.48, 95% CI 0.72-3.07) and clinical pregnancy rates were 14/72 (19.4%) versus 9/71 (12.7%), (RR 1.53, 95% CI 0.71-3.31) in the treatment and control groups respectively. Pregnancy losses: 4/15 treatment group versus 5/10 control group (RR 0.53, 95% CI 0.19-1.51). One biochemical pregnancy loss in each group and 2/15 miscarriages in the treatment group versus 3/10 in the control group. Total miscarriage rates including biochemical losses were 3/15 (20%) versus 4/10 (40%) (RR 0.5, 95% CI 0.14-1.77).

conclusionsThe results did not reach statistical significance. However, the difference in livebirth rates warrants further investigation as this simple, noninvasive, inexpensive treatment would be a very attractive option for affected couples. A larger trial using the effect size from this study to guide sample size is planned.

trial registrationThe PiNC trial was registered with the EU Clinical Trials Register on 29/11/2019 www.clinicaltrialsregister.eu/ctr-search/search?query=homerton. The first participant was recruited on 25/2/2020.

Indexed as

Infertility, FemaleLuteal PhaseProgesteroneProgestinsAdministration, IntravaginalAdultFemaleHumansLive BirthPregnancyPregnancy RateWatchful WaitingProgesteroneProgestinsluteal phase defectprogesteroneunexplained infertility

Identifiers

PMID40259478
PMCPMC12232507

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.