Evidence map›Paper›PMID 26991890›Full record

SynthesisPloS one2016

Subcutaneous Progesterone Is Effective and Safe for Luteal Phase Support in IVF: An Individual Patient Data Meta-Analysis of the Phase III Trials.

Jakob Doblinger, Barbara Cometti, Silvia Trevisan, Georg Griesinger

Registry-linked trialOpen access · goldAbstract readMeta-Analysis
In one paragraph

Synthesis in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04365127 (A Single Center, Randomized, Controlled Trial of the Safety and Efficacy of Progesterone for the Treatment of COVID-19 in Hospitalized Men), which is not on this map. Cited by 20 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 4 pooled it
3.1field-weighted citation impact, top 10% 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.

NCT04365127 phase1completednot on this mapstarted 2020, after this paper: background citation

A Single Center, Randomized, Controlled Trial of the Safety and Efficacy of Progesterone for the Treatment of COVID-19 in Hospitalized Men

TypeinterventionalSponsorSara GhandehariRan2020 to 2020Enrolled40ConditionsCOVID-19, Sars-CoV2ArmsProgesterone 100 MG
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 4 syntheses or guidelines pooled it, 40 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Progestogen supplementation to prevent miscarriage: Evidence and controversies.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2026
    Review
  9. Article
  10. Progesterone: The Key Factor of the Beginning of Life.International journal of molecular sciences · 2022
    Review
  11. Article
  12. Key to Life: Physiological Role and Clinical Implications of Progesterone.International journal of molecular sciences · 2021
    Review
  13. Article
  14. Luteal-phase support in assisted reproductive technology: An ongoing challenge.International journal of reproductive biomedicine · 2021
    Review
  15. Article
  16. Article
  17. Article
  18. Review
  19. Article
  20. 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

4 authors at 3 institutions in 3 countries.

Jakob DoblingerDepartment of Obstetrics and Gynecology, Paracelsus Medical University, Salzburg, Austria.
Barbara ComettiIBSA Institut Biochimique SA, R&D Scientific Affairs, Lugano, Switzerland.
Silvia TrevisanIBSA Institut Biochimique SA, R&D Scientific Affairs, Lugano, Switzerland.
Georg GriesingerDepartment of Gynecological Endocrinology and Reproductive Medicine, University Hospital of Schleswig-Holstein, Campus Luebeck, Luebeck, Germany.
IBSA Institut Biochimique (Switzerland) · CHParacelsus Medical University · ATUniversity of Lübeck · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo summarize efficacy and safety data on a new progesterone compound which is available for subcutaneous administration as compared to vaginally administered progesterone for luteal phase support in patients undergoing IVF treatment.

designData from two randomized phase III trials (07EU/Prg06 and 07USA/Prg05) performed according to GCP standards with a total sample size of 1435 per-protocol patients were meta-analyzed on an individual patient data level.

settingUniversity affiliated reproductive medicine unit. PATIENTS: Subcutaneous progesterone was administered to a total of 714 subjects and vaginal progesterone was administered to a total of 721 subjects who underwent fresh embryo transfer after ovarian stimulation followed by IVF or ICSI. The subjects were between 18 and 42 years old and had a BMI <30 kg/m2.

interventionsSubcutaneous progesterone 25 mg daily vs. either progesterone vaginal gel 90 mg daily (07EU/Prg06) or 100 mg intravaginal twice a day (07USA/Prg05) for luteal phase support in IVF patients.

main outcome measuresOngoing pregnancy rate beyond 10 gestational weeks, live birth rate and OHSS risk.

resultsThe administration of subcutaneous progesterone versus intra-vaginal progesterone had no impact on ongoing pregnancy likelihood (OR = 0.865, 95% CI 0.694 to 1.077; P = n.s.), live birth likelihood (OR = 0.889, 95% CI 0.714 to 1.106; P = n.s.) or OHSS risk (OR = 0.995, 95% CI 0.565 to 1.754; P = n.s.) in regression analyses accounting for clustering of patients within trials, while adjusting for important confounders. Only female age and number of oocytes retrieved were significant predictors of live birth likelihood and OHSS risk.

conclusionNo statistical significant or clinical significant differences exist between subcutaneous and vaginal progesterone for luteal phase support.

Indexed as

Administration, IntravaginalAdultBirth RateClinical Trials, Phase III as TopicEmbryo TransferFemaleFertilization in VitroHumansLive BirthLuteal PhaseOvarian Hyperstimulation SyndromeOvulation InductionPregnancyPregnancy RateProgesteroneTreatment OutcomeProgesterone

Identifiers

PMID26991890
PMCPMC4798618
OpenAlexW2307344821

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.