Evidence map›Paper›PMID 39709390›Full record

Trial reportBMC pregnancy and childbirth2024

Oral dydrogesterone along with vaginal micronized progesterone supplementation for luteal phase support in IVF patients, and its impact on pregnancy and live birth rates: a prospective randomized trial.

Leonardo Rinaldi, Francesco Crescenzi, Helmy Selman

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC pregnancy and childbirth, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Effect of hysteroscopic cold -knife resection combined with dydrogesterone therapy on natural conception outcomes in women with endometrial polyps.Wideochirurgia i inne techniki maloinwazyjne = Videosurgery and other miniinvasive techniques · 2026
    Article
  2. 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

3 authors.

Leonardo RinaldiOne Day Medical Center, Via Attilio Ambrosini 114, Rome, 00147, Italy. leo.rinaldi@tiscali.it.
Francesco CrescenziOne Day Medical Center, Via Attilio Ambrosini 114, Rome, 00147, Italy.
Helmy SelmanOne Day Medical Center, Via Attilio Ambrosini 114, Rome, 00147, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA normal luteal function is an essential factor for maintaining pregnancy; luteal phase deficiency decreases embryo implantation and pregnancy rate and increases the early miscarriage rate. In stimulated in vitro fertilization-embryo transfer (IVF-ET) patients, luteal phase support (LPS) is achieved by the exogenous supplementation with progesterone to increase endometrial receptivity and pregnancy. While several protocols exist, no commonly accepted protocol has been established for optimal luteal support after IVF-ET to date, the purpose of this study was to investigate the effect of two different luteal phase support protocols in patients undergoing assisted reproductive technologies.

methodsIn a prospective open, randomized study conducted in a private IVF Unit a total of 700 infertile patients, undergoing in vitro fertilization treatment, were recruited for this study. All patients had a mild ovarian stimulation protocol with GnRH antagonist. The patients were randomized into two groups based on the type of luteal phase support route: Group A, control group (n = 310) patients received our routine LPS protocol which consists of the administration of 800 mg of micronized vaginal progesterone and Group B, study group, (n = 310) patients received a combination of oral dydrogesterone 20 mg and 90 mg of a gel of vaginal micronized progesterone Pregnancy rate, live birth rate, implantation rate and miscarriage rate were evaluated as primary endpoints. Statistical analysis was performed using JMP software (version 17; SAS, Inc., Cary, NC, USA). A P ≤ 0.05 was considered statistically significant.

resultsNo differences were observed between the two groups in terms of pregnancy rate (Group A 34,9% vs. Group B 35,7%), live birth rate (Group A 30,6% vs. Group B 29,2%), miscarriage rate (Group A 12% vs. Group B 18%) and implantation rate (Group A 18,6% vs. Group B 17,1%).

conclusionsThe combination of two different formulations of progesterone (vaginal and oral) for luteal phase support does not improve IVF outcomes when compared to the vaginal route of progesterone administration alone.

trial registrationThe study has been retrospectively registered with the Clinical Trials registry reference number ISRCTN52148405 ( http://isrctn.org/ ).

Indexed as

DydrogesteroneFertilization in VitroLive BirthLuteal PhasePregnancy RateProgesteroneProgestinsAdministration, IntravaginalAdministration, OralAdultBirth RateEmbryo TransferFemaleHumansOvulation InductionPregnancyDydrogesteroneProgesteroneProgestinsDydrogesteroneFollicle-stimulating hormoneGnRH antagonistLuteal phaseOvarian stimulationPregnancy

Identifiers

PMID39709390
PMCPMC11662462

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.