Evidence map›Paper›PMID 39956097›Full record

Trial reportGynecologic and obstetric investigation2025

Progesterone Vaginal Gel or Combined Medication for Luteal-Phase Support of Frozen-Thawed Embryo Transfer Cycles: A Single-Centre, Chinese, Randomized, Open-Label, Pilot Study.

Rui Yang, Ningning Pan, Xiumei Zhen, Yanhong Fan, Jianhuai Zheng, Yuanyuan Wang, Qiao Liu, Xun Liao, Rui Yang

Abstract readRandomized Controlled TrialClinical Trial, Phase IV
In one paragraph

Trial report in Gynecologic and obstetric investigation, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

9 authors.

Rui Yang
Ningning PanCentre for Reproductive Medicine, Department of Obstetrics and Gynaecology, Peking University Third Hospital Beijing, Beijing, China, pnn1210@126.com.
Xiumei ZhenCentre for Reproductive Medicine, Department of Obstetrics and Gynaecology, Peking University Third Hospital Beijing, Beijing, China.
Yanhong FanCentre for Reproductive Medicine, Department of Obstetrics and Gynaecology, Peking University Third Hospital Beijing, Beijing, China.
Jianhuai ZhengCentre for Reproductive Medicine, Department of Obstetrics and Gynaecology, Peking University Third Hospital Beijing, Beijing, China.
Yuanyuan WangCentre for Reproductive Medicine, Department of Obstetrics and Gynaecology, Peking University Third Hospital Beijing, Beijing, China.
Qiao LiuMedical Affairs, Merck Serono Co. Ltd., Beijing, China.
Xun LiaoMedical Affairs, Merck Serono Co. Ltd., Beijing, China.
Rui YangCentre for Reproductive Medicine, Department of Obstetrics and Gynaecology, Peking University Third Hospital Beijing, Beijing, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThis study aimed to explore potential differences in efficacy between vaginal progesterone (VPG) and VPG + oral progesterone (OPG) for luteal-phase support in hormone replacement therapy-frozen embryo transfer (HRT-FET) cycles.

designA single-centre, open-label, randomized controlled, phase IV pilot study was conducted. PARTICIPANTS/MATERIALS, SETTING,

methodsInfertile women aged 20-38 years undergoing HRT-FET cycles were included. Participants were randomized to VPG (n = 86) or VPG + OPG (n = 86). The primary efficacy endpoint was ongoing pregnancy at 10-12 weeks. Secondary efficacy endpoints included β-human chorionic gonadotropin (β-hCG) positivity, implantation rate, and clinical-pregnancy rate. Safety analyses included adverse events (AE) and vital signs.

resultsA higher ongoing pregnancy rate was observed with VPG + OPG (29.1%) versus VPG (18.8%); treatment difference 8.4% (90% confidence interval [CI] -2.2%, 19.0%). Numerical differences also favoured VPG + OPG over VPG for β-hCG positivity (0.9% [90% CI: -10.8%, 12.7%]), implantation (10.4% [90% CI: 0.5%, 21.3%]), and clinical pregnancy (10.1% [90% CI: -0.8%, 21.1%]). Incidences of treatment-emergent AEs were comparable. LIMITATIONS: The single-centre study was limited by a relatively small sample size which could have impacted the reported outcomes. Another limitation was the open-label design, which might have increased the risk of bias for subjective endpoints, such as AE reporting.

conclusionsA higher ongoing pregnancy rate was observed with VPG + OPG vs VPG; however, a statistical conclusion cannot be reached considering the small sample size. These data suggest that a minimum daily progesterone dose, such as VPG 90 mg + OPG 20 mg reported here, or VPG 180 mg reported in other studies, may be required for successful outcomes following HRT-FET cycles.

Indexed as

Embryo TransferInfertility, FemaleLuteal PhaseProgesteroneProgestinsAdministration, IntravaginalAdministration, OralAdultChinaCryopreservationEast Asian PeopleEmbryo ImplantationFemaleHumansPilot ProjectsPregnancyProgesteroneProgestinsVaginal Creams, Foams, and JelliesAssistedEmbryo transferInfertilityLuteal phaseProgesteroneReproductive techniques

Identifiers

PMID39956097
PMCPMC12500252

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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.