Evidence map›Paper›PMID 36339420›Full record

Trial reportFrontiers in endocrinology2022

Dose-dependent stimulation of human follicular steroidogenesis by a novel rhCG during ovarian stimulation with fixed rFSH dosing.

Jane Alrø Bøtkjær, Stine Gry Kristensen, Hanna Ørnes Olesen, Per Larsson, Bernadette Mannaerts, Claus Yding Andersen

Erratum issuedOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Frontiers in endocrinology, 2022. 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 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.6field-weighted citation impact, top 30% 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

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Jane Alrø BøtkjærLaboratory of Reproductive Biology, University Hospital of Copenhagen, Rigshospitalet, Copenhagen, Denmark.
Stine Gry KristensenLaboratory of Reproductive Biology, University Hospital of Copenhagen, Rigshospitalet, Copenhagen, Denmark.
Hanna Ørnes OlesenLaboratory of Reproductive Biology, University Hospital of Copenhagen, Rigshospitalet, Copenhagen, Denmark.
Per LarssonGlobal Biometrics, Ferring Pharmaceuticals A/S, Copenhagen, Denmark.
Bernadette MannaertsReproductive Medicine & Maternal Health, Ferring Pharmaceuticals A/S, Copenhagen, Denmark.
Claus Yding AndersenLaboratory of Reproductive Biology, University Hospital of Copenhagen, Rigshospitalet, Copenhagen, Denmark.
Rigshospitalet · DKFerring Pharmaceuticals (Denmark) · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Choriogonadotropin (CG) beta (FE 999302), a novel recombinant human (h)CG produced by a human cell line, has a longer half-life and higher potency than CG alfa produced by a Chinese hamster ovary cell line. hCG augments steroid production, but the extent of which CG beta treatment during ovarian stimulation (OS) increases steroidogenesis is unknown. Objective: To explore how increasing doses of CG beta during OS augment follicular steroidogenesis and change gene expression in cumulus cells. Study design: This study is part of a randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of CG beta plus recombinant follicle-stimulating hormone (rFSH) in women undergoing OS during a long gonadotrophin-releasing hormone agonist protocol. The study primary endpoint was intrafollicular steroid concentrations after CG beta administration. Secondary outcomes were gene expression of Participants/methods: 619 women with anti-Müllerian hormone levels 5-35 pmol/L were randomized to receive placebo or 1, 2, 4, 8, or 12 µg/day CG beta from Day 1 of OS plus rFSH. Follicular fluid (FF) (n=558), granulosa (n=498) and cumulus cells (n=368) were collected at oocyte retrieval. Steroid FF hormones were measured using enzyme-linked immunosorbent assays, gene expression was analyzed in cumulus cells by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) and single nucleotide polymorphism (SNP) analysis was performed in granulosa cells. Results: 17-OH-progesterone, androstenedione, testosterone, and estradiol concentrations significantly increased in a CG-beta dose-dependent manner during OS (p<0.0001), reaching up to 10 times higher values in the highest dose group versus placebo. There was no difference between CG beta dose groups and placebo for progesterone. Expression levels of Conclusions: These results reflect the importance of the combined effect of FSH and hCG/LH during OS on granulosa cell activity, follicle health and potentially oocyte quality. Trial Registration number: 2017-003810-13 (EudraCT Number). Trial Registration date: 21 May 2018. Date of first patient’s enrolment: 13 June 2018. Presented at the 38th Annual Meeting of the European Society of Human Reproduction and Embryology, P-567, 2022.

Indexed as

Cation Transport ProteinsProgesteroneAnimalsCHO CellsChorionic GonadotropinCricetinaeCricetulusFemaleFollicle Stimulating HormoneHumansMembrane GlycoproteinsOvulation InductionCation Transport ProteinsChorionic GonadotropinFollicle Stimulating HormoneMembrane GlycoproteinsProgesteroneRHCG protein, humancumulus cellsFE 999302ovarian stimulationrecombinant hCGsingle nucleotide polymorphismsSteroidogenesis

Identifiers

PMID36339420
PMCPMC9632659
OpenAlexW4306949732

What OpenQuestion holds

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LicenceCC BY
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.