Evidence map›Paper›PMID 34134695›Full record

ArticleReproductive biology and endocrinology : RB&E2021

Comparative effectiveness of recombinant human follicle-stimulating hormone alfa (r-hFSH-alfa) versus highly purified urinary human menopausal gonadotropin (hMG HP) in assisted reproductive technology (ART) treatments: a non-interventional study in Germany.

Klaus F Bühler, Robert Fischer, Patrice Verpillat, Arthur Allignol, Sandra Guedes, Emmanuelle Boutmy, Wilma Bilger, Emilia Richter, Thomas D'Hooghe

Open access · goldAbstract readComparative Study
In one paragraph

Article in Reproductive biology and endocrinology : RB&E, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
3.3field-weighted citation impact, top 8% 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

5 citing papers in PubMed, 20 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. 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

9 authors at 3 institutions in 3 countries.

Klaus F BühlerDepartment of Gynaecology, Jena-University Hospital-Friedrich Schiller University, 07737, Jena, Germany.
Robert FischerGynecological Endocrinology and Reproductive Medicine, Fertility Centre Hamburg, 20095, Hamburg, Germany.
Patrice VerpillatGlobal Epidemiology, Research and Development, Merck KGaA, Frankfurter Strasse 250, 64293, Darmstadt, Germany.
Arthur AllignolGlobal Epidemiology, Research and Development, Merck KGaA, Frankfurter Strasse 250, 64293, Darmstadt, Germany.
Sandra GuedesGlobal Epidemiology, Research and Development, Merck KGaA, Frankfurter Strasse 250, 64293, Darmstadt, Germany.
Emmanuelle BoutmyGlobal Epidemiology, Research and Development, Merck KGaA, Frankfurter Strasse 250, 64293, Darmstadt, Germany.
Wilma BilgerMedical Affairs Fertility, Endocrinology and General Medicine, Merck Serono GmbH, an affiliate of Merck KGaA, Darmstadt, Germany, Alsfelder Str. 17, 64289, Darmstadt, Germany.
Emilia RichterGlobal Medical Affairs Fertility, Research and Development, Merck KGaA, Frankfurter Strasse 250, 64293, Darmstadt, Germany.
Thomas D'HoogheGlobal Medical Affairs Fertility, Research and Development, Merck KGaA, Frankfurter Strasse 250, 64293, Darmstadt, Germany. thomas.dhooghe@merckgroup.com.
Merck (Germany) · DEEndometriosis · GBFriedrich Schiller University Jena · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study compared the effectiveness of recombinant human follicle-stimulating hormone alfa (r-hFSH-alfa; GONAL-f

methodsData were collected from 71 German fertility centres between 01 January 2007 and 31 December 2012, for women undergoing a first stimulation cycle of ART treatment with r-hFSH-alfa or hMG HP. Primary outcomes were live birth, ongoing pregnancy and clinical pregnancy, based on cumulative data (fresh and frozen-thawed embryo transfers), analysed per patient (pP), per complete cycle (pCC) and per first complete cycle (pFC). Secondary outcomes were pregnancy loss (analysed per clinical pregnancy), cancelled cycles (analysed pCC), total drug usage per oocyte retrieved and time-to-live birth (TTLB; per calendar week and per cycle).

resultsTwenty-eight thousand six hundred forty-one women initiated a first treatment cycle (r-hFSH-alfa: 17,725 [61.9%]; hMG HP: 10,916 [38.1%]). After adjustment for confounding variables, treatment with r-hFSH-alfa versus hMG HP was associated with a significantly higher probability of live birth (hazard ratio [HR]-pP [95% confidence interval (CI)]: 1.10 [1.04, 1.16]; HR-pCC [95% CI]: 1.13 [1.08, 1.19]; relative risk [RR]-pFC [95% CI]: 1.09 [1.05, 1.15], ongoing pregnancy (HR-pP [95% CI]: 1.10 [1.04, 1.16]; HR-pCC [95% CI]: 1.13 [1.08, 1.19]; RR-pFC [95% CI]: 1.10 [1.05, 1.15]) and clinical pregnancy (HR-pP [95% CI]: 1.10 [1.05, 1.14]; HR-pCC [95% CI]: 1.14 [1.10, 1.19]; RR-pFC [95% CI]: 1.10 [1.06, 1.14]). Women treated with r-hFSH-alfa versus hMG HP had no statistically significant difference in pregnancy loss (HR [95% CI]: 1.07 [0.98, 1.17], were less likely to have a cycle cancellation (HR [95% CI]: 0.91 [0.84, 0.99]) and had no statistically significant difference in TTLB when measured in weeks (HR [95% CI]: 1.02 [0.97, 1.07]; p = 0.548); however, r-hFSH-alfa was associated with a significantly shorter TTLB when measured in cycles versus hMG HP (HR [95% CI]: 1.07 [1.02, 1.13]; p = 0.003). There was an average of 47% less drug used per oocyte retrieved with r-hFSH-alfa versus hMG HP.

conclusionsThis large (> 28,000 women), real-world study demonstrated significantly higher rates of cumulative live birth, cumulative ongoing pregnancy and cumulative clinical pregnancy with r-hFSH-alfa versus hMG HP.

Indexed as

Reproductive Techniques, AssistedAdultDatabases, FactualFemaleFollicle Stimulating Hormone, HumanGermanyGlycoprotein Hormones, alpha SubunitHumansInfertility, FemaleLive BirthMenotropinsPregnancyTreatment OutcomeFollicle Stimulating Hormone, HumanGlycoprotein Hormones, alpha SubunitMenotropinsFollitropin alfa, GONAL-fHuman menopausal gonadotropin (hMG)Menogon HPReal-world dataRecombinant human follicle-stimulating hormone (r-hFSH)

Identifiers

PMID34134695
PMCPMC8207759
OpenAlexW3172386138

What OpenQuestion holds

Textmetadata
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.