Literature DB >> 28573524

Use of various gonadotropin and biosimilar formulations for in vitro fertilization cycles: results of a worldwide Web-based survey.

Mindy S Christianson1, Gon Shoham2, Kyle J Tobler3, Yulian Zhao4, Brent Monseur5, Milton Leong6, Zeev Shoham7.   

Abstract

PURPOSE: The purpose of this study was to identify trends in gonadotropin therapy in patients undergoing in vitro fertilization (IVF) treatment worldwide.
METHODS: Retrospective evaluation utilizing the results of a Web-based survey, IVF-Worldwide ( www.IVF-worldwide.com ) was performed.
RESULTS: Three hundred fourteen centers performing a total of 218,300 annual IVF cycles were evaluated. Respondents representing 62.2% of cycles (n = 135,800) did not believe there was a difference between urinary and recombinant gonadotropins in terms of efficacy and live birth rate. Of the respondents, 67.3% (n = 146,800) reported no difference between recombinant and urinary formulations in terms of short-term safety and risk of ovarian hyperstimulation syndrome. In terms of long-term safety using human urinary gonadotropins, 50.6% (n = 110,400) of respondents believe there are potential long-term risks including prion disease. For 95.3% of units (n = 208,000), the clinician was the decision maker determining which specific gonadotropins are used for IVF. Of the units, 62.6% (n = 136,700) identified efficacy as the most important factor in deciding which gonadotropin to prescribe. While most (67.3%, n = 146,800) were aware of new biosimilar recombinant FSH products entering the market, 92% (n = 201,000) reported they would like more information. A fraction of respondents (25.6%, n = 55,900) reported having experience with these new products, and of these, 80.3% (n = 46,200) reported that they were similar in efficacy as previously used gonadotropins in a similar patient group.
CONCLUSIONS: Respondents representing the majority of centers do not believe a difference exists between urinary and recombinant gonadotropins with respect to efficacy and live birth rates. While many are aware of new biosimilar recombinant FSH products entering the market, over 90% desire more information on these products.

Entities:  

Keywords:  Assisted reproductive technology; Biosimilars; Controlled ovarian stimulation; Gonadotropins

Mesh:

Substances:

Year:  2017        PMID: 28573524      PMCID: PMC5533682          DOI: 10.1007/s10815-017-0952-0

Source DB:  PubMed          Journal:  J Assist Reprod Genet        ISSN: 1058-0468            Impact factor:   3.412


  16 in total

1.  Recombinant versus urinary gonadotrophin for ovarian stimulation in assisted reproductive technology cycles. A Cochrane review.

Authors:  Madelon van Wely; Irene Kwan; Anna L Burt; Jane Thomas; Andy Vail; Fulco Van der Veen; Hesham G Al-Inany
Journal:  Hum Reprod Update       Date:  2012-02-02       Impact factor: 15.610

2.  Continued improvements in the quality and consistency of follitropin alfa, recombinant human FSH.

Authors:  R M Bassett; R Driebergen
Journal:  Reprod Biomed Online       Date:  2005-02       Impact factor: 3.828

Review 3.  Biosimilars: opportunity or cause for concern?

Authors:  Simon D Roger; Ashraf Mikhail
Journal:  J Pharm Pharm Sci       Date:  2007       Impact factor: 2.327

4.  Prospective, randomized study comparing highly purified urinary follicle-stimulating hormone (FSH) and recombinant FSH for in vitro fertilization/intracytoplasmic sperm injection in patients with polycystic ovary syndrome.

Authors:  Mohamed Aboulghar; Waleed Saber; Yahia Amin; Mona Aboulghar; Ragaa Mansour; Gamal Serour
Journal:  Fertil Steril       Date:  2010-02-26       Impact factor: 7.329

5.  A multi-centre phase 3 study comparing efficacy and safety of Bemfola(®) versus Gonal-f(®) in women undergoing ovarian stimulation for IVF.

Authors:  M Rettenbacher; A N Andersen; J A Garcia-Velasco; M Sator; P Barri; S Lindenberg; K van der Ven; Y Khalaf; U Bentin-Ley; A Obruca; G Tews; M Schenk; T Strowitzki; N Narvekar; K Sator; B Imthurn
Journal:  Reprod Biomed Online       Date:  2015-01-27       Impact factor: 3.828

6.  Clinical efficacy of highly purified urinary FSH versus recombinant FSH in volunteers undergoing controlled ovarian stimulation for in vitro fertilization: a randomized, multicenter, investigator-blind trial.

Authors:  Valerie L Baker; Victor Y Fujimoto; L Michael Kettel; G David Adamson; Fred Hoehler; Clarence E Jones; Michael R Soules
Journal:  Fertil Steril       Date:  2008-03-25       Impact factor: 7.329

7.  Expression of biologically active human follitropin in Chinese hamster ovary cells.

Authors:  J L Keene; M M Matzuk; T Otani; B C Fauser; A B Galway; A J Hsueh; I Boime
Journal:  J Biol Chem       Date:  1989-03-25       Impact factor: 5.157

Review 8.  Gonadotrophins: The future.

Authors:  Madhuri Patil
Journal:  J Hum Reprod Sci       Date:  2014 Oct-Dec

9.  Biosimilar FSH preparations- are they identical twins or just siblings?

Authors:  Raoul Orvieto; David B Seifer
Journal:  Reprod Biol Endocrinol       Date:  2016-06-14       Impact factor: 5.211

10.  Randomized, active-controlled, comparative phase 3 efficacy and safety equivalence trial of Ovaleap® (recombinant human follicle-stimulating hormone) in infertile women using assisted reproduction technology (ART).

Authors:  Thomas Strowitzki; Waldemar Kuczynski; Arnd Mueller; Peter Bias
Journal:  Reprod Biol Endocrinol       Date:  2016-01-06       Impact factor: 5.211

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  4 in total

Review 1.  Management Strategies for POSEIDON Groups 3 and 4.

Authors:  Thor Haahr; Carlos Dosouto; Carlo Alviggi; Sandro C Esteves; Peter Humaidan
Journal:  Front Endocrinol (Lausanne)       Date:  2019-09-11       Impact factor: 5.555

2.  Effectiveness and safety of follitropin alfa (Ovaleap®) for ovarian stimulation using a GnRH antagonist protocol in real-world clinical practice: a multicenter, prospective, open, non-interventional assisted reproductive technology study.

Authors:  Peter Sydow; Norbert Gmeinwieser; Katrin Pribbernow; Christoph Keck; Inka Wiegratz
Journal:  Reprod Biol Endocrinol       Date:  2020-05-26       Impact factor: 5.211

Review 3.  Human Recombinant FSH and Its Biosimilars: Clinical Efficacy, Safety, and Cost-Effectiveness in Controlled Ovarian Stimulation for In Vitro Fertilization.

Authors:  Loredana Bergandi; Stefano Canosa; Andrea Roberto Carosso; Carlotta Paschero; Gianluca Gennarelli; Francesca Silvagno; Chiara Benedetto; Alberto Revelli
Journal:  Pharmaceuticals (Basel)       Date:  2020-06-27

4.  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.

Authors:  Klaus F Bühler; Robert Fischer; Patrice Verpillat; Arthur Allignol; Sandra Guedes; Emmanuelle Boutmy; Wilma Bilger; Emilia Richter; Thomas D'Hooghe
Journal:  Reprod Biol Endocrinol       Date:  2021-06-16       Impact factor: 5.211

  4 in total

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