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01.08.2008 | Adis Drug Profile

Lutropin Alfa

verfasst von: Sohita Dhillon, Gillian M. Keating

Erschienen in: Drugs | Ausgabe 11/2008

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Abstract

▲ Lutropin alfa is the first and only recombinant human form of luteinizing hormone (LH) developed for use in the stimulation of follicular development.
▲ Dose-finding studies revealed a significant dosedependent increase in the rate of optimal follicular development among women with hypogonadotropic hypogonadism and profound LH deficiency (<1.2 IU/L) who received subcutaneous lutropin alfa 0–225 IU/day plus follitropin alfa.
▲ Similarly, in a double-blind, randomized study, the rate of optimal follicular development was significantly higher in women with hypogonadotropic hypogonadism and profound LH deficiency receiving subcutaneous lutropin alfa 75 IU/day plus follitropin alfa than in those receiving placebo plus follitropin alfa.
▲ Lutropin alfa with follitropin alfa may also be of benefit in certain subgroups of normogonadotropic women (e.g. those with an inadequate response to prior follitropin alfa monotherapy, those aged ≥35 years, and those with profound LH downregulation or who required excessive exogenous follitropin alfa). However, one study in older women (≥35 years) did not show any advantage of lutropin alfa supplementation.
▲ Once-daily subcutaneous lutropin alfa was generally well tolerated in hypogonadotropic hypogonadal women, with the majority of adverse events being of mild to moderate severity.

The use of trade names is for product identification purposes only and does not imply endorsement.

Serono S.A. Infertility in females [online]. Available from URL: http://www.fertility.com [Accessed 2006 Feb 1]

Hugues J. Current practices and controversies in assisted reproduction: ovarian stimulation for assisted reproduction technologies [online]. Available from URL: http://www.who.int/reproductive-health/infertility/report_content.htm [Accessed 2006 Feb 1]

Filicori M. Gonadotropin-releasing hormone analogs in ovulation induction: current status and perspectives. J Clin Endocrinol Metab 1996; 81(7): 2413–6PubMedCrossRef

Burgues S. The effectiveness and safety of recombinant human LH to support follicular development induced by recombinant human FSH in WHO group I anovulation: evidence from a multicentre study in Spain. Hum Reprod 2001; 16: 2525–32PubMedCrossRef

European Recombinant Human LHStudyGroup. Recombinant human luteinizing hormone (LH) to support recombinant human follicle-stimulating hormone (FSH)-induced follicular development in LH- and FSH-deficient anovulatory women: a dose-finding study. J Clin Endocrinol Metab 1998; 83: 1507–14CrossRef

Filicori M, Flamigni C, Dellai P, et al. Treatment of anovulation with pulsatile gonadotropin-releasing hormone: prognostic factors and clinical results in 600 cycles. J Clin Endocrinol Metab 1994; 79(4): 1215–20PubMedCrossRef

The ESHRE Capri Workshop Group. Anovulatory infertility. Hum Reprod 1995; 10(6): 1549–53CrossRef

Guidice E, Crisci C, Altarocca V, et al. Characterization of a partially purified human menopausal gonadotropin preparation. J Drug Assess 2001; 4(3): 171–8

Baer G, Loumaye E. Comparison of recombinant human luteinising hormone (r-hLH) and human menopausal gonadotropin (hMG) in assisted reproductive technology. Curr Med Res Opin 2003; 19(2): 83–8PubMed

10.

Rodgers M, Mitchell R, Lambert A, et al. Human chorionic gonadotropin contributes to the bioactivity of pergonal. Clin Endocrinol (Oxf) 1992; 37: 558–64CrossRef

11.

Filicori M, Cognigni G. Roles and novel regimens of luteinizing hormone and follicle stimulating hormone in ovulation induction. J Clin Endocrinol Metab 2001; 86(4): 1437–41PubMedCrossRef

12.

Alviggi C, Clarizia R, Mollo A, et al. Outlook: who needs LH in ovarian stimulation? Reprod Biomed Online 2006 May; 12(5): 599–607PubMedCrossRef

13.

Alviggi C, Mollo A, Clarizia R, et al. Exploiting LH in ovarian stimulation. Reprod Biomed Online 2006 Feb; 12(2): 221–33PubMedCrossRef

14.

Serono International SA. FDA Approves Serono’s Luveris® for concomitant use with Gonal-f® [media release]. 2004 Oct 15

15.

Serono. Luveris (lutropin for injection) for subcutaneous use: prescribing information [online]. Available from URL: http://www.fda.gov/cder/foi/label/2004/213221bl.pdf [Accessed 2008 Mar 26]

16.

Ludwig M. Does the addition of luteinizing hormone in ovarian stimulation protocols improve the outcome? Treat Endocrinol 2003; 2(5): 305–13PubMedCrossRef

17.

European Medicines Agency. Summary of product characteristics: pergoveris 150 IU/75 IU [online]. Available from URL: http://www.emea.europa.eu/humandocs/PDFs/EPAR/pergoveris/H-714-PI-en.pdf [Accessed 2008 Apr 23]

18.

Serono Europe Limited. Luveris: summary of product characteristics [online].Available from URL: http://www.emea.europa.eu/humandocs/PDFs/EPAR/Luveris/H-292-PI-en.pdf [Accessed 2008 Mar 26]

19.

Filicori M, Cognigni GE, Samara A, et al. The use of LH activity to drive folliculogenesis: exploring uncharted territories in ovulation induction. Hum Reprod Update 2002; 8(6): 543–57PubMedCrossRef

20.

O’Dea L. Recombinant LH in support of recombinant FSH in female hypogonadotropic hypogonadism: evidence of threshold effect [abstract no. O-093]. The US Recombinant Human L H Study Group. Fertil Steril 2000; 74 (3 Suppl. 1): S36CrossRef

21.

Hemsey F, O’Brien L, O’Dea L. Objective evidence of LH-dependence in women with profound LH and FSH deficiency [abstract no. P-292]. Fertil Steril 2001; 76 (3 Suppl. 1): S208CrossRef

22.

Kaufmann R, Dunn R, Vaughn T, et al. Recombinant human luteinizing hormone, lutropin alfa, for the induction of follicular development and pregnancy in the profoundly gonadotrophin-deficient women. Clin Endocrinol (Oxf) 2007; 67: 563–9

23.

Loumaye E, Engrand P, Shoham Z, et al. Clinical evidence for an LH ‘ceiling’ effect induced by administration of recombinant human LH during the late follicular phase of stimulated cycles in World Health Organization type I and type II anovulation. Hum Reprod 2003; 18: 314–22PubMedCrossRef

24.

Hugues J, Soussis J, Calderon I, et al. Does the addition of recombinant LH in WHO group II anovulatory women overresponding to FSH treatment reduce the number of developing follicles? A dose finding study. Hum Reprod 2005; 20(3): 629–35PubMedCrossRef

25.

Ruvolo G, Bosco L, Pane A, et al. Lower apoptosis rate in human cumulus cells after administration of recombinant luteinizing hormone to women undergoing ovarian stimulation for in vitro fertilization procedures. Fertil Steril 2007; 87(3): 542–6PubMedCrossRef

26.

De Placido G, Mollo A, Clarizia R, et al. Gonadotropin-releasing hormone (GnRH) antagonist plus recombinant luteinizing hormone vs. a standard GnRH agonist short protocol in patients at risk for poor ovarian response. Fertil Steril 2006 Jan; 85(1): 247–50

27.

le Cotonnec JY, Porchet HC, Beltrami V, et al. Clinical pharmacology of recombinant human luteinizing hormone: part I. Pharmacokinetics after intravenous administration to healthy female volunteers and comparison with urinary human luteinizing hormone. Fertil Steril 1998; 69: 189–94PubMedCrossRef

28.

le Cotonnec JY, Loumaye E, Porchet HC, et al. Pharmacokinetic and pharmacodynamic interactions between recombinant human luteinizing hormone and recombinant human folliclestimulating hormone. Fertil Steril 1998; 69: 201–9PubMedCrossRef

29.

le Cotonnec JY, Porchet HC, Beltrami V, et al. Clinical pharmacology of recombinant human luteinizing hormone: part II. Bioavailability of recombinant human luteinizing hormone assessed with an immunoassay and an in vitro bioassay. Fertil Steril 1998; 69: 195–200PubMedCrossRef

30.

Kousta E, White DM, Piazzi A, et al. Successful induction of ovulation and completed pregnancy using recombinant human luteinizing hormone and follicle stimulating hormone in a woman with Kallmann’s syndrome. Hum Reprod 1996; 11(1): 70–1PubMedCrossRef

31.

Hull M, Corrigan E, Piazzi A, et al. Recombinant human luteinising hormone: an effective new gonadotropin preparation. Lancet 1994; 344: 334–5PubMedCrossRef

32.

Balasch J, Fabregues F. Pregnancy after administration of high dose recombinant human LH alone to support final stages of follicular maturation in a woman with long-standing hypogonadotrophic hypogonadism. Reprod Biomed Online 2003; 6(4): 427–31PubMedCrossRef

33.

Lisi F, Rinaldi L, Fishel S, et al. Evaluation of two doses of recombinant luteinizing hormone supplementation in an unselected group of women undergoing follicular stimulation for in vitro fertilization. Fertil Steril 2005 Feb; 83(2): 309–15PubMedCrossRef

34.

Sills ES, Levy DP, Moomjy M, et al. A prospective, randomized comparison of ovulation induction using highly purified follicle-stimulating hormone alone and with recombinant human luteinizing hormone in in-vitro fertilization. Hum Reprod 1999; 14: 2230–5PubMedCrossRef

35.

Balasch J, Creus M, Fabregues F, et al. The effect of exogenous luteinizing hormone (LH) on oocyte viability: evidence from a comparative study using recombinant human follicle-stimulating hormone (FSH) alone or in combination with recombinant LH for ovarian stimulation in pituitary-suppressed women undergoing assisted reproduction. J Assist Reprod Genet 2001; 18: 250–6PubMedCrossRef

36.

Weigert M, Krischker U, Pohl M, et al. Comparison of stimulation with clomiphene citrate in combination with recombinant follicle-stimulating hormone and recombinant luteinizing hormone to stimulation with a gonadotropin-releasing hormone agonist protocol: a prospective, randomized study. Fertil Steril 2002; 78(1): 34–9PubMedCrossRef

37.

Humaidan P, Bungum M, Bungum L, et al. Effects of recombinant LH supplementation in women undergoing assisted reproduction with GnRH agonist down-regulation and stimulation with recombinant FSH: an opening study. Reprod Biomed Online 2004; 8(6): 635–43PubMedCrossRef

38.

Marrs R, Meldrum D, Muasher S, et al. Randomized trial to compare the effect of recombinant human FSH (follitropin alfa) with or without recombinant human LH in women undergoing assisted reproduction treatment. Reprod Biomed Online 2004; 8(2): 175–82PubMedCrossRef

39.

Griesinger G, SchultzeMosgau A, Dafopoulos K, et al. Recombinant luteinizing hormone supplementation to recombinant follicle-stimulating hormone induced ovarian hyperstimulation in the GnRH-antagonist multiple-dose protocol. Hum Reprod 2005; 20(5): 1200–6PubMedCrossRef

40.

Tarlatzis B, Tavmergen E, Szamatowicz M, et al. The use of recombinant human LH (lutropin alfa) in the late stimulation phase of assisted reproduction cycles: a double-blind, randomized, prospective study. Hum Reprod 2006 Jan; 21(1): 90–4PubMedCrossRef

41.

Nyboe Andersen A, Humaidan P, Fried G, et al. Recombinant LH supplementation to recombinant FSH during the final days of controlled ovarian stimulation for in vitro fertilization: a multicentre, prospective, randomized, controlled trial. Hum Reprod 2008; 23(2): 427–34CrossRef

42.

Sauer MV, Thornton 2nd MH, Schoolcraft W, et al. Comparative efficacy and safety of cetrorelix with or without mid-cycle recombinant LH and leuprolide acetate for inhibition of premature LH surges in assisted reproduction. Reprod Biomed Online 2004 Nov; 9(5): 487–93PubMedCrossRef

43.

Levi-Setti PE, Cavagna M, Bulletti C. Recombinant gonadotrophins associated with GnRH antagonist (cetrorelix) in ovarian stimulation for ICSI: comparison of r-FSH alone and in combination with r-LH. Eur J Obstet Gynecol Reprod Biol 2006 Jun 1; 126(2): 212–6PubMedCrossRef

44.

Barrenetxea G, Agirregoikoa JA, Jiménez MR, et al. Ovarian response and pregnancy outcome in poor-responder women: a randomized controlled trial on the effect of luteinizing hormone supplementation on in vitro fertilization cycles. Fertil Steril 2008; 89(3): 546–53PubMedCrossRef

45.

Mochtar MH, Van der Veen F, Ziech M, et al. Recombinant luteinizing hormone (rLH) for controlled ovarian hyperstimulation in assisted reproductive cycles (review). Cochrane Database Syst Rev 2007 Apr 18; (2): CD005070

46.

DePlacido G, Alviggi C, Perino A, et al. Recombinant human LH supplementation versus recombinant human FSH (rFSH) step-up protocol during controlled ovarian stimulation in normogonadotrophic women with initial inadequate ovarian response to rFSH: a multicentre, prospective, randomized controlled trial. Hum Reprod 2005; 20(2): 390–6PubMedCrossRef

47.

Ferraretti AP, Gianaroli MD, Magli MC, et al. Exogenous luteinizing hormone in controlled ovarian hyperStimulation for assisted reproduction techniques. Fertil Steril 2004; 82(6): 1521–6PubMedCrossRef

48.

Fabregues F, Creus M, Penarrubia J, et al. Effects of recombinant human luteinizing hormone supplementation on ovarian stimulation and the implantation rate in down-regulated women of advanced reproductive age. Fertil Steril 2006; 85(4): 925–31PubMedCrossRef

49.

Lisi F, Rinaldi L, Fishel S, et al. Use of recombinant LH in a group of unselected IVF patients. Reprod Biomed Online 2002; 5(2): 104–8PubMedCrossRef

50.

De Placido G, Alviggi C, Mollo A, et al. Effects of recombinant LH (rLH) supplementation during controlled ovarian hyperstimulation (COH) in normogonadotrophic women with an initial inadequate response to recombinant FSH (rFSH) after pituitary downregulation. Clin Endocrinol (Oxf) 2004 May; 60(5): 637–43CrossRef

Titel: Lutropin Alfa
verfasst von: Sohita Dhillon
Gillian M. Keating
Publikationsdatum: 01.08.2008
Verlag: Springer International Publishing
Erschienen in: Drugs / Ausgabe 11/2008
Print ISSN: 0012-6667
Elektronische ISSN: 1179-1950
DOI: https://doi.org/10.2165/00003495-200868110-00005

Live-Webinar "Urologie und Sexualmedizin in der Praxis"

Springer Medizin

Lutropin Alfa

Abstract

Live-Webinar "Urologie und Sexualmedizin in der Praxis"

Springer Medizin

Abstract

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