Review of the safety, efficacy, costs and patient acceptability of recombinant follicle-stimulating hormone for injection in assisting ovulation induction in infertile women

International Journal of Women's Health

Volumn 1, Issue 1, 2009, Pages 205-211

  Nahuis, Marleen ^a,b,c   Van Der Veen, Fulco ^a   Oosterhuis, Jur ^b   Mol, Ben Willem ^a   Hompes, Peter ^c   Van Wely, Madelon ^a  

^a UNIVERSITY OF AMSTERDAM   (Netherlands)

^b MEDISCH SPECTRUM TWENTE   (Netherlands)

^c VU UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

Follitropin apha; Follitropin beta; Polycystic ovary syndrome; Urinary gonadotropins

Indexed keywords

CLOMIFENE; CLOMIFENE CITRATE; FOLLITROPIN; FOLLITROPIN ALPHA; GONADOTROPIN; HUMAN MENOPAUSAL GONADOTROPIN; LUTEINIZING HORMONE; RECOMBINANT FOLLITROPIN; UNCLASSIFIED DRUG; UROFOLLITROPIN;

ANOVULATION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DRUG COST; DRUG EFFICACY; DRUG HALF LIFE; DRUG METABOLISM; DRUG PURIFICATION; DRUG SAFETY; DRUG SELF ADMINISTRATION; DRUG STRUCTURE; DRUG SYNTHESIS; FEMALE INFERTILITY; HUMAN; INJECTION SITE CONTUSION; INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; INJECTION SITE PRURITUS; MULTIPLE CYCLE TREATMENT; MULTIPLE PREGNANCY; OVARY HYPERSTIMULATION; OVARY INSUFFICIENCY; OVULATION INDUCTION; PATIENT ATTITUDE; PATIENT SAFETY; PREGNANCY OUTCOME; PREGNANCY RATE; RANDOMIZED CONTROLLED TRIAL; REVIEW; STRUCTURE ACTIVITY RELATION;

EID: 77953429804     PISSN: None     EISSN: 11791411     Source Type: Journal    
DOI: None     Document Type: Review

References (39)

1. Hull MG, Glazener CM, Kelly NJ, et al. Population study of causes, treatment, and outcome of infertility. Br Med J (Clin Res Ed). 1985;291:1693-1697.
2. Gemzell CA, Diczfalusy E, Tillinger G. Clinical effect of human pituitary follicle-stimulating hormone (FSH). J Clin Endocrinol Metab. 1958;18:1333-1348.
3. Lunenfeld B, Menzi A, Volet B. Clinical effects of a human postmenopausal gonadotropin. Rass Clin Ter. 1960;59:213-216.
4. Balen AH, Hayden CJ, Rutherford AJ. What are the clinical benefits of recombinant gonadotrophins? Clinical efficacy of recombinant gonadotrophins. Hum Reprod. 1999;14:1411-1417.
5. Reichl H, Balen A, Jansen CA. Prion transmission in blood and urine: what are the implications for recombinant and urinary-derived gonadotrophins? Hum Reprod. 2002;17:2501-2508.
6. Shaked GM, Shaked Y, Kariv-Inbal Z, Halimi M, Avraham I, Gabizon R. A protease-resistant prion protein isoform is present in urine of animals and humans affected with prion diseases. J Biol Chem. 2001;276:31479-31482.
7. Serban A, Legname G, Hansen K, Kovaleva N, Prusiner SB. Immunoglobulins in urine of hamsters with scrapie. J Biol Chem. 2004;279:48817-48820.
8. Gleicher N, Vietzke M, Vidali A. Bye-bye urinary gonadotrophins? Recombinant FSH: a real progress in ovulation induction and IVF? Hum Reprod. 2003;18:476-482.
9. Albano C, Smitz J, Camus M, Coelingh Bennink H VSA, Devroey P. Pregnancy and birth in an in vitro fertilisation cycle after controlled ovarian stimulation in a women with a histroy of allergic reactions to human menopausal gonadotropins. Hum Reprod. 1996;11(8):1632-1634.
10. Hard K, Mekking A, Damm JB et al. Isolation and structure determination of the intact sialylated N-linked carbohydrate chains of recombinant human follitropin expressed in Chinese hamster ovary cells. Eur J Biochem. 1990;193:263-271.
11. Barrios-De-Tomasi J, Timossi C, Merchant H, et al. Assessment of the in vitro and in vivo biological activities of the human follicle-stimulating isohormones. Mol Cell Endocrinol. 2002;186:189-198.
12. Creus S, Chaia Z, Pellizzari EH, Cigorraga SB, Ulloa-Aguirre A, Campo S. Human FSH isoforms: carbohydrate complexity as determinant of in-vitro bioactivity. Mol Cell Endocrinol. 2001;174:41-49.
13. Ulloa-Aguirre A, Zambrano E, Timossi C, et al. On the nature of the follicle-stimulating signal delivered to the ovary during exogenously controlled follicular maturation. A search into the immunological and biological attributes and the molecular composition of two preparations of urofollitropin. Arch Med Res. 1995;26 Spec No:S219-S230.
14. Gordon K. New developments in gonadotrophin pharmacology. Reprod Biomed Online. 2002;5:259-264.
15. World Health Organisation. WHO manual for the standardized investigation and diagnosis of the infertile couple. Cambridge: Cambridge University Press; 1993.
16. ESHRE Capri Workshop Group. Mono-ovulatory cycles: a key gole in profertility programmes. Hum Reprod Update. 2003;9:263-274.
17. Rowe PJ, Comhaire FA, Hargreave TB, Mellow HJ. WHO manual for the standardized investigation and diagnosis of the infertile couple. Cambridge: Cambridge University Press. 1997;1-80.
18. Kousta E, White DM, Piazzi A, Loumaye E, Franks S. Successful induction ovulation and completed pregnancy using recombinant human luteinizing hormone and follicle stimulating hormone in a woman with Kallmann's syndrome. Hum Reprod. 1996;11:70-71.
19. Rotterdam ESHRE/ASRM-Sponsored PCOS consensus workshop group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS). Hum Reprod. 2004;19:41-47.
20. Homburg R, Howles CM. Low-dose FSH therapy for anovulatory infertility associated with polycystic ovary syndrome: rationale, results, reflections and refinements. Hum Reprod Update. 1999;5:493-499.
21. Speroff. The Clinical Gynecologic Endocrinology and Infertility. 7 ed. 2004:897-930.
22. Hugues JN, Cedrin-Durnerin I, Howles CM, et al. The use of a decremental dose regimen in patients treated with a chronic low-dose step-up protocol for WHO Group II anovulation: a prospective randomized multicentre study. Hum Reprod. 2006;21:2817-2822.
23. Balen AH, Platteau P, Andersen AN, et al. The influence of body weight on response to ovulation induction with gonadotrophins in 335 women with World Health Organization group II anovulatory infertility. BJOG. 2006;113:1195-1202.
24. van Wely M, Bayram N, van der Veen F. Recombinant FSH in alternative doses or versus urinary gonadotrophins for ovulation induction in subfertility associated with polycystic ovary syndrome: a systematic review based on a Cochrane review. Hum Reprod. 2003;18:1143-1149.
25. Loumaye E, Martineau I, Piazzi A, et al. Clinical assessment of human gonadotrophins produced by recombinant DNA technology. Hum Reprod. 1996;11 Suppl 1:95-107.
26. Yarali H, Bukulmez O, Gurgan T. Urinary follicle-stimulating hormone (FSH) versus recombinant FSH in clomiphene citrate-resistant, normogonadotropic,chronic anovulation: a prospective randomized study. Fertil Steril. 1999;72:276-281.
27. Coelingh Bennink HJ, Fauser BC, Out HJ. Recombinant follicle-stimulating hormone (FSH; Puregon) is more efficient than urinary FSH (Metrodin) in women with clomiphene citrate-resistant, normogonadotropic, chronic anovulation: a prospective, multicenter, assessor-blind, randomized, clinical trial. European Puregon Collaborative Anovulation Study Group. Fertil Steril. 1998;69:19-25.
28. Balen A, Platteau P, Andersen AN, Devroey P, Helmgaard L, Arce JC. Highly purified FSH is as efficacious as recombinant FSH for ovulation induction in women with WHO Group II anovulatory infertility: a randomized controlled non-inferiority trial. Hum Reprod. 2007;22:1816-1823.
29. Gerli S, Casini ML, Unfer V, Costabile L, Mignosa M, Di Renzo GC. Ovulation induction with urinary FSH or recombinant FSH in polycystic ovary syndrome patients: a prospective randomized analysis of cost-effectiveness. Reprod Biomed Online. 2004;9:494-499.
30. Platteau P, Andersen AN, Balen A, et al. Similar ovulation rates, but different follicular development with highly purified menotrophin compared with recombinant FSH in WHO Group II anovulatory infertility: a randomized controlled study. Hum Reprod. 2006;21:1798-1804.
31. Revelli A, Poso F, Gennarelli G, Moffa F, Grassi G, Massobrio M. Recombinant versus highly-purified, urinary follicle stimulating hormone (r-FSH vs HP-uFSH) in ovulation induction: a prospective, randomized study with cost minimization analysis. Reprod Biol Endocrinol. 2006;18 (4):38.
32. Ricci G, Cerneca F, Simeone R, et al. Impact of highly purified urinary FSH and recombinant FSH on haemostasis: an open-label, randomized, controlled trial. Hum Reprod. 2004;19:838-848.
33. Szilagyi A, Bartfai G, Manfai A, Koloszar A, Pal A, Szabo I. Low dose ovulation induction with urinary gonadotropins or recombinant follicle stimulating hormone in patients with polycystic ovary syndrome. Gynecol Endocrinol. 2004;18:17-22.
34. Klip H, Burger CW, Kenemans P, van Leeuwen FE. Cancer risk associated with subfertility and ovulation induction: a review. Cancer Causes Control. 2000;11(4):319-344.
35. Salhab M, Al Sarakbi W, Mokbel K. In vitro fertilization and breast cancer: a review. Int J Fertil Womens Med. 2005;50(6):259-266.
36. Weiss N. Gonadotrophin products: empowering patients to choose the product that meets their needs. Reprod Biomed Online. 2007;15 (1):31-37.
37. Somkoti SG, Schertz JC, Moore M, Ferrande L, Kelly E, The gonal-F prefilled pen in OI study 24785 group. Patient experience with follitropin alfa prefilled pen versus previously used injectable gonadotropins for ovulation induction in oligoanovulatory women. Curr Med Res Opin. 2006;22(10):1981-1986.
38. Aghssa MM, Azargoon A, Ramezanzadeh F, Bagheri M. A comparison of the efficacy, tolerability, and convenience of two formulations of follitropin-alpha in Iranian woman undergoing intracytoplasmic sperm injection cycles. Fertil Steril. 2008;90:1043-1048.
39. Porter R, Kissel C, Saunders H, Keck C. Patients and nurse evaluation of recombinant follicle stimulating hormone administration methods: a comparison of two follitropin injection pens. Curr Med Res Opin. 2008;24(3):727-735.