Corifollitropin alfa: A new option to treat female infertility

Drugs of Today

Volumn 47, Issue 8, 2011, Pages 583-590

  De Lartigue, Jane ^a  

^a NONE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CETRORELIX; CHORIONIC GONADOTROPIN; CHORIONIC GONADOTROPIN BETA SUBUNIT; CORIFOLLITROPIN ALFA; ESTRADIOL; FOLLITROPIN; FOLLITROPIN RECEPTOR; GANIRELIX; GONADORELIN ANTAGONIST; INHIBIN B; LUTEINIZING HORMONE; PLACEBO; RECOMBINANT FOLLITROPIN;

ANOVULATION; ANTEPARTUM HEMORRHAGE; AREA UNDER THE CURVE; CARBOXY TERMINAL SEQUENCE; DOSE RESPONSE; DRUG ABSORPTION; DRUG DISTRIBUTION; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG EXCRETION; DRUG HALF LIFE; DRUG INDICATION; DRUG INDUCED HEADACHE; DRUG METABOLISM; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ECTOPIC PREGNANCY; EMBRYO TRANSFER; FEMALE; FEMALE INFERTILITY; FERTILIZATION IN VITRO; FOLLICULAR PHASE; HORMONAL REGULATION; HORMONE ACTION; HORMONE RECEPTOR INTERACTION; HORMONE RESPONSE; HUMAN; HYPOGONADOTROPIC HYPOGONADISM; IMMUNOGENICITY; INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; INJECTION SITE PRURITUS; INJECTION SITE SWELLING; INTRACYTOPLASMIC SPERM INJECTION; LOW DRUG DOSE; MAXIMUM PLASMA CONCENTRATION; MULTICENTER STUDY (TOPIC); NONHUMAN; OOCYTE MATURATION; OVARY FOLLICLE DEVELOPMENT; OVARY HYPERSTIMULATION; PAIN; PELVIS PAIN SYNDROME; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PREGNANCY COMPLICATION; PREGNANCY RATE; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SIDE EFFECT; SINGLE DRUG DOSE; TIME TO MAXIMUM PLASMA CONCENTRATION; URINARY EXCRETION;

EID: 80052808966     PISSN: 16993993     EISSN: 16994019     Source Type: Journal    
DOI: 10.1358/dot.2011.47.8.1635872     Document Type: Review

References (32)

1. Boivin, J., Bunting, L., Collins, J.A., Nygren, K.G. International estimates of infertility prevalence and treatment- seeking: potential need and demand for infertility medical care. Hum Reprod 2007, 22(6): 1506-12.
2. Stockell, H.A., Renwick, A.G. Molecular structures of glycoprotein hormones and functions of their carbohydrate components. Biochem J 1992, 287(3): 665-79.
3. Macklon, N.S., Stouffer, R.L., Giudice, L.C., Fauser, B.C. The science behind 25 years of ovarian stimulation for in vitro fertilization. Endocrin Rev 2006, 27(2): 170-207.
4. Land, J.A., Courtar, D.A., Evers, J.L. Patient dropout in an assisted reproductive technology program: implications for pregnancy rates. Fertil Steril 1997, 68(2): 278-81.
5. Weenen, C., Pena, J.E., Pollak, S.V. et al. Long-acting folliclestimulating hormone analogs containing N-linked glycosylation exhibited increased bioactivity compared with O-linked analogs in female rats. J Clin Endocrinol Metab 2004, 89(10): 5204-12.
6. Perlman, S., van den Hazel, B., Christiansen, J. et al. Glycosylation of an N-terminal extension prolongs the halflife and increases the in vivo activity of follicle stimulating hormone. J Clin Endocrinol Metab 2003, 88(7): 3227-35.
7. Papanikolaou, E.G., Kolibianakis, E., Devroey, P. Emerging drugs in assisted reproduction. Expert Opin Emerg Drugs 2005, 10(2): 425-40.
8. Matzuk, M.M., Hsueh, A.J., Lapolt, P.S., Tsafiri, A., Keene, J.L., Boime, I. The biological role of the carboxy-terminal extension of human chorionic gonadotropin β-subunit. Endocrinology 1990, 126(1): 376-83.
9. LaPolt, P.S., Nishimori, K., Fares, F.A., Perlas, E., Boime, I., Hsueh, A.J. Enhanced stimulation of follicle maturation and ovulatory potential by long acting follicle-stimulating hormone agonists with extended carboxyl-terminal peptides. Endocrinology 1992, 131(6): 2514-20.
10. Fares, F.A., Suganuma, N., Nishimori, K., LaPolt, P.S., Hsueh, A.J., Boime, I. Design of a long-acting follitropin agonist by fusing the C-terminal sequence of the chorionic gonadotropin β-subunit to the follitropin β-subunit. Proc Natl Acad Sci U S A 1992, 89(10): 4304-8.
11. Duijkers, I.J.M., Klipping, C., Boerrigter, P.J., Machielsen, C.S.M., de Bie, J.J., Voortman, G. Single dose pharmacokinetics and effects on follicular growth and serum hormones of a long-acting recombinant FSH preparation (FSH-CTP) in healthy pituitary-suppressed females. Hum Reprod 2002, 17(8): 1987-93.
12. Verbost, P., Sloot, W.N., Rose, U.M., de Leeuw, R., Hanssen, R.G., Verheijden, G.F. Pharmacologic profiling of corifollitropin alfa, the first developed sustained follicle stimulant. Eur J Pharmacol 2011, 651(1-3): 227-33.
13. van Schanke, A., van de Wetering-Krebbers, S.F.M., Bos, E., Sloot, W.N. Absorption, distribution, metabolism and excretion of corifollitropin alfa, a recombinant hormone with a sustained follicle-stimulating activity. Pharmacology 2010, 85(2): 77-87.
14. Bouloux, P.M., Handelsman, D.J., Jockenhovel, F. et al. First human exposure to FSH-CTP in hypogonadotrophic hypogonadal males. Hum Reprod 2001, 16(8): 1592-7.
15. Devroey, P., Fauser, B.C., Platteau, P., Beckers, N.G., Dhont, M., Mannaerts, B. Induction of multiple follicular development by a single dose of long-acting recombinant folliclestimulating hormone (FSH-CTP, corifollitropin alfa) for controlled ovarian stimulation before in vitro fertilization. J Clin Endocrinol Metab 2004, 89(5): 2062-70.
16. Balen, A.H., Mulders, A.G., Fauser, B.C. et al. Pharmacodynamics of a single low dose of long-acting recombinant follicle-stimulating hormone (FSH-carboxy terminal peptide, corifollitropin alfa) in women with World Health Organization group II anovulatory infertility. J Clin Endocrinol Metab 2004, 89(12): 6297-304.
17. Corifollitropin Alfa Dose-finding Study Group. A randomized dose-response trial of a single injection of corifollitropin alfa to sustain multifollicular growth during controlled ovarian stimulation. Hum Reprod 2008, 23(11): 2484-92.
18. Mannaerts, B., de Haan, T., de Greef, R. Novel recombinant gonadotropin molecules in human reproductive dysfunction. 8th Eur Congr Endocrinol (April 1-5, Glasgow) 2006, Abst S29.
19. de Greef, R., Zandvliet, A.S., de Haan, A.F.J., Ijzerman-Boon, P.C., Marintcheva-Petrova, M., Mannaerts, B.M.J.L. Dose selection of corifollitropin alfa by modeling and simulation in controlled ovarian stimulation. Clin Pharmacol Ther 2010, 88(1): 79-87.
20. Fatemi, H.M., Oberye, J., Popovic-Todorovic, B., Witjes, H., Mannaerts, B., Devroey, P. Corifollitropin alfa in a long GnRH agonist protocol: proof of concept trial. Fertil Steril 2010, 94(5): 1922-4.
21. Fatemi, H.M., Oberye, J., Popovic-Todorovic, B., Witjes, H., Mannaerts, B. First results with corifollitropin alfa in a long GnRH agonist protocol. Hum Reprod [25th Annu Meet Eur Soc Hum Reprod Embryol (ESHRE) (June 28-July 1, Amsterdam) 2009] 2009, 24(Suppl. 1): O-283.
22. Fernandez Sanchez, M., Koper, N. Equally high ongoing pregnancy rates with corifollitropin alfa and recombinant FSH irrespective of variations in ART procedures. Hum Reprod [25th Annu Meet Eur Soc Hum Reprod Embryol (ESHRE) (June 28-July 1, Amsterdam) 2009] 2009, 24(Suppl. 1): Abst O-005.
23. Devroey, P., Boostanfar, R., Koper, N.P., Mannaerts, B.M.J.L., Ijzerman-Boon, P.C., Fauser, B.C.J.M. A double-blind, noninferiority RCT comparing corifollitropin alfa and recombinant FSH during the first seven days of ovarian stimulation using a GnRH antagonist protocol. Hum Reprod 2009, 24(12): 3063-72.
24. Fauser, B.C.J.M., Alper, M.M., Ledger, W., Schoolcraft, W.B., Zandvliet, A., Mannaerts, B.M.J.L. Pharmacokinetics and follicular dynamics of corifollitropin alfa versus recombinant FSH during ovarian stimulation for IVF. Reprod Biomed Online 2010, 21(5): 593-601.
25. Behr, B., Heijnen, E. Corifollitroping alfa versus recombinant FSH treatment for COS in a GnRH antagonist protocol: equal efficacy in terms of oocyte and embryo quality. Hum Reprod [25th Annu Meet Eur Soc Hum Reprod Embryol (ESHRE) (June 28-July 1, Amsterdam) 2009] 2009, 24(Suppl. 1): Abst O-003.
26. Corifollitropin alfa Ensure Study Group. Corifollitropin alfa for ovarian stimulation in IVF: a randomized trial in lowerbody- weight women. Reprod Biomed Online 2010, 21(1): 66-76.
27. Hillensjo, T., von Mauw, E. A comparison of corifollitropin vs recombinant FSH in a GnRH antagonist protocol for controlled ovarian stimulation in women weighing 60kg or less. Hum Reprod [25th Annu Meet Eur Soc Hum Reprod Embryol (ESHRE) (June 28-July 1, Amsterdam) 2009] 2009, 24(Suppl. 1): Abst O-004.
28. Rombauts, L., Heijnen, E., Marintcheva-Petrova, M., Elbers, J. Corifollitropin alfa is safe and efficacious in IVF patients undergoing repeated gonadotropin-releasing hormone antagonist ovarian stimulation cycles. 26th Annu Meet Eur Soc Hum Reprod Embryol (ESHRE) (June 27-30, Rome) 2010, Abst P-324.
29. Ledger, W., Zandvliet, A., Mannaerts, B. Two doses of corifollitropin alfa allow for similar exposure and ovarian response in patient weighing 60kg and >60kg. Hum Reprod [25th Annu Meet Eur Soc Hum Reprod Embryol (ESHRE) (June 28-July 1, Amsterdam) 2009] 2009, 24(Suppl. 1): Abst O-282.
30. Oberye, J., Passier, D., Mahony, M., Mannaerts, B., Bonduelle, M. Successful corifollitropin alfa treatment resulting in 500 live-born infants to date. Fertil Steril 2010, 93(5, Suppl. 1): Abst P-27.
31. Norman, R.J., Zegers-Hochschild, F., Salle, B.S., Elbers, J., Heijnen, E., Marintcheva-Petrova, M., Mannaerts, B. Repeated ovarian stimulation with corifollitropin alfa in patients in a GnRH antagonist protocol: no concern for immunogenicity. Hum Reprod 2011, 26(8): 2200-8.
32. European Medicines Agency. Elonva, corifollitropin alfa. EPAR summary for the public. http://www.ema.europa.eu/ docs/en-GB/document-library/EPAR--- Summary-for- the-public/human/001106/WC500074787.pdf. Accessed July 25, 2011.