Fertility and Sterility
Volume 91, Issue 4 , Pages 1005-1011 , April 2009

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

  • Valerie L. Baker, M.D.

      Affiliations

    • Obstetrics and Gynecology, Stanford University Medical Center, Stanford, California
    • Fertility Physicians of Northern California, San Jose, California
    • Corresponding Author InformationReprint requests: Valerie L. Baker, M.D., Stanford University Medical Center, Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology and Infertility, 300 Pasteur Drive, Room HH333, Stanford, California 94305-5317 (FAX: 650-736-7036).
    • ,
  • Victor Y. Fujimoto, M.D.

      Affiliations

    • Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, California
    • ,
  • L. Michael Kettel, M.D.

      Affiliations

    • San Diego Fertility Center, San Diego, California
    • ,
  • G. David Adamson, M.D.

      Affiliations

    • Fertility Physicians of Northern California, San Jose, California
    • ,
  • Fred Hoehler, Ph.D.

      Affiliations

    • Biostatistician Consultant, Orange, California
    • ,
  • Clarence E. Jones, Ph.D.

      Affiliations

    • Consultant, Huntington Beach, California
    • ,
  • Michael R. Soules, M.D.

      Affiliations

    • Seattle Reproductive Medicine, Seattle, Washington

Received 18 October 2007 ,Revised 15 January 2008 ,Accepted 15 January 2008.

References 

  1. Macklon NS, Stouffer RL, Giudice LC, Fauser BCJM. The science behind 25 years of ovarian stimulation for in vitro fertilization. Endocr Rev. 2006;27:170–207
  2. Al-Inany H, Aboulghar M, Mansour R, Serour G. Meta-analysis of recombinant versus urinary-derived FSH: an update. Hum Reprod. 2003;18:305–313
  3. Loumaye E, Campbell R, Salat-Baroux J. Human follicle stimulating hormone produced by recombinant DNA technology: a review for clinicians. Hum Reprod Update. 1995;1:188–199
  4. Bayram N, van Wely M, van der Veen F. Recombinant FSH versus urinary gonadotrophins or recombinant FSH for ovulation induction in subfertility associated with polycystic ovarian syndrome. Cochrane Database Syst Rev. 2001;2:CD002121
  5. Balen A, Platteau P, Andersen AN, Devroey P, Helmgaard L, Arce J-C. 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
  6. Demirol A, Gurgan T. Comparison of different gonadotrophin preparations in intrauterine insemination cycles for the treatment of unexplained infertility: a prospective, randomized study. Hum Reprod. 2007;22:97–100
  7. van Wely M, Westergaard LG, Bossuyt PMM, van der Veen F. Effectiveness of human menopausal gonadotropin versus recombinant follicle stimulating hormone for controlled ovarian hyperstimulation in assisted reproductive cycles: a meta-analysis. Fertil Steril. 2003;80:1086–1093
  8. Kilani Z, Dakkak A, Ghunaim S, Cognigni GE, Tabarelli C, Parmegiani L, et al. A prospective, randomized, controlled trial comparing highly purified hMG with recombinant FSH in women undergoing ICSI: ovarian response and clinical outcomes. Hum Reprod. 2003;18:1194–1199
  9. Andersen AN, Devroey P, Arce J-C for the MERIT Group. Clinical outcome following stimulation with highly purified hMG or recombinant FSH in patients undergoing IVF; a randomized assessor-blind controlled trial. Hum Reprod. 2006;21:3217–3227
  10. Hompes PGA, Broekmans FJ, Hoozemans DA, Schats R for the FIRM group. Effectiveness of highly purified human menopausal gonadotropin vs. recombinant follicle-stimulating hormone in first-cycle in vitro fertilization-intracytoplasmic sperm injection patients. Fertil Steril. 2007;(in press)
  11. Mohamed MA, Sbracia M, Pacchiarotti A, Micara G, Linari A, Tranquilli D, et al. Urinary follicle-stimulating hormone (FSH) is more effective than recombinant FSH in older women in a controlled randomized study. Fertil Steril. 2006;85:1398–1403
  12. Selman HA, De Santo M, Sterzik K, Coccia E, El-Danasouri I. Effect of highly purified urinary follicle stimulating hormone on oocyte and embryo quality. Fertil Steril. 2002;78:1061–1067
  13. Pacchiarotti A, Aragona C, Gaglione R, Selman H. Efficacy of a combined protocol of urinary and recombinant follicle-stimulating hormone used for ovarian stimulation of patients undergoing ICSI cycle. J Assist Reprod Genet. 2007;24:400–405
  14. Anserini P, Costa M, Remorgida V, Venturini PL. A prospective, randomized, controlled clinical study of a new subcutaneous, purified, urinary FSH preparation for controlled ovarian hyperstimulation in in vitro fertilization. Gynecol Endocrinol. 2000;14:75–80
  15. Gerli S, Perino M, Abate A, Costabile L, Gholami H, Vitiello L. Ovarian stimulation using a new highly purified urinary FSH: a prospective randomized clinical study. Clin Exp Obstet Gynecol. 1999;26:93–94
  16. Gerli S. Ovulation induction with urinary FSH or recombinant FSH in polycystic ovarian syndrome patients: a prospective randomized analysis of cost-effectiveness. RBM Online. 2004;9:494–499
  17. Sibug RM, Datson N, Tijssen AMI, Morsink M, de Koning J, de Kloet ER, et al. Effects of urinary and recombinant gonadotrophins on gene expression profiles during the murine peri-implantation period. Hum Reprod. 2007;22:75–82
  18. Silverberg K, Daya S, Auray JP, Duru G, Ledger W, Wikland M, et al. Analysis of the cost effectiveness of recombinant versus urinary follicle-stimulating hormone in in vitro fertilization/intracytoplasmic sperm injection programs in the United States. Fertil Steril. 2002;77:107–113
  19. Hatoum HT, Keye WR, Marrs RP, Walton SM, Marshall DC. A Markov model of the cost-effectiveness of human-derived follicle-stimulating hormone (FSH) versus recombinant FSH using comparative clinical trial data. Fertil Steril. 2005;83:804–807
  20. Weiss N. Gonadotrophin products: empowering patients to choose the product that meets their needs. RBM Online. 2007;15:31–37
  21. Arce J-C, Andersen AN, Collins J. Resolving methodological and clinical issues in the design of efficacy trials in assisted reproductive technologies: a mini-review. Hum Reprod. 2005;20:1757–1771

 Study funded by Institut Biochimique SA (IBSA), Switzerland.

 Dr. Baker has received research support from IBSA. Dr. Adamson is CEO and Shareholder of Advanced Reproductive Care, is a physician owner of Fertility Physicians of Northern California, has received research support from IBSA, and has been a speaker for Ferring Pharmaceuticals. His spouse is also a shareholder in Advanced Reproductive Care. Dr Hoehler has served as a consultant to IBSA, Vital Therapies, Inc., Pioneer Surgical, Kyphon, Cooper Surgical, and Fziomed. Dr. Jones is a consultant for VitalTherapies, Inc., and IBSA, and as of 7/1/07, became an employee of IBSA. Drs. Fujimoto, Kettel, and Soules report no conflicts of interest.

PII: S0015-0282(08)00159-3

doi: 10.1016/j.fertnstert.2008.01.064

Fertility and Sterility
Volume 91, Issue 4 , Pages 1005-1011 , April 2009

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