Comparison of the efficacy and safety of a new recombinant human follicle-stimulating hormone (DA-3801) with follitropin-α (Gonal-F®) in women undergoing controlled ovarian hyperstimulation for assisted reproductive technology

Journal of Obstetrics and Gynaecology Research

Volumn 33, Issue 3, 2007, Pages 305-315

  Moon, Shin Yong ^a   Choi, Young Sik ^a   Ku, Seung Yup ^a   Kim, Seok Hyun ^a   Choi, Young Min ^a   Kang, Inn Soo ^b   Kim, Chung Hoon ^c  

^a Seoul National University   (South Korea)

^b Sungkyunkwan University School of Medicine   (South Korea)

^c University of Ulsan College of Medicine   (South Korea)

Author keywords

Assisted reproductive technology; Controlled ovarian hyperstimulation; DA 3801; Follitropin ; Recombinant human follicle stimulating hormone

Indexed keywords

CETRORELIX; CHORIONIC GONADOTROPIN; DA 3801; RECOMBINANT FOLLITROPIN; UNCLASSIFIED DRUG;

ADULT; ARTICLE; CLINICAL TRIAL; COMPARATIVE STUDY; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED OVARY HYPERSTIMULATION; CONTROLLED STUDY; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; ESTRADIOL BLOOD LEVEL; FEMALE; FERTILIZATION; FERTILIZATION IN VITRO; HUMAN; HUMAN CELL; INFERTILITY; INFERTILITY THERAPY; INTRACYTOPLASMIC SPERM INJECTION; LABORATORY TEST; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; MULTICENTER STUDY; NIDATION; OOCYTE; PHASE 3 CLINICAL TRIAL; PREGNANCY RATE; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL;

ADULT; CHORIONIC GONADOTROPIN; EMBRYO IMPLANTATION; ESTRADIOL; FEMALE; FERTILIZATION; FOLLICLE STIMULATING HORMONE, HUMAN; HUMANS; INFERTILITY, FEMALE; OVULATION INDUCTION; PREGNANCY; PREGNANCY OUTCOME; PREGNANCY RATE;

EID: 34250685627     PISSN: 13418076     EISSN: 14470756     Source Type: Journal    
DOI: 10.1111/j.1447-0756.2007.00529.x     Document Type: Article

References (26)

1. Olijve W, de Boer W, Mulders JW, van Wezenbeek PM. Molecular biology and biochemistry of human recombinant follicle stimulating hormone (Puregon). Mol Hum Reprod 1996 2 : 371 382.
2. Shoham Z, Insler V. Recombinant technique and gonadotropins production: new era in reproductive medicine. Fertil Steril 1996 66 : 187 201.
3. Matikainen T, De Leeuw R, Mannaerts B, Huhtaniemi I. Circulating bioactive and immunoreactive recombinant human follicle stimulating hormone (Org 32489) after administration to gonadotropin-deficient subjects. Fertil Steril 1994 61 : 62 69.
4. Dickey RP, Thornton M, Nichols J, Marshall DC, Fein SH, Nardi RV. Comparison of the efficacy and safety of a highly purified human follicle-stimulating hormone (Bravelle) and recombinant follitropin-beta for in vitro fertilization: a prospective, randomized study. Fertil Steril 2002 77 : 1202 1208.
5. 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.
6. Out HJ, Mannaerts BM, Driessen SG, Bennink HJ. A prospective, randomized, assessor-blind, multicentre study comparing recombinant and urinary follicle stimulating hormone (Puregon versus Metrodin) in in-vitro fertilization. Hum Reprod 1995 10 : 2534 2540.
7. Bergh C, Howles CM, Borg K et al. Recombinant human follicle stimulating hormone (r-hFSH; Gonal-F) versus highly purified urinary FSH (Metrodin HP): results of a randomized comparative study in women undergoing assisted reproductive techniques. Hum Reprod 1997 12 : 2133 2139.
8. Daya S, Gunby J. Recombinant versus urinary follicle stimulating hormone for ovarian stimulation in assisted reproduction. Hum Reprod 1999 14 : 2207 2215.
9. Frydman R, Howles CM, Truong F. A double-blind, randomized study to compare recombinant human follicle stimulating hormone (FSH; Gonal-F) with highly purified urinary FSH (Metrodin HP) in women undergoing assisted reproductive techniques including intracytoplasmic sperm injection. The French Multicentre Trialists. Hum Reprod 2000 15 : 520 525.
10. Schats R, Sutter PD, Bassil S, Kremer JA, Tournaye H, Donnez J. Ovarian stimulation during assisted reproduction treatment: a comparison of recombinant and highly purified urinary human FSH. On behalf of The Feronia and Apis Study Group. Hum Reprod 2000 15 : 1691 1697.
11. Strehler E, Abt M, El-Danasouri I, De Santo M, Sterzik K. Impact of recombinant follicle-stimulating hormone and human menopausal gonadotropins on in vitro fertilization outcome. Fertil Steril 2001 75 : 332 336.
12. Westergaard LG, Erb K, Laursen SB, Rex S, Rasmussen PE. Human menopausal gonadotropin versus recombinant follicle-stimulating hormone in normogonadotropic women down-regulated with a gonadotropin-releasing hormone agonist who were undergoing in vitro fertilization and intracytoplasmic sperm injection: a prospective randomized study. Fertil Steril 2001 76 : 543 549.
13. van Wely M, Westergaard LG, Bossuyt PM, 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.
14. Howles CM. Genetic engineering of human FSH (Gonal-F). Hum Reprod Update 1996 2 : 172 191.
15. de Leeuw R, Mulders J, Voortman G, Rombout F, Damm J, Kloosterboer L. Structure-function relationship of recombinant follicle stimulating hormone (Puregon). Mol Hum Reprod 1996 2 : 361 369.
16. Tulppala M, Aho M, Tuuri T et al. Comparison of two recombinant follicle-stimulating hormone preparations in in-vitro fertilization: a randomized clinical study. Hum Reprod 1999 14 : 2709 2715.
17. Harlin J, Csemiczky G, Wramsby H, Fried G. Recombinant follicle stimulating hormone in in-vitro fertilization treatment-clinical experience with follitropin alpha and follitropin beta. Hum Reprod 2000 15 : 239 244.
18. Chappel SC. Heterogeneity of follicle stimulating hormone: control and physiological function. Hum Reprod Update 1995 1 : 479 487.
19. Blum WF, Riegelbauer G, Gupta D. Heterogeneity of rat FSH by chromatofocusing: studies on in-vitro bioactivity of pituitary FSH forms and effect of neuraminidase treatment. J Endocrinol 1985 105 : 17 27.
20. Mulders JW, Derksen M, Swolfs A, Maris F. Prediction of the in vivo biological activity of human recombinant follicle stimulating hormone using quantitative isoelectric focusing. Biologicals 1997 25 : 269 281.
21. Horsman G, Talbot JA, McLoughlin JD, Lambert A, Robertson WR. A biological, immunological and physico-chemical comparison of the current clinical batches of the recombinant FSH preparations Gonal-F and Puregon. Hum Reprod 2000 15 : 1898 1902.
22. Koh SB, Seo KS, Kim SC, Ahn BO, Kim WB, Lee SH. Effect of recombinant human FSH on ovulation, pregnancy and in vitro fertilization in androgen-sterilized mice. Arch Pharm Res 2002 25 : 357 363.
23. Arce JC, Nyboe Andersen A, 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.
24. European and Israeli Study Group on Highly Purified Menotropin versus Recombinant Follicle-Stimulating Hormone. Efficacy and safety of highly purified menotropin versus recombinant follicle-stimulating hormone in in vitro fertilization/intracytoplasmic sperm injection cycles: a randomized, comparative trial. Fertil Steril 2002 78 : 520 528.
25. Latin-American Puregon IVF Study Group. A double-blind clinical trial comparing a fixed daily dose of 150 and 250 IU of recombinant follicle-stimulating hormone in women undergoing in vitro fertilization. Fertil Steril 2001 76 : 950 956.
26. Yong PY, Brett S, Baird DT, Thong KJ. A prospective randomized clinical trial comparing 150 IU and 225 IU of recombinant follicle-stimulating hormone (Gonal-F®) in a fixed-dose regimen for controlled ovarian stimulation in in vitro fertilization treatment. Fertil Steril 2003 79 : 308 315.