Safety and efficacy of Ovaleap® (recombinant human follicle-stimulating hormone) for up to 3 cycles in infertile women using assisted reproductive technology: A phase 3 open-label follow-up to Main Study

Reproductive Biology and Endocrinology

Volumn 14, Issue 1, 2016, Pages

  Strowitzki, Thomas ^a   Kuczynski, Waldemar ^b,c   Mueller, Arnd ^d   Bias, Peter ^d  

^a UNIVERSITY OF HEIDELBERG   (Germany)

^b Centre for Reproductive Medicine   (Poland)

^c MEDICAL UNIVERSITY OF BIALYSTOK   (Poland)

^d TEVA PHARMACEUTICALS   (Israel)

Author keywords

Assisted reproductive technology (ART); Follitropin alfa; Infertility; Ovaleap; R hFSH

Indexed keywords

DRUG ANTIBODY; RECOMBINANT FOLLITROPIN; FOLLITROPIN; RECOMBINANT PROTEIN;

ADULT; ANEMIA; APPENDICITIS; APPLICATION SITE ERYTHEMA; APPLICATION SITE PRURITUS; ARTICLE; BACKACHE; CONTROLLED STUDY; CYST; DEPRESSION; DRUG DELIVERY DEVICE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FEMALE INFERTILITY; FEVER; FLU LIKE SYNDROME; FOLLOW UP; HEMATOMA; HUMAN; IMMUNOGENICITY; INFERTILITY THERAPY; INJECTION PEN; INJECTION SITE ERYTHEMA; INJECTION SITE PRURITUS; LOWER ABDOMINAL PAIN; MAJOR CLINICAL STUDY; MENORRHAGIA; METRORRHAGIA; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MUSCLE SPASM; NAUSEA; OOCYTE RETRIEVAL; OUTCOME ASSESSMENT; OVARY HYPERSTIMULATION; OVARY TUMOR; PAIN; PATIENT SATISFACTION; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT INFLAMMATION; SINUSITIS; UPPER RESPIRATORY TRACT INFECTION; VAGINA DISCHARGE; VAGINITIS; VULVOVAGINAL DISEASE; CHEMICALLY INDUCED; CLINICAL TRIAL; INFERTILITY, FEMALE; OVULATION INDUCTION; PREGNANCY; PREGNANCY RATE; PROCEDURES;

ADULT; FEMALE; FOLLICLE STIMULATING HORMONE; FOLLICLE STIMULATING HORMONE, HUMAN; FOLLOW-UP STUDIES; HUMANS; INFERTILITY, FEMALE; OVARIAN HYPERSTIMULATION SYNDROME; OVULATION INDUCTION; PATIENT SATISFACTION; PREGNANCY; PREGNANCY RATE; RECOMBINANT PROTEINS;

EID: 84976884442     PISSN: None     EISSN: 14777827     Source Type: Journal    
DOI: 10.1186/s12958-016-0164-y     Document Type: Article

References (26)

1. Daya S. Follicle-stimulating hormone in clinical practice: an update. Treat Endocrinol. 2004;3:161-71.
2. van Wely M, Kwan I, Burt AL, et al. Recombinant versus urinary gonadotrophin for ovarian stimulation in assisted reproductive technology cycles. Cochrane Database Syst Rev. 2011;(2):CD005354.
3. Harrison S, Wolf T, Abuzeid MI. Administration of recombinant follicle stimulating hormone in a woman with allergic reaction to menotropin: a case report. Gynecol Endocrinol. 2000;14:149-52.
4. European Medicines Agency (EMA). Ovaleap (follitropin alfa) [assessment report]. London, UK: EMA; July 31, 2013. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002608/WC500152908.pdf (2013). Accessed 10 Mar 2016.
5. Weise M, Bielsky MC, De Smet K, et al. Biosimilars-why terminology matters. Nat Biotechnol. 2011;29:690-3.
6. Committee for Medicinal Products for Human Use (CHMP). Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human follicle stimulating hormone (r-hFSH). London: EMA; 2011.
7. Lammerich A, Mueller A, Bias P. Phase I, two-way, crossover study to demonstrate bioequivalence and to compare safety and tolerability of single-dose XM17 vs Gonal-f® in healthy women after follicle-stimulating hormone downregulation. Reprod Biol Endocrinol. 2015;13:130.
8. Lammerich A, Bias P, Gertz B. Phase 1 safety, tolerability, and pharmacokinetic study of single ascending doses of XM17 (recombinant human follicle-stimulating hormone) in downregulated healthy women. Int J Women's Health. 2015;7:707-16.
9. Strowitzki T, Kuczynski W, Mueller A, Bias P. Randomized, active-controlled, comparative phase 3 efficacy and safety equivalence trial of Ovaleap® (recombinant human follicle-stimulating hormone) in infertile women using assisted reproduction technology (ART). Reprod Biol Endocrinol. 2016;14:1.
10. Scott L, Alvero R, Leondires M, Miller B. The morphology of human pronuclear embryos is positively related to blastocyst development and implantation. Hum Reprod. 2000;15:2394-403.
11. Papanikolaou EG, Pozzobon C, Kolibianakis EM, et al. Incidence and prediction of ovarian hyperstimulation syndrome in women undergoing gonadotropin-releasing hormone antagonist in vitro fertilization cycles. Fertil Steril. 2006;85:112-20.
12. Navot D, Bergh PA, Laufer N. Ovarian hyperstimulation syndrome in novel reproductive technologies: prevention and treatment. Fertil Steril. 1992;58:249-61.
13. Somkuti SG, Schertz JC, Moore M, Ferrande L, Kelly E. Patient experience with follitropin alfa prefilled pen versus previously used injectable gonadotropins for ovulation induction in oligoanovulatory women. Curr Med Res Opin. 2006;22:1981-96.
14. Zou L, Mueller A, Gertz G, Weiss H, Liu P. Immunogenicity assessment of Ovaleap® (XM17) recombinant human follicle-stimulating hormone in infertile women undergoing assisted reproductive technology (ART). Presented at the 17th World Congress of Gynecological Endocrinology, March 2-5, 2016, Florence, Italy
15. 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;78:520-8.
16. 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;76:543-9.
17. 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. Hum Reprod. 2000;15:520-5.
18. 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. Hum Reprod. 2000;15:1691-7.
19. Andersen AN, Devroey P, Arce JC. Clinical outcome following stimulation with highly purified hMG or recombinant FSH in patients undergoing IVF: a randomized assessor-blind controlled trial. Hum Reprod. 2006;21:3217-27.
20. Imthurn B, Rettenbacher M, Bemfola Study Group. A phase III assessor-blinded randomised multi-centre study to compare efficacy and safety of two r-hFSH formulations (AFOLIA [Bemfola®] vs Gonal-f®) in women for assisted reproductive treatment [abstract]. Hum Reprod. 2013;28 suppl 1:i45.
21. Utsunomiya T, Tanaka A, Tatsumi K, Ezcurra D. A questionnaire-based survey to assess patient satisfaction, ease-of-learning, ease-of-use, injection site pain and overall patient satisfaction of the follitropin-alpha (Gonal-f) filled-by-mass (FbM) prefilled pen compared with other systems of gonadotrophin administration. Reprod Biol Endocrinol. 2012;10:93.
22. Welcker JT, Nawroth F, Bilger W. Patient evaluation of the use of follitropin alfa in a prefilled ready-to-use injection pen in assisted reproductive technology: an observational study. Reprod Biol Endocrinol. 2010;8:111.
23. Rabinson J, Ashkenazi J, Homburg R, Meltcer S, Anteby EY, Orvieto R. Repeated in vitro fertilization cycle attempts in patients undergoing controlled ovarian hyperstimulation with use of gonadotropin-releasing hormone antagonists. Fertil Steril. 2009;91:1473-5.
24. Eppsteiner EE, Sparks AE, Liu D, Van Voorhis BJ. Change in oocyte yield in repeated in vitro fertilization cycles: effect of ovarian reserve. Fertil Steril. 2014;101:399-402.
25. Landfeldt E, Jablonowska B, Norlander E, et al. Patient preferences for characteristics differentiating ovarian stimulation treatments. Hum Reprod. 2012;27:760-9.
26. Boivin J, Domar AD, Shapiro DB, Wischmann TH, Fauser BC, Verhaak C. Tackling burden in ART: an integrated approach for medical staff. Hum Reprod. 2012;27:941-50.