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)
| Autor: | Arnd Mueller, Peter Bias, Thomas Strowitzki, Waldemar Kuczyński |
|---|---|
| Jazyk: | angličtina |
| Předmět: |
Adult
0301 basic medicine medicine.medical_specialty Follitropin alfa Pregnancy Rate medicine.medical_treatment Population Oocyte Retrieval law.invention 03 medical and health sciences Follicle-stimulating hormone 610 Medical sciences Medicine 0302 clinical medicine Endocrinology Gonal-f Ovulation Induction Randomized controlled trial Assisted reproductive technology (ART) Pregnancy law Follicular phase medicine Humans Single-Blind Method education Gynecology education.field_of_study 030219 obstetrics & reproductive medicine Assisted reproductive technology business.industry Research Pregnancy Outcome Obstetrics and Gynecology Recombinant Proteins Pregnancy rate 030104 developmental biology Tolerability Equivalence Trial Reproductive Medicine Patient Satisfaction Infertility Oocytes Regression Analysis Female Follicle Stimulating Hormone Human Ovaleap business Developmental Biology |
| Zdroj: | Reproductive Biology and Endocrinology : RB&E |
| ISSN: | 1477-7827 |
| DOI: | 10.1186/s12958-015-0135-8 |
| Popis: | Background: Pharmacokinetic studies with XM17 (Ovaleap®), a recombinant human follicle-stimulating hormone (r-hFSH, follitropin alfa), have demonstrated good safety and tolerability in healthy women whose endogenous FSH levels were down-regulated with a long agonist protocol. In these studies, Ovaleap® pharmacokinetics were dose-proportional and bioequivalent to the reference follitropin alfa product (Gonal-f®). The objective of the present study is to determine whether Ovaleap® is equivalent to Gonal-f® with respect to the number of oocytes retrieved in infertile but ovulatory women undergoing assisted reproductive technology (ART) therapy. Methods: This multinational, multicenter, randomized (1:1), active-controlled, assessor-blind, comparative study included infertile normally gonadotrophic women 18 to 37 years old with a body mass index of 18 to 29 kg/m2 and regular menstrual cycles of 21 to 35 days undergoing ART therapy. During a 5-day fixed-dose phase, women received 150 IU/day of Ovaleap® (n = 153) or Gonal-f® (n = 146), followed by an up to 15-day dose-adaptation phase during which doses could be adjusted every 3 to 5 days, up to a maximum of 450 IU/day. Ovaleap® was to be deemed equivalent to Gonal-f® if the two-sided 0.95 confidence interval (CI) for the difference in the number of oocytes retrieved fell within the equivalence range of ±3 oocytes. Results: Similar numbers of oocytes were retrieved in the 2 treatment groups. The mean ± SD number of oocytes retrieved was 12.2 ± 6.7 in the Ovaleap® group and 12.1 ± 6.7 in the Gonal-f® group (intent-to-treat [ITT] population). Regression analysis estimated a mean difference of 0.03 oocytes between the treatment groups (95 % CI: −0.76-0.82), which was well within the prespecified equivalence range of ±3 oocytes. Ovaleap® and Gonal-f® showed favorable and comparable safety profiles, with no unexpected safety findings. Conclusions: Ovaleap® has shown the same efficacy and safety as Gonal-f® for stimulation of follicular development in infertile women (up to 37 years of age) who are undergoing ART therapy. Trial Registration EudraCT: 2009-017674-20. Current controlled trials: ISRCTN74772901. Date of trial registration: 19 March 2010. |
| Databáze: | OpenAIRE |
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