An Observational Study of Follitropin Alpha Biosimilar: the Real-world Data
Condition: Reproductive Issues; Reproductive Disorder; Fertility Disorders; Fertility Issues; Gynecologic Disease; IVF
MeSH terms: Genital Diseases, Female; Infertility
Study type: Observational

Summary: 
      Aim to investigate the efficacy of follitropin alpha biosimilar therapy (Primapur®) in
      nonselected real-world population.
    

Detailed description: 
      A retrospective observational anonymized cohort study of follitropin alpha biosimilar
      (Primapur®) as a pre-filled pen injector with a dose adjustment of 5 IU, aimed to investigate
      its efficacy and safety in a nonselected population with indications to assisted reproductive
      technologies (ART) was carried out. The ovarian stimulation (OS) protocols included:

      monotherapy protocols with using only Primapur®; mixed protocols (recombinant and
      urinary-derived gonadotropins); short protocols with using antagonists of
      gonadotropin-releasing hormone (GnRH) and long protocols with GnRH agonists. The stimulation
      protocols were analyzed with Primapur® application for at least 5 days.
    

Intervention name(s): Follitropin Alfa; Follicle Stimulating Hormone/Luteinizing Hormone; Follitropin Alfa; Follitropin Alfa; Follicle Stimulating Hormone/Luteinizing Hormone
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using antagonists of GnRH or agonist of GnRH.; Subcutaneous injection of follitropin alpha biosimilar, with daily dose 100-300 IU for at least 5 days, than added another gonadotropin for a maximum of 10 days, using antagonists of GnRH or agonist of GnRH.; Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using antagonists of GnRH only for suppression.; Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using agonists of GnRH only for suppression.; Overall ovarian stimulation protocols with follitropin alpha biosimilar for at least 5 days+other recombinant and menotropins and short (antagonists of GnRH) or long protocol (agonist of GnRH).
Other intervention name(s): Primapur; Biosimilar; Follitropin beta; Follitropin alfa + Lutropin alfa; Corifollitropin alfa; Menotropins; Follitropin alfa; Follitropin alfa biosimilar; Primapur; Biosimilar; Follitropin alfa biosimilar; Primapur; Biosimilar; Follitropin alfa biosimilar; Follitropin beta; Corifollitropin alfa; Follitropin alfa + Lutropin alfa; Menotropins; Follitropin alfa biosimilar; Follitropin alfa
Intervention MeSH terms: Menotropins; Hormones; Follicle Stimulating Hormone
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women aged 20-43 with established causes of infertility and indications for the use of
        assisted reproductive technologies (ART) and ovarian stimulation with follitropin alpha.
      
Keywords: follitropin alpha; follicle-stimulating hormone; in vitro fertilization; assisted reproductive technologies; biosimilar; follitropin alfa; real-world data