Follitropin alpha

OBJECTIVES: A redesigned pen injector for administration of follitropin alfa (follitropin α) has been developed for use in fertility treatment cycles. Pre-summative and summative usability testing was undertaken to assess the risk of dosing errors compared with the existing follitropin α pen. The study also assessed proper use of and dose selection with the redesigned pen. METHODS: Infertile women who were trying to conceive and specialist nurses were recruited from four cities in Germany...

INTRODUCTION: Treatment for infertility may require multiple drugs and complex dosing schedules. Available injection devices for patients who require regular injections during treatment are reviewed in this article, focusing on pen injectors used to self-administer recombinant human follicle-stimulating hormone (follitropin α). Following the introduction of the first and second follitropin α pen injectors in the last decade, a third pen injector with improved design for the administration of follitropin α has been developed for use in fertility treatment cycles...

CONDENSATION: Both Gonal-F and Puregon, especially in their high-dosage administration, might inhibit the endometrial cell proliferation in the initial 48-hour culture. After 72-hour culture, Gonal-F persisted the inhibition of the endometrial growth, whereas Puregon reversed its effect to enhance endometrial growth. OBJECTIVES: Endometrial proliferation or regeneration during menstrual cycle is regulated by sexual hormones. However, the effect of gonadotropins on the endometrial cell growth remains obscure...

Anovulation is a common cause of female subfertility. Treatment of anovulation is aimed at induction of ovulation. In women with clomiphene-citrate resistant WHO group II anovulation, one of the treatment options is ovulation induction with exogenous follicle-stimulating hormone (FSH or follitropin). FSH is derived from urine or is produced as recombinant FSH. Two forms of recombinant FSH are available - follitropin alpha and follitropin beta. To evaluate the efficacy, safety, costs and acceptability of recombinant FSH, we performed a review to compare recombinant FSH with urinary-derived FSH products...

BACKGROUND: Self-administration of recombinant human follicle-stimulating hormone (r-hFSH) can be performed using injection pen devices by women undergoing assisted reproductive technology procedures. The objective of this study was to explore the use of the prefilled follitropin alfa pen in routine assisted reproductive technology procedures in Germany. METHODS: This prospective, observational study was conducted across 43 German IVF centres over a period of 1...

Biological drugs represent an important and rapidly growing class of therapeutics useful in the treatment of a variety of disorders ranging from cancer to inflammation to infectious diseases. Unlike single chemical entities, the recombinant production of these drugs in living cells confers considerable structural and chemical heterogeneity to the biologically derived protein product that constitutes the active pharmaceutical ingredient (API). In mammalian based expression systems, much of this diversity is conferred through heterogeneous protein glycosylation...

The relationship between testosterone, vascular function, and blood pressure remains unclear. Here we utilized a mouse model of andropause, follitropin receptor knockout (FORKO) male mice, which are testosterone-deficient, to investigate whether vascular function and structure are altered and whether this is associated with elevated blood pressure. Blood pressure was measured by radiotelemetry, and vascular function and structure were assessed in isolated pressurized mesenteric resistance arteries in wild-type (WT) and FORKO mice...

Recombinant human follicle stimulating hormone (rFSH) and luteinizing hormone (LH), also known as follitropin alpha and lutropin alpha, are manufactured by genetic engineering techniques which ensure high quality and batch to batch consistency. Follitropin alpha can be used for controlled ovarian hyperstimulation in assisted reproduction, ovulation induction for WHO group I and II anovulatory infertility and in men with hypogonadotrophic hypogonadism (HH) or idiopathic oligo-asthenospermia. Current evidence suggests superiority of urinary human menopausal gonadotropin (HMG) over follitropin alpha in controlled ovarian hyperstimulation for IVF in terms of live birth rate per couple...

BACKGROUND: The development of new fertility treatment options has facilitated individualized assisted reproductive technology (ART) protocols to improve outcomes. Manufacturing improvements to recombinant human follitropin alfa have allowed precise dosing based on mass (filled-by-mass; FbM) rather than bioactivity (filled-by-bioassay; FbIU). Continued monitoring and reporting of follitropin alfa treatment outcomes in routine clinical practice is essential. OBJECTIVE: To provide an overview of the frequency of different controlled ovarian-stimulation protocols used in in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) cycles in new European Union member states, and to provide post-registration efficacy and safety data on follitropin alfa...

To identify baseline characteristics related to successful ovulation induction, data were analysed from oligo- or anovulatory patients undergoing their first cycle of human recombinant FSH (r-hFSH; follitropin alfa) in a chronic low-dose (75 IU starting dose), step-up protocol in two clinical trials (n=446). Patients were grouped according to response: group A, ovulated within 14 days (75 IU follitropin alfa); group B, ovulated after 14 days (>75 IU follitropin alfa); group C, not administered human chorionic gonadotrophin (HCG) because of poor response; group D, cycle cancelled due to over-response (HCG not administered); group E, spontaneous ovulation prior to obtaining criteria for administration of HCG...

PURPOSE: To determine if the addition of luteinizing hormone (LH) activity to a controlled ovarian hyperstimulation regimen for purposes of in vitro fertilization adds any additional benefit to the exclusive use of recombinant (r) FSH in antagonist protocols. METHODS: Women with normal endogenous gonadotropin levels were randomly assigned to receive either follitropin alpha exclusively or have the addition of 25 IU human chorionic gonadotropin (hCG) daily. Ganirelix was used when a 14 mm follicle was attained...

BACKGROUND: Over the last several decades, as a result of an evolution in manufacturing processes, a marked development has been made in the field of gonadotropins for ovarian stimulation. Initially, therapeutic gonadotropins were produced from a simple process of urine extraction and purification; now they are produced via a complex system involving recombinant technology, which yields gonadotropins with high levels of purity, quality, and consistency. METHODS: A retrospective analysis of 865 consecutive intracytoplasmic sperm injection (ICSI) cycles of controlled ovarian hyperstimulation (COH) compared the clinical efficacy of three gonadotropins (menotropin [hMG; n = 299], highly-purified hMG [HP-hMG; n = 330] and follitropin alfa [r-hFSH; n = 236]) for ovarian stimulation after pituitary down-regulation...

This prospective observational post-marketing survey aimed at studying the efficacy and convenience of the follitropin alpha filled-by-mass (FbM) pre-filled pen for patients in routine use. These data were analysed among 3196 non-selected treatment cycles and couples in seven Northern European countries. Valuable information was also obtained regarding the routine assisted reproduction treatment protocols used in Northern Europe. Out of 3196 cycles, human chorionic gonadotrophin (HCG) was administered in 3104 (97...

BACKGROUND: Human follicle-stimulating hormone (hFSH; follitropin alfa) can be employed therapeutically to induce ovarian follicular development in assisted reproduction treatments. Current recombinant hFSH (r-hFSH) preparations available for clinical use are labeled either in terms of the bioactivity expressed in international units (IU) or in mass (microg). Several clinical trials have tried to assess the clinical implications of the physicochemical improvements in the dosing of follitropin alfa filled by mass (FbM)...

OBJECTIVE: To assess the safety and efficacy of mixing cetrorelix with follitropin alfa (rFSH) in assisted reproductive technology. DESIGN: Prospective, randomized study. SETTING: An IVF center in a teaching hospital. PATIENT(S): One hundred forty patients undergoing intracytoplasmic sperm injection were randomized into mixed (M) or separate (S) injection groups. INTERVENTION(S): In the M group, rFSH and cetrorelix were mixed immediately before administration, whereas in the S group, rFSH and cetrorelix were administered separately...

OBJECTIVE: To investigate the efficacy, convenience and costs of recombinant follitropin alpha administered by a prefilled pen device and conventional syringe in Chinese women undergoing controlled ovarian stimulation for in vitro fertilization (IVF). METHODS: A total of 184 patients undergoing IVF treatment were enrolled in this study. According to a long-term recombinant follicle-stimulating hormone (rFSH) protocol, ovarian stimulation was performed with the prefilled pen and conventional syringe at random in these subjects, and the dose of follitropin, number of oocytes and embryo parameters and IVF-ET outcome were compared between the two groups...

The CONSORT dosing algorithm individualizes recombinant human FSH (r-hFSH) doses for assisted reproduction technologies, assigning 37.5 IU increments according to patient characteristics: basal FSH, body mass index, age and antral follicle count. A prospective, uncontrolled, international, 18-centre, pilot study of normo-ovulatory women aged 18-34 years inclusive undergoing a long agonist treatment protocol was performed. Follitropin alpha filled-by-mass (GONAL-f) dose was assigned by the algorithm and was intended to be altered only for risk of ovarian hyperstimulation syndrome (OHSS)...

Complete dissociation into subunits was attained by incubating Chinese hamster ovary (CHO)-derived or native human thyrotropin, follitropin and lutropin overnight at 37 degrees C in acetic acid. The alpha-and beta-subunits of the pituitary glycoprotein hormones were rapidly and quantitatively isolated by reversed-phase high-performance liquid chromatography (RP-HPLC). A dissociation efficiency of > 98% was obtained on the basis of mass determinations of the heterodimers and subunits carried out via mass spectrometry...

OBJECTIVE: To demonstrate the efficacy and safety of follitropin alfa administered with hCG on spermatogenesis in adult male hypogonadotropic hypogonadism (HH) patients. DESIGN: Phase III, multicenter, open-label, noncomparative. SETTING: Seven US medical centers. PATIENT(S): A total of 36 adult males with severe HH. INTERVENTION(S): A total of 1,000 U hCG on alternate days for 3 to 6 months, with dose adjustments after 2 months, if necessary, to normalize T levels, followed by follitropin alfa 150 U and hCG on the same alternate days for 18 months, with dose adjustments as necessary...

BACKGROUND: Rosacea fulminans is a rare and severe form of rosacea, with acute onset in women between 20 and 40 years. Although the aetiology remains unknown, pregnancy has been reported to be a triggering factor. We report a case of rosacea fulminans occurring at the onset of pregnancy and discuss a possible triggering role of endocrine factors, as well as therapeutic options. CASE REPORT: A 32-year-old woman with no previous history of dermatological disease consulted for rosacea fulminans appearing within the first three weeks of her first pregnancy, which required hormonal stimulation with recombinant FSH (follitropin alpha, Gonal F) and an LHRH inhibitor (cetrorelix, Cetrotide)...