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Follitropin alpha

Leonardo Rinaldi, Helmy Selman
A severe gonadotropin deficiency together with chronic estradiol deficiency leading to amenorrhea characterizes patients suffering from hypogonadotropic hypogonadism. Administration of both follicle-stimulating hormone (FSH) and luteinizing hormone (LH) to these patients has been shown to be essential in achieving successful stimulation of follicular development, ovulation, and rescue of fertility. In recent years, the availability of both recombinant FSH (rFSH) and recombinant LH (rLH) has provided a new therapeutic option for the stimulation of follicular growth in hypopituitary-hypogonadotropic women (World Health Organization Group I)...
2016: International Journal of Women's Health
Raoul Orvieto, David B Seifer
As patents expire on innovator products, there is increasing interest in developing biosimilar products globally. Biosimilars are not exact copies and are not considered generic versions of the reference product. They may differ in strength, purity and contain different composition of isoforms and/or various glycosylation profiles, with the consequent alterations in clinical efficacy or safety. Recently 2 new recombinant FSH preparations were introduced to clinical practice following randomized controlled, phase 3 clinical trials...
June 14, 2016: Reproductive Biology and Endocrinology: RB&E
I Lindgren, M Bååth, K Uvebrant, A Dejmek, L Kjaer, E Henic, M Bungum, L Bungum, C Cilio, I Leijonhufvud, S Skouby, C Yding Andersen, Y Lundberg Giwercman
STUDY QUESTION: Can gonadotrophin receptor variants separately or in combination, be used for the prediction of pregnancy chances in in vitro fertilization (IVF) trials? SUMMARY ANSWER: The luteinizing hormone/human chorionic gonadotrophin receptor (LHCGR) variant N312S and the follicle-stimulating hormone receptor (FSHR) variant N680S can be utilized for the prediction of pregnancy chances in women undergoing IVF. WHAT IS KNOWN ALREADY: The FSHR N680S polymorphism has been shown to affect the ovarian response in response to gonadotrophin treatment, while no information is currently available regarding variants of the LHCGR in this context...
March 2016: Human Reproduction
E Iu Zagarskikh, A V Labygina, N A Kurashova
This study presents an experience of application of follicle-stimulating drug in the treatment of men with normogonadotropic infertility. Patients of the study group have received standard treatment, including multivitamins, and additionally received follitropin-alpha (Gonal-f). They also underwent ultraviolet blood irradiation. Patients of comparison group were treated according to a standard scheme. All men underwent standard clinical and laboratory examination. The therapy consisting of follitropin alpha and ultraviolet blood irradiation in patients with infertility normalizes the function of endocrine glands, as indicated by an increase of testosterone levels, and decrease of prolactin and FSH levels...
September 2014: Urologii︠a︡
S Sahmay, T A Usta, G Zebitay, L M Senturk, E Oral, P Ocal, M Idil, T Irez
AIM: The aim of this study was to compare human menopausal gonadotropins with recombinant follicle stimulating hormone-follitropin alpha following a long down-regulation protocol in intra cytoplasmic sperm injection cycles in our clinic, and to review the outcomes in the light of preceding studies. METHODS: This was a retrospective study. Among a total number of 2798 patients who had undergone IVF/ICSI applications, 579 eligible patients were included, and their data were evaluated retrospectively...
August 2014: Minerva Ginecologica
Klaus Bühler, Olaf G J Naether, Wilma Bilger
BACKGROUND: Follicle-stimulating hormone (FSH) and luteinizing hormone (LH) both have a role to play in follicular development during the natural menstrual cycle. LH supplementation during controlled ovarian stimulation (COS) for assisted reproductive technology (ART) is used for patients with hypogonadotropic hypogonadism. However, the use of exogenous LH in COS in normogonadotropic women undergoing ART is the subject of debate. The aim of this study was to investigate characteristics of infertile women who received the 2:1 formulation of follitropin alfa and lutropin alfa (indicated for stimulation of follicular development in women with severe LH and FSH deficiency) in German clinical practice...
January 14, 2014: Reproductive Biology and Endocrinology: RB&E
Xiuyan Feng, Meilin Zhang, Rongbin Guan, Deborah L Segaloff
The LH receptor (LHR) and FSH receptor (FSHR) are each G protein-coupled receptors that play critical roles in reproductive endocrinology. Each of these receptors has previously been shown to self-associate into homodimers and oligomers shortly after their biosynthesis. As shown herein using bioluminescence resonance energy transfer to detect protein-protein interactions, our data show that the LHR and FSHR, when coexpressed in the same cells, specifically heterodimerize with each other. Further experiments confirm that at least a portion of the cellular LHR/FSHR heterodimers are present on the cell surface and are functional...
October 2013: Endocrinology
Takafumi Utsunomiya, Atsushi Tanaka, Kenichi Tatsumi, Diego Ezcurra
BACKGROUND: Gonadotrophins are used routinely for follicular stimulation during ovarian induction and assisted reproduction techniques. Developments in recombinant follicle-stimulating hormone preparations and their injection devices have improved patient quality of life by enabling patients to self-administer treatment at home. The objective of this study was to investigate patient experiences of learning to use and overall satisfaction with the follitropin-alpha (Gonal-f) filled-by-mass (FbM) prefilled pen...
2012: Reproductive Biology and Endocrinology: RB&E
Miriam Heredia, José María Tenías, María Sanchez, Maria Dolores Fraga, Miguel Angel Calleja, Juan Carlos Valenzuela
A longitudinal, observational prospective panel cohort study of 61 patients lasting one year was undertaken. Explanatory variables included sociodemographic factors along with factors related to the underlying pathology as well as the protocol used and the type of treatment received. These variables were analyzed both individually and in combination to account for confounding effects and model interactions. A generalized estimating equation (GEE) model was constructed for each adverse effect. Associations were calculated as odds ratios (OR)...
October 2012: Systems Biology in Reproductive Medicine
Joan C Schertz, Helen Saunders, Clara Hecker, Barbara Lang, Pablo Arriagada
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...
September 2011: Expert Opinion on Drug Delivery
Michel Christen, Joan C Schertz, Pablo Arriagada, Joachim Keitel, Heiko Müller
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...
June 2011: Expert Opinion on Drug Delivery
Chi-Chen Chang, Yao-Yuan Hsieh, Kung-Hao Hsu, Chih-Sheng Lin
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...
March 2011: Taiwanese Journal of Obstetrics & Gynecology
Marleen Nahuis, Fulco van der Veen, Jur Oosterhuis, Ben Willem Mol, Peter Hompes, Madelon van Wely
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...
2010: International Journal of Women's Health
J Thomas Welcker, Frank Nawroth, Wilma Bilger
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...
2010: Reproductive Biology and Endocrinology: RB&E
Cuihua Liu, Shiming Dong, Xiao-Jin Xu, Yan Yin, Zachary Shriver, Ishan Capila, James Myette, Ganesh Venkataraman
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...
January 5, 2011: Journal of Pharmaceutical and Biomedical Analysis
Danesh Javeshghani, M Ram Sairam, Ernesto L Schiffrin, Rhian M Touyz
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...
September 2007: Journal of the American Society of Hypertension: JASH
Ahmed Gibreel, Siladitya Bhattacharya
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...
February 4, 2010: Biologics: Targets & Therapy
Veljko Vlaisavljević, Helena Meden-Vrtovec, Piotr Lewandowski, Michał Radwan, Alena Langerova, Milan Vicena, Jozef Války, Miroslav Herman, Audronë Usoniene, Gints Treijs
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...
April 2010: Current Medical Research and Opinion
C M Howles, V Alam, D Tredway, R Homburg, D W Warne
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...
February 2010: Reproductive Biomedicine Online
J H Check, E Davies, D Brasile, J K Choe, J Amui
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...
2009: Clinical and Experimental Obstetrics & Gynecology
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