Ovulatory dysfunction, which is common among women of reproductive age, often results in infertility. Over the last three decades, follicle-stimulating hormone (FSH), in the form of either urinary human menopausal gonadotropin or highly purified urinary FSH (uFSH), has been the mainstay in the treatment of women with ovulatory dysfunction. However, these preparations have several disadvantages, including variable composition, contamination with urinary proteins, and the limited availability of human menopausal urine from which uFSH is extracted. Recombinant human FSH (rhFSH) demonstrates higher purity and specific activity, and is suitable for subcutaneous administration. Additionally, rhFSH has facilitated the development of additional FSH products such as FSH-carboxy terminal peptide that possess different pharmacokinetic and pharmacodynamic properties and may provide more options in the treatment of ovulatory dysfunction and infertility. This article reviews the mechanism of action of FSH in folliculogenesis and ovulation, the current use of FSH in women for the medical management of infertility, and the published clinical experience to date with different rhFSH preparations.Infertility affects more than 6 million couples in the USA, or approximately 10 to 15% of couples in the reproductive population, with 30-40% of female infertility due to anovulatory disorders [1]. The current medical management of infertility frequently involves the use of gonadotropins in women.Gonadotropin hormones play a central role in the regulation of follicular development and ovulation. Inadequate levels of the gonadotropin, follicle-stimulating hormone (FSH), can result in the absence of ovulation.Urinary-derived preparations of FSH (uFSH) are extracted from the urine of menopausal women. They have been used successfully to induce ovulation in anovulatory women (World Health Organization [WHO] groups I and II) and to stimulate multifollicular development during ovarian stimulation regimens for in vitro fertilization (IVF) [2]. Although effective, uFSH has several disadvantages, including variable composition, contamination with urinary proteins, and limited supply of raw materials for purification [2,3]. Advances in purification techniques have resulted in the production of highly purified uFSH, which contains over 95% FSH. The introduction of recombinant human FSH (rhFSH) in the early 1990s has overcome some of the limitations of urinary-derived preparations. Recombinant human FSH demonstrates high potency, uniform composition, and high specific activity [4][5][6][7].This article reviews the mechanism of action of FSH in folliculogenesis and ovulation, the current use of FSH in women for the medical management of infertility, and published clinical experience to date with the use of different FSH preparations in women. Recent findings of studies evaluating the use of a pen device for selfadministration of rhFSH and novel long-lasting rhFSH agonists are also discussed.
Role of FSH in folliculogenesisHuman FSH is composed of a fa...