Urinary Follicle Stimulating Hormone Preparations Research Articles

Effects of highly purified urinary FSH and human menopausal FSH on uterine myoelectrical dynamics

The aim of the study was to investigate the effects of urinary follicle-stimulating hormone (FSH) compounds on the electrical activity of myometrium using signal-processing techniques. Thirty animals were involved in the experiment. After two successive normal estrous cycles, 15 of these animals were put into three equal subgroups. Group 1 was the control; animals were given solvent. Groups 2 and 3 were treated with Urofollitropin and Menotropin, respectively. The other 15 animals were ovariectomized and subjected to the same protocol. Their uterine myoelectrical signals were recorded over a period of at least 3 min at a sampling frequency of 500 Hz, and analyzed through software assisted signal processing. The results show the power and some characteristic spectral components of myoelectrical signal were differentially reduced with the administration of highly purified urinary FSH and human menopausal FSH but significant differences were not detected between their histology. In conclusion, uterine myoelectrical signals change with administration of urinary FSH preparations. Human menopausal FSH and more precisely highly purified FSH suppress the spectral components and modify the power of the myoelectrical signals which provides uterine quiescence.

Role of LH and FSH in ovarian function

Human gonadotrophin preparations have been used in the treatment of infertility for almost four decades. The earliest preparations were derived from urine from postmenopausal women and contained approximately equal amounts of follicle stimulating hormone (FSH) and luteinizing hormone (LH) activities. However, with the recognition that FSH is the principal regulator of follicular growth and maturation, these have been largely superseded by highly purified urinary FSH preparations and, more recently, recombinant human FSH (r-hFSH). Because of its complexity, r-hFSH is expressed in mammalian cells grown in culture and, from a manufacturing stand point, offers superior purity and batch-to-batch consistency, compared with urinary preparations. A number of clinical trials have compared the efficacy of r-hFSH and urinary FSH in women undergoing assisted reproductive technologies (ART). In general, these have shown that fewer FSH ampoules are required to achieve ovarian stimulation with r-hFSH, while the number of oocytes retrieved and embryos produced are higher than with urinary FSH. Additionally, the results of a recent meta-analysis have also shown that the clinical pregnancy rate per cycle started is significantly higher with r-hFSH, compared with urinary FSH. Furthermore, in poor responder patients, higher implantation rates were seen in patients treated with r-hFSH than in those treated with urinary FSH, suggesting that embryo viability is increased following use of the recombinant preparations. The finding that FSH preparations produce effective ovarian stimulation compared to human menopausal gonadotrophins in women undergoing ART raises the question of whether LH is required for ovarian stimulation. This has been investigated in a number of recent studies. For example, results have suggested that implantation rates may actually be lower in women who received exogenous LH. Such studies suggest, therefore, that in normogonadotrophic women, the addition of LH to an r-hFSH regimen does not add any further clinical benefit and may actually be detrimental. Hence, it appears that LH administration is necessary only in women with hypogonadotrophic hypogonadism. In conclusion, r-hFSH is a consistently pure and high quality gonadotrophin preparation and contributes to increasing the successful outcome of an ART cycle. Together with careful auditing of routine clinical practice, and the application of evidence-based medicine to facilitate clinical decision making, this means that a total quality management approach can be applied to optimize the outcome of assisted reproduction.

A prospective, randomized, controlled clinical study of a new subcutaneous, purified, urinary FSH preparation for controlled ovarian hyperstimulation in in vitro fertilization

The aim of this study was to evaluate the clinical efficacy and safety of a new urinary follicle stimulating hormone (FSH) preparation (Fostimon®) in patients undergoing in vitro fertilization–embryo transfer or intracytoplasmic sperm injection. Metrodin HP® was adopted as a reference drug, as its purity and therapeutic efficacy are well known. Sixty normo-ovulatory patients aged 18–38 years with normal basal FSH and body mass index < 25 kg/m2 were selected for the study. After gonadotropin releasing hormone analogue pituitary desensitization, patients were randomized to receive either Fostimon or Metrodin HP at the initial dosage of 225 IU for 6 days. Thereafter, the dosage was tailored according to the ovarian response. Both drugs were administered by the subcutaneous route. The primary end-points were: number of follicles larger than 15 mm, levels of 17β-estradiol on the day of human chorionic gonadotropin (hCG) injection and number of oocytes recovered. The secondary end-points were: number of FSH ampules used, day of hCG injection and pregnancy rate. FSH kinetic curves were calculated during the treatment period with both products. Safety was evaluated by pre- and post-treatment blood biochemistry and hematology, and recording all side-effects. Local tolerance was investigated at each visit. None of the parameters evaluated showed a statistically significant difference between the two groups. Local tolerance was always recorded as good/excellent by both the patients and the physician. In conclusion, Fostimon proved to be an effective and safe drug for assisted reproductive cycles.

Allergic reaction to a highly purified urinary follicle stimulating hormone preparation in controlled ovarian hyperstimulation for in vitro fertilization

We report a case of general hypersensitivity-like allergic reactions to intramuscular injections of highly purified urinary follicle stimulating hormone (uFSH-HP) successfully managed by using intramuscular recombinant FSH (rFSH).The patient underwent a first cycle of in vitro fertilization (IVF) and controlled ovarian hyperstimulation (COH) was achieved with a combination of gonadotropin releasing hormone against (GnRH-a) and uFSH-HP. Because, after oocyte recovery, no fertilization occurred, the couple subsequently entered an intracytoplasmic sperm injection (ICSI) program. During the COH, the woman developed general hypersensitivity-like allergic reactions with itching, redness and swelling. Although there was regular follicular growth, the allergic symptoms worsened and, on day 8 of COH, the stimulation cycle was suspended. A few months later, the patient entered a new ICSI cycle. COH was achieved by using a combination of GnRH-a and rFSH. The cycle was completed and the patient did not report any allergic reaction.To avoid allergic reaction to the protein components of the urine-derived FSH preparations, the use of rFSH is suggested in those patients who present local and/or general hypersensitivity-like allergic reactions.

O-230. Comparison of recombinant and urinary follicle stimulating hormone preparations efficiency for achievement of follicular selection in patients with chronic anovulation (World Health Organization group II)

O-230. Comparison of recombinant and urinary follicle stimulating hormone preparations efficiency for achievement of follicular selection in patients with chronic anovulation (World Health Organization group II)

A bioequivalence study of two urinary follicle stimulating hormone preparations: Follegon and Metrodin

The purpose of this study was to demonstrate bioequivalence between two follicle stimulating hormone (FSH)-only gonadotrophin preparations (Follegon(R) and Metrodin(R)) after a single i.m. injection of IU FSH in-vivo bioactivity. A total of 16 healthy normally cycling females were treated for 7 weeks with a high-dose oral contraceptive containing 50 microg ethinyl oestradiol plus 2.5 mg lynestrenol (Lyndiol(R)) to suppress endogenous gonadotrophin production. After 3 and 5 weeks or oral contraceptive treatment, each subject received 300 IU Follegon or Metrodin in a random order. Frequent blood sampling was performed to measure immunoreactive FSH for pharmacokinetic analysis. After normalization for the immunodose administered, Follegon and Metrodin were bioequivalent with respect to the extent and the rate of absorption, the elimination half-life and plasma clearance per kg. The time taken to reach peak plasma FSH concentrations was shorter with Follegon than with Metrodin. Because bioequivalence was proved for the major pharmacokinetic variables, it can be assumed that Follegon and Metrodin are also equally effective inovulation induction, in-vitro fertilization and embryo transfer programmes and the treatment of male infertility.

Immunologic studies with urinary follicle stimulating hormone.

ABSTRACT Antiserum to human follicle stimulating hormone (FSH) partially purified from postmenopausal urine was produced in rabbits. The antiserum, after absorption with human chorionic gonadotropin (HCG) and pediatric urine extract (Peduex), was shown by immunodiffusion to react with the partially purified fraction of FSH and Pergonal-26 with a “line of identity,” but did not give a line against HCG or Peduex. The biologic activity of FSH in the ovarian augmentation assay was inhibited by the antiserum but that of HCG was not affected. As little as 0.035 IU of urinary FSH, in the form of Pergonal or Ortho-HMG, was capable of inhibiting the agglutination reaction between the FSH antiserum and latex particles coated with urinary FSH. HCG had only a slight inhibitory effect. The immunoactivity of these and other urinary FSH preparations was in good agreement with their biologic FSH activities. These results confirm the antigenicity of urinary FSH, indicate that an antiserum specific for FSH and free of anti...