Subcutaneously administered Menopur(R), a new highly purified human menopausal gonadotropin, causes significantly fewer injection site reactions than Repronex(R) in subjects undergoing in vitro fertilization

Keye, William R.; Webster, Bobby W.; Dickey, Richard P.; Somkuti, Stephen G.; Crain, J.L.; Scobey, M. Joseph

doi:10.1186/1477-7827-3-62

Cited by 7 publications

(3 citation statements)

References 9 publications

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“…The first gonadotropin medication introduced to clinical practice was the human menopausal gonadotropin (hMG), which was purified from urine of menopausal women [4]. To improve the safety and convenience of the administration of human gonadotropins, highly purified urinary follicle-stimulating hormone (HP-uFSH) and hMG (HP-hMG) were developed and used for more than four decades [5][6][7][8]. Although their purity increased compared to the initial preparations, they were still contaminated with urine proteins that might cause side effects, such as allergic reactions.…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and safety of recombinant human follicle-stimulating hormone in patients undergoing in vitro fertilization-embryo transfer

Song

et al. 2020

Aging

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To compare the ovarian responses after administration of two recombinant follicle-stimulating hormone (r-FSH) preparations under gonadotropin-releasing hormone (GnRH) analogue downregulation, we conducted a phase 3, randomized, multicenter, assessor-blind, active-controlled, parallel group study. The primary outcome was the number of oocytes retrieved. The secondary outcomes included total dose and duration of r-FSH administered, oocyte quality, blood estradiol levels, follicular development, fertilization rates, implantation rates, and pregnancy rates (biochemical, clinical, and ongoing). A total of 451 patients with infertility were randomized to receive either Follitrope™ Prefilled Syringe or Gonal-F ® Pen for ovarian stimulation. The mean number of oocytes retrieved was 14.9 in the Follitrope TM Prefilled Syringe group, and 12.8 in the Gonal-F ® Pen group. The 95% confidence interval in the oocyte number difference between the groups was [-0.1, 4.2], demonstrating that Follitrope TM Prefilled Syringe was not inferior to Gonal-F ® Pen. The clinical pregnancy rates (Follitrope TM Prefilled Syringe vs. Gonal-F ® Pen: 55.4% vs. 51.9%) and ongoing pregnancy rates (44.1% vs. 43.0%) were similar between the groups. No clinically significant adverse events were observed in either group. In summary, our study indicates that Follitrope TM Prefilled Syringe is safe and efficacious for ovarian stimulation.

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Section: Introductionmentioning

confidence: 99%

“…Moreover, the dependence on urine collection represented another problem. Development of the commercially produced recombinant FSH (r-FSH) by using recombinant DNA technology produced highly purified and effective FSH preparations, with batch-to-batch consistency for the treatment of infertility [8][9][10].…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of recombinant human follicle-stimulating hormone in patients undergoing in vitro fertilization-embryo transfer

Song

et al. 2020

Aging

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“…Human menopausal gonadotropins (hMG) containing both FSH and LH activities, purified from the urine of post-menopausal women, have been used successfully in the clinical setting for many years. Advances in purification techniques have led to a new generation of hMG preparations that are very consistent in their FSH and LH bio-activities [ 1 ]. In recent years, genetic engineering technology has allowed for the production of recombinant (r)FSH.…”

Section: Introductionmentioning

confidence: 99%

Differential gene expression in human granulosa cells from recombinant FSH versus human menopausal gonadotropin ovarian stimulation protocols

Brannian

Eyster

Mueller

et al. 2010

Reprod Biol Endocrinol

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BackgroundThe study was designed to test the hypothesis that granulosa cell (GC) gene expression response differs between recombinant FSH and human menopausal gonadotropin (hMG) stimulation regimens.MethodsFemales < 35 years-old undergoing IVF for tubal or male factor infertility were prospectively randomized to one of two stimulation protocols, GnRH agonist long protocol plus individualized dosages of (1) recombinant (r)FSH (Gonal-F) or (2) purified human menopausal gonadotropin (hMG; Menopur). Oocytes were retrieved 35 h post-hCG, and GC were collected. Total RNA was extracted from each GC sample, biotinylated cRNA was synthesized, and each sample was run on Human Genome Bioarrays (Applied Microarrays). Unnamed genes and genes with <2-fold difference in expression were excluded.ResultsAfter exclusions, 1736 genes exhibited differential expression between groups. Over 400 were categorized as signal transduction genes, ~180 as transcriptional regulators, and ~175 as enzymes/metabolic genes. Expression of selected genes was confirmed by RT-PCR. Differentially expressed genes included A kinase anchor protein 11 (AKAP11), bone morphogenetic protein receptor II (BMPR2), epidermal growth factor (EGF), insulin-like growth factor binding protein (IGFBP)-4, IGFBP-5, and hypoxia-inducible factor (HIF)-1 alpha.ConclusionsResults suggest that major differences exist in the mechanism by which pure FSH alone versus FSH/LH regulate gene expression in preovulatory GC that could impact oocyte maturity and developmental competence.

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Highly Purified Human Menopausal Gonadotropin (Menopur®): A Profile of Its Use in Infertility

Deeks

2018

Clin Drug Investig

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Subcutaneously administered Menopur(R), a new highly purified human menopausal gonadotropin, causes significantly fewer injection site reactions than Repronex(R) in subjects undergoing in vitro fertilization

Abstract: Background: The safety and tolerability of a new highly purified, urine-derived human menopausal gonadotropin (hMG) preparation [Menopur(R)] was compared with a currently available hMG [Repronex (R)] in women undergoing in vitro fertilization (IVF).

Cited by 7 publications

References 9 publications

Efficacy and safety of recombinant human follicle-stimulating hormone in patients undergoing in vitro fertilization-embryo transfer

Efficacy and safety of recombinant human follicle-stimulating hormone in patients undergoing in vitro fertilization-embryo transfer

Differential gene expression in human granulosa cells from recombinant FSH versus human menopausal gonadotropin ovarian stimulation protocols

Highly Purified Human Menopausal Gonadotropin (Menopur®): A Profile of Its Use in Infertility

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