Recombinant follicle-stimulating

A generalized allergic reaction to human menopausal gonadotropin (Pergonal) has been described during controlled ovarian hyperstimulation (40). In this case a desensitization protocol allowed the patient to complete her treatment cycle without further problems. Subsequently recombinant follicle stimulating hormone was used successfully and uneventfully. 

On occasion, there have even been such reactions to highly purified human products, notably FSH they can be managed by changing the treatment to intramuscular recombinant follicle stimulating hormone (41). 

Szilagyi A, Bartfai G, Manfai A, Koloszar S, Pal A, Szabo I. Low-dose ovulation induction with urinary gonadotropins or recombinant follicle stimulating hormone in patients with polycystic ovary syndrome. Gynecol Endocrinol 2004 18 17-22. 

Harrison S, Wolf T, Abuzeid MI. Administration of recombinant follicle stimulating hormone in a woman with allergic reaction to menotropin a case report. Gynecol Endocrinol 2000 14(3) 149-52. 

Loret de Mola JR, Kiwi R, Austin C, Goldfarb JM. Subclavian deep vein thrombosis associated with the use of recombinant follicle-stimulating hormone (Gonal-F) complicating mild ovarian hyperstimulation syndrome. Fertil Steril 2000 73(6) 1253-6. 

Storring, RL. et al.. Physicochemical Methods for predicting the biological potency of recombinant follicle stimulating hormone An international collaborative study of isoelectric focusing and capillary zone electrophoresis, Biologicals, 30, 217, 2002. 

Ovitrelle (tradename in EU, sold as Ovidrel in the USA and also known as choriogonadotropin alfa) is a recombinant hCG approved for general medical use in the EU and USA in 2001. It is indicated for the treatment of female infertility due to anovulation and for patients undergoing assisted reproductive technology. It is used to trigger final follicle maturation and luteinization after follicle stimulation. 

Table 1.10. Some pharmaceutical substances originally isolated from animal sources. While some are still produced by direct extraction from the native source, others are now also produced by direct chemical synthesis (e.g. peptides and some steroids), or by recombinant DNA technology (most of the pol5 peptide products). Abbreviations hGH = human growth hormone FSH=follicle stimulating hormone hCG=human chorionic gonadotrophin HSA=human serum albumin HBsAg=hepatitis B surface antigen...

Follitropin alpha, human follicle-stimulating hormone (hFSH), recombinant... 

Follicle-stimulating hormone (human clone lambda 15B beta-subunit protein moiety reduced [CAS for beta subunit] Follicle-stimulating hormone, recombinant [SY] rhFSH [SY]... 

In 71 women undergoing in vitro fertilization and embryo transfer using recombinant human follicle-stimulating hormone in doses sufficient to attain a pregnancy rate of 24% (10), the main adverse effect was mild pain at the site of injection (less than 20% of patients) but there were two cases of ovarian hyperstimulation syndrome. In less than 10% of patients, redness, swelling, or bruising was seen and one patient developed headache. 

When recombinant and urinary versions of follicle-stimulating hormone were compared under double-blind conditions in an in vitro fertilization program in a randomized, multicenter study (12), the former was more potent. There were no clinically relevant differences in safety between the two products and no cases of ovarian hyperstimulation syndrome. 

Out HI, Mannaerts BM, Driessen SG, Coeling H, Bennink HI. A prospective, randomized, assessor-blind, multicentre study comparing recombinant and urinary follicle stimulating hormone (Puregon versus Metrodin) in in-vitro fertilization. Hum Reprod 1995 10(10) 2534-40. 

Frydman R, Howies CM, Truong F. A double-blind, randomized study to compare recombinant human follicle stimulating hormone (FSH Gonal-F) with highly purified urinary FSH (Metrodin) HP) in women undergoing assisted reproductive techniques including intracytoplasmic sperm injection. The French Multicentre Trialists. Hum Reprod 2000 15(3) 520-5. 

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