Recombinant Follicle‐Stimulating Hormone: New Biotechnology for Infertility

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Abstract
The frequency of infertility in developed countries is approximately 8–10%. New drugs are available for assisted reproduction techniques. Two recombinant follicle‐stimulating hormone (FSH) products, follitropin‐β (Follistim in the United States, Puregon in Europe) and follitropin‐α (Gonal‐F), join compounds derived through transfecting nonhuman cell lines with genetic material capable of replicating identical amino acid sequences to human compounds. The cell line used for recombinant (r)‐FSH production is the Chinese hamster ovary (CHO). Previously, the only agents that showed benefit in controlled ovulatory stimulation were derived from the urine of menopausal women. Those compounds contain additional substances, such as urinary proteins and various amounts of luteininzing hormone. The amino acid sequence of r‐FSH is identical to that of human FSH, but the two recombinant products exist in many different isoforms and differ from each other and from human FSH due to varied carbohydrate side chains. Due to variation in the carbohydrate side chains, follitropin‐β in solution has a higher pH than urine‐derived FSH, which enhances receptor affinity and therefore is a greater inducer of folliculogenesis. Follitropin‐β does not cause endogenous production of anti‐CHO or anti‐FSH antibodies, and is well tolerated.

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