Alternative sources for better and safer products

Recombinant LH and hCG

Luteinising hormone (LH), a glycoprotein produced in the anterior pituitary, plays an important role in normal reproductive function. In the majority of patients undergoing treatment for infertility, FSH therapy alone is highly effective in inducing follicular growth since the patient has enough endogenous LH. Less than 5% of all infertile patients have severe deficiency in both FSH and LH (hypogonadotrophic hypogonadism); in these patients, co-therapy with a daily low dose (75 IU) of LH is essential to induce follicular growth. At intermediate dose (450 IU), studies suggest that LH may be useful in minimizing the number of pre-ovulatory follicles when treating anovulatory PCOD patients, in order to reduce the risk of multiple pregnancies. Finally, at high dose (20,000 IU), LH is as effective as hCG in inducing final follicular maturation and early luteinization, and is associated with significantly lower incidence of ovarian hyperstimulation syndrome.

For many years, the only source of LH was human menopausal gonadotrophins (hMG), extracted from the urine of postmenopausal women. These preparations contained LH as well as FSH, hCG and many other urinary proteins. Serono developed recombinant LH produced in CHO cells; this is the first pharmaceutical presentation of LH free of other gonadotrophins. It therefore represents an important development in the treatment of infertility. Serono recently received a positive opinion for its r-hLH preparation by the European CPMP.

Serono has also used genetic engineering to produce recombinant human chorionic gonadotrophin (hCG), a hormone which stimulates ovarian steroid production in support of early stages of pregnancy. Traditionally, hCG was derived from the urine of pregnant women. Several clinical trials have shown that the recombinant product is as effective as the urinary product in inducing final follicular maturation and early luteinization. The product will soon reach the market.