Lutropin alfa: new preparation. Combined with follitropin for follicular development: no better than menotropin.

(1) The reference ovarian stimulant for women with severe FSH and LH deficiency and pituitary dysfunction is menotropin (postmenopausal urinary human gonadotrophin (hMG)). (2) A recombinant LH, lutropin alfa, has now been licensed for this use, in combination with recombinant FSH (follitropin alfa or follitropin beta). The evaluation file contains no data from trials comparing the follitropin-lutropin alfa combination with menotropin. (3) Two dose-finding studies involving a total of 78 women, and a double-blind trial comparing follitropin + placebo with follitropin + lutropin alfa, have shown that 75 IU/day lutropin alfa yields satisfactory follicular development in two-thirds of women whose plasma LH concentration is below 1.2 IU/I. Efficacy has not been demonstrated in women with higher plasma concentrations of LH. Similar results have been reported with menotropin. (4) The adverse effect profile of the follitropin + lutropin alfa combination is similar to that of menotropin. The main risk is an ovarian hyperstimulation syndrome. Monitoring of plasma estradiol concentrations, pelvic ultrasound findings, and clinical state are required to avoid severe ovarian hyperstimulation. There is no evidence that the risk differs between menotropin and the follitropin + lutropin alfa combination at adjusted doses. (5) In France, the combination of follitropin alfa + lutropin alfa costs about five times more than menotropin. (6) Menotropin remains the first line ovarian stimulant for women with severe deficiency of FSH and LH.