The effectiveness and safety of recombinant human LH to support follicular development induced by recombinant human FSH in WHO group I anovulation:: evidence from a multicentre study in Spain

BACKGROUND: Until recently, human menopausal gonadotrophin (HMG), a urinary extract containing a fixed combination of LH and FSH, was the only source of exogenous LH for women with hypogonadotrophic hypogonadism undergoing ovulation induction with gonadotrophins. Recombinant human LH (rLH) is now available for clinical use, providing a new treatment option but clinical data on its use are scanty. Therefore, the aim of the present study was to investigate the efficacy and safety of rLH combined with recombinant FSH (rFSH) to induce follicular development and ovulation in World Health Organization (WHO) group I anovulatory women. METHODS: We included in this multicentre study 38 hypogonadotrophic anovulatory (WHO group I) women. Patients received 150 IU/day rFSH and 75 IU/day rLH (with the possibility of dose adjustment) as a single s.c. injection for up to three cycles with a total of 84 treatment cycles. RESULTS: Sufficient follicular growth was observed in 79 (94%) out of 84 initiated cycles. The 75 IU rLH dose was found to be effective in most treatment cycles (94%) and only five cycles in three patients required daily dose increase. Overall, HCG was administered to trigger ovulation in 67 (80%) of the 84 cycles while it was withheld in 12 cycles (14%) due to ovarian hyper-response and five cycles (6%) were cancelled for insufficient follicular growth. The pregnancy rate per started treatment cycle and per cycle given HCG was 18 and 22.4% respectively. Pregnancy was achieved by 15 (39.5%) of the 38 patients. Mild to moderate ovarian hyperstimulation syndrome occurred in three patients. Local tolerance was good. CONCLUSIONS: This study confirms that combined rFSH and rLH treatment induces follicular growth, ovulation and pregnancy in a good proportion of hypogonadotrophic anovulatory patients and is well tolerated. The doses of 150 IU rFSH and 75 IU rLH daily seem the most appropriate but in a small minority of patients doses > 75 IU rLH/day may be necessary.