Recombinant human luteinizing hormone, lutropin alfa, for the induction of follicular development and pregnancy in profoundly gonadotrophin-deficient women

Objective To provide evidence of efficacy and safety for use of lutropin alfa in inducing follicular development and pregnancy in hypogonadotrophic hypogonadal women with profound gonadotrophin deficiency.

Design An open-label, noncomparative extension of a randomized, double-blind, placebo-controlled study

Patients A total of 31 hypogonadotrophic hypogonadal women with profound gonadotrophin deficiency in 23 medical centres in four countries were studied.

Interventions Lutropin alfa 75 IU and follitropin alfa (75–225 IU), individually based on each patient's response as is consistent with usual medical practice.

Measurements Follicular development as defined by (i) at least one follicle ≥ 17 mm; (ii) preovulatory serum oestradiol level ≥ 109 pg/ml on the day of hCG administration; and (iii) midluteal phase P₄ level ≥ 7·9 ng/ml. Pregnancy and over-response leading to cycle cancellation were considered treatment successes. Pregnancy rates were assessed.

Results In a total of 54 cycles, 27 of 31 (87·1%) profoundly gonadotrophin-deficient patients achieved follicular development within three cycles. Twenty of 27 patients (74·1%) who achieved follicular development and received hCG became pregnant; 16 (59·3%) continued to clinical pregnancy. One patient was hospitalized for severe ovarian hyperstimulation syndrome. Lutropin alfa was well tolerated.

Conclusions Coadministration of lutropin alfa 75 IU and follitropin alfa is safe and effective in inducing follicular development and pregnancy in hypogonadotrophic hypogonadal women with profound gonadotrophin deficiency in a setting consistent with established medical practice.