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.


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


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


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


METHODS
Follicular development as defined by (i) at least one follicle >or= 17 mm; (ii) preovulatory serum oestradiol level >or= 109 pg/ml on the day of hCG administration; and (iii) midluteal phase P(4) level >or= 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.
Kaufmann
Robert
R
South-eastern Fertility Centre, PA, Mt. Pleasant, South Carolina, USA.
Dunn
Randall
R
Vaughn
Thomas
T
Hughes
Graeme
G
O'Brien
Fanny
F
Hemsey
George
G
Thomson
Barbara
B
O'Dea
Louis St L
LS
D000328:Adult; D004958:Estradiol / Q000097:blood; D005260:Female; D005300:Fertility Agents, Female / Q000627:therapeutic use*; D005640:Follicle Stimulating Hormone / Q000627:therapeutic use; D015292:Glycoprotein Hormones, alpha Subunit / Q000627:therapeutic use*; D006062:Gonadotropins / Q000172:deficiency*; D006801:Humans; D007006:Hypogonadism / Q000628:therapy*; D007247:Infertility, Female / Q000188:drug therapy*; D007986:Luteinizing Hormone / Q000627:therapeutic use*; D010062:Ovulation Induction / Q000379:methods; D011247:Pregnancy; D011256:Pregnancy Outcome; D012449:Safety
D005300:Fertility Agents, Female; D015292:Glycoprotein Hormones, alpha Subunit; D006062:Gonadotropins; D004958:Estradiol; D007986:Luteinizing Hormone; D005640:Follicle Stimulating Hormone