Outcome of in vitro fertilization following stimulation with highly purified hMG or recombinant FSH in downregulated women of advanced reproductive age: a prospective, randomized and controlled trial.

OBJECTIVE: To compare highly purified human menopausal gonadotropin (HP-hMG) with recombinant follicle-stimulating hormone (rFSH) on ovarian response and pregnancy outcome in downregulated women of advanced reproductive age.

DESIGN: A prospective, randomized and controlled study of 127 consecutive normogonadotropic infertile women ≥ 35 years old undergoing their first in vitro fertilization/intracytoplasmic sperm injection cycles received ovarian stimulation with HP-hMG (n = 63) or with rFSH (n = 64) in a long gonadotropin-releasing hormone agonist protocol.

RESULTS: More leading (≥ 18 mm) follicles and oocytes were obtained in rFSH group (p = 0.008 and p < 0.001, respectively). The proportion of top-quality embryo from oocyte retrieval and live birth rate per started cycle trended towards improvement with HP-hMG (OR 1.3, 95% CI 0.9-1.8; OR 1.9, 95% CI 0.9-3.9; respectively), although they were not significant difference between two groups. At end of stimulation, higher serum progesterone level was found in rFSH group (p < 0.001).

CONCLUSION: Following downregulated women of advanced reproductive age, superiority of HP-hMG over rFSH in live birth rate could not be concluded from this study, but noninferiority was established. Pharmacodynamic differences in follicular development, oocyte/embryo quality and endocrine response exist between HP-hMG and rFSH, which may be relevant to treatment outcome.