Induction of ovulation in World Health Organization group II anovulatory women undergoing follicular stimulation with recombinant human follicle-stimulating hormone: a comparison of recombinant human chorionic gonadotropin (rhCG) and urinary hCG

Objective: To compare the safety and efficacy of 250 mug recombinant hCG (r hCG) and 5,000 IU urinary hCG (uhCG), both administered s.c., for ovulation induction in anovulatory/oligo-ovulatory patients after follicular stimula tion with recombinant hFSH (rhFSH). Design: Phase III, double-blind, double-dummy, randomized, parallel-group, multicenter study. Setting: Nineteen academic and private tertiary care infertility centers in Europe, Israel, Canada, and Australia. Patient(s): One hundred ninety-eight WHO group II anovulatory women, aged 2 0 to 38 years. Intervention(s): Women were randomized to receive rhCG or uhCG after follic ular stimulation with rhFSH in a chronic low-dose protocol. Blood samples w ere collected and ultrasound examinations performed during stimulation and after hCG administration. Main Outcome Measure(s): Ovulation (midluteal serum progesterone greater th an or equal to 30 nmol/L), serum progesterone, hCG levels after hCG, pregna ncy, adverse events, local tolerability, and ovarian hyperstimulation syndr ome (OHSS) incidence. Result(s): Ovulation rates did not differ between groups: 95.3% for rhCG (n = 85) and 88.0% for uhCG (n = 92). The one-sided 95% confidence interval f or the observed difference fell above the predefined limit of -20%, indicat ing equivalence. Treatment was well tolerated, but more uhCG patients repor ted local reactions (particularly inflammation and pain) (P=.0001; logistic regression). Conclusion(s): Subcutaneous rhCG and uhCG show equivalent efficacy in ovula tion induction; however, rhCG is better tolerated. (Fertil Steril(R) 2001;7 5:1111-8. (C)2001 by American Society for Reproductive Medicine.).