Objective: To compare the safety and efficacy of 250 microg recombinant hCG (rhCG) and 5,000 IU urinary hCG (uhCG), both administered s.c., for ovulation induction in anovulatory/oligo-ovulatory patients after follicular stimulation 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 20 to 38 years.
Intervention(s): Women were randomized to receive rhCG or uhCG after follicular stimulation with rhFSH in a chronic low-dose protocol. Blood samples were collected and ultrasound examinations performed during stimulation and after hCG administration.
Main outcome measure(s): Ovulation (midluteal serum progesterone > or =30 nmol/L), serum progesterone, hCG levels after hCG, pregnancy, adverse events, local tolerability, and ovarian hyperstimulation syndrome (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 for the observed difference fell above the predefined limit of -20%, indicating equivalence. Treatment was well tolerated, but more uhCG patients reported local reactions (particularly inflammation and pain) (P=.0001; logistic regression).
Conclusion(s): Subcutaneous rhCG and uhCG show equivalent efficacy in ovulation induction; however, rhCG is better tolerated.