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 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).


METHODS
Phase III, double-blind, double-dummy, randomized, parallel-group, multicenter study.


METHODS
Nineteen academic and private tertiary care infertility centers in Europe, Israel, Canada, and Australia.


METHODS
One hundred ninety-eight WHO group II anovulatory women, aged 20 to 38 years.


METHODS
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.


METHODS
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.


RESULTS
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).


CONCLUSIONS
Subcutaneous rhCG and uhCG show equivalent efficacy in ovulation induction; however, rhCG is better tolerated.
D000328:Adult; D000858:Anovulation / Q000188:drug therapy* / Q000503:physiopathology; D006063:Chorionic Gonadotropin / Q000009:adverse effects / Q000627:therapeutic use* / Q000652:urine; D004311:Double-Blind Method; D005260:Female; D005640:Follicle Stimulating Hormone / Q000627:therapeutic use*; D006801:Humans; D006080:Ovarian Follicle / Q000187:drug effects*; D010060:Ovulation; D010062:Ovulation Induction / Q000009:adverse effects; D011247:Pregnancy; D011256:Pregnancy Outcome; D011994:Recombinant Proteins; D012449:Safety; D016896:Treatment Outcome; D014944:World Health Organization
D006063:Chorionic Gonadotropin; D011994:Recombinant Proteins; D005640:Follicle Stimulating Hormone