title: 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.
abstract: 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.
mesh_terms: 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
chemical_list: D006063:Chorionic Gonadotropin; D011994:Recombinant Proteins; D005640:Follicle Stimulating Hormone