title: A prospective, randomized, controlled, double-blind, double-dummy comparison of recombinant and urinary HCG for inducing oocyte maturation and follicular luteinization in ovarian stimulation.
abstract: A randomized, controlled, double-blind, double-dummy, phase III clinical trial was conducted in 84 women to compare the efficacy of a s.c. injection of 250 microg recombinant human chorionic gonadotrophin (rHCG; Ovidrel) to an i.m. injection of 5000 IU urinary HCG (uHCG; Profasi) in inducing folliculogenesis, resumption of oocyte meiosis and luteinization after ovulation induction with recombinant follicle stimulating hormone (Gonal-F). The study primary endpoint was comparison of the number of oocytes retrieved per patient receiving either compound. Secondary comparisons included the number of oocytes retrieved per follicles aspirated; the number of mature oocytes; normally fertilized oocytes; and cleaved embryos. There were no statistically significant differences between groups for the primary endpoint (mean +/- SD oocytes retrieved 10.8 +/- 4.5 for rHCG versus 10.3 +/- 5.1 for uHCG) or each of the secondary endpoints except for increased concentrations of progesterone 6-7 days after rHCG administration (353.2 +/- 215.1 versus 234.1 +/- 129.4 nmol/l; P < 0. 004) and for HCG during the luteal phase following rHCG (P < 0.02). There were also no significant side-effects for either drug. Since the confidence intervals for the difference of the number of oocytes retrieved between the two treatment groups were within the bounds defined by the multi-trial protocol equivalence between rHCG and uHCG could be declared.
authors.affiliation: City West IVF, Westmead, NSW, Australia.
authors.forename: G L
authors.initials: GL
authors.lastname: Driscoll
authors.forename: J P
authors.initials: JP
authors.lastname: Tyler
authors.forename: J T
authors.initials: JT
authors.lastname: Hangan
authors.forename: P R
authors.initials: PR
authors.lastname: Fisher
authors.forename: M A
authors.initials: MA
authors.lastname: Birdsall
authors.forename: D C
authors.initials: DC
authors.lastname: Knight
mesh_terms: D000328:Adult; D002452:Cell Count; D016922:Cellular Senescence; D006063:Chorionic Gonadotropin / Q000009:adverse effects / Q000627:therapeutic use* / Q000652:urine; D003338:Corpus Luteum / Q000187:drug effects / Q000503:physiopathology*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007247:Infertility, Female / Q000503:physiopathology / Q000628:therapy; D009865:Oocytes / Q000187:drug effects* / Q000502:physiology*; D006080:Ovarian Follicle / Q000187:drug effects / Q000503:physiopathology*; D010053:Ovary / Q000187:drug effects / Q000503:physiopathology*; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D013048:Specimen Handling
chemical_list: D006063:Chorionic Gonadotropin; D011994:Recombinant Proteins