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.
RCT Entities:
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.
Authors: R Matorras; A Meabe; R Mendoza; B Prieto; O Ramón; J Mugica; F Aspichueta; A Exposito Journal: J Assist Reprod Genet Date: 2012-07-20 Impact factor: 3.412
Authors: Vicente Abdelmassih; Flavio G Oliveira; Sergio P Goncalves; Adriana D Varella; Michael P Diamond; Roger Abdelmassih Journal: J Assist Reprod Genet Date: 2005-04 Impact factor: 3.412