OBJECTIVE: To evaluate the clinical effect of two different biochemical GnRH agonists (GnRH-a), nafarelin acetate and leuprolide acetate (LA), as adjunct to induction of ovulation in patients for IVF. DESIGN:Twenty-four women were assigned randomly to either nafarelin acetate or LA during IVF cycles. SETTING: University-affiliated clinics. PATIENTS: Infertile women undergoing IVF cycles in an academic research environment. INTERVENTIONS:Intranasal nafarelin at a dosage of 200 micrograms twice daily or LA at a dose of 1 mg/d SC was administered. Blood samples were collected on day 21 of previous cycle, days 2 and 8, and before hCG injection. MAIN OUTCOME MEASURE: Patient response as indicated by follicular phase serum levels of E2, FSH, and LH. RESULTS: Hormone profiles on cycle day 2 showed no statistical difference between both GnRH-a groups in FSH levels and a slight statistical difference for E2 levels. Patient response as demonstrated by follicular phase of E2, FSH, and LH measured on cycle day 8 and the day of hCG injection showed no statistically significant difference in both groups. Furthermore, the mean number of follicles, eggs retrieved, egg quality, fertilization rate, and number of embryos transferred and frozen were similar. The cycle cancellation rate and pregnancy rate per stimulation start were also not statistically different between the two groups. CONCLUSION: The study shows the comparable efficacy of these two drugs in controlled ovarian hyperstimulation (COH) protocols. The easy administration of nafarelin with prompt nasal absorption and the readily achieved blood level made nafarelin an option for use in COH in assisted reproductive technology.
RCT Entities:
OBJECTIVE: To evaluate the clinical effect of two different biochemical GnRH agonists (GnRH-a), nafarelin acetate and leuprolide acetate (LA), as adjunct to induction of ovulation in patients for IVF. DESIGN: Twenty-four women were assigned randomly to either nafarelin acetate or LA during IVF cycles. SETTING: University-affiliated clinics. PATIENTS: Infertile women undergoing IVF cycles in an academic research environment. INTERVENTIONS: Intranasal nafarelin at a dosage of 200 micrograms twice daily or LA at a dose of 1 mg/d SC was administered. Blood samples were collected on day 21 of previous cycle, days 2 and 8, and before hCG injection. MAIN OUTCOME MEASURE: Patient response as indicated by follicular phase serum levels of E2, FSH, and LH. RESULTS: Hormone profiles on cycle day 2 showed no statistical difference between both GnRH-a groups in FSH levels and a slight statistical difference for E2 levels. Patient response as demonstrated by follicular phase of E2, FSH, and LH measured on cycle day 8 and the day of hCG injection showed no statistically significant difference in both groups. Furthermore, the mean number of follicles, eggs retrieved, egg quality, fertilization rate, and number of embryos transferred and frozen were similar. The cycle cancellation rate and pregnancy rate per stimulation start were also not statistically different between the two groups. CONCLUSION: The study shows the comparable efficacy of these two drugs in controlled ovarian hyperstimulation (COH) protocols. The easy administration of nafarelin with prompt nasal absorption and the readily achieved blood level made nafarelin an option for use in COH in assisted reproductive technology.
Authors: J G Franco; R L Baruffi; A L Mauri; C G Petersen; J E Chufallo; V Felipe; E Garbellini Journal: J Assist Reprod Genet Date: 2001-11 Impact factor: 3.412