OBJECTIVE: To explore the dose-response relationship of cotreatment with GH in the augmentation of the ovarian response to stimulation by gonadotropins. DESIGN: Patients were randomly allocated to receive hMG and GH (4, 12, 24 IU) or hMG and placebo on alternate days for up to seven injections. PATIENTS: Sixty-four women with hypogonadotropic hypogonadism in eight centers in Europe and one in Australia. MAIN OUTCOME MEASURES: Gonadotropin dosage as a function of GH dose. RESULTS: The mean total number of ampules of hMG (75 IU FSH/ampule) required was 37.2, 30.0, 25.6, and 22.3, respectively. There was also a significant dose-response relationship observed for the duration of gonadotropin therapy and final daily effective dose required. Serum insulin-like growth factor I concentrations increased as a function of GH dose. No significant difference in E2 concentrations, number of large follicles, or cancellation rate was noted between the four groups. There were significantly more pregnancies in the placebo groups compared with the GH groups. Nine adverse reactions were noted, one in the placebo and eight in the GH groups (1 in the 4-IU group, 5 in the 12-IU group, and 2 in the 24-IU group). CONCLUSIONS: We conclude that addition of GH to gonadotropin treatment exhibits a dose-related amplification of gonadotropin action on the ovary and reduction of gonadotropin dosage required to achieve ovulation induction. The study did not however define the minimum effective dose of GH for gonadotropin-stimulated ovulation induction.
RCT Entities:
OBJECTIVE: To explore the dose-response relationship of cotreatment with GH in the augmentation of the ovarian response to stimulation by gonadotropins. DESIGN:Patients were randomly allocated to receive hMG and GH (4, 12, 24 IU) or hMG and placebo on alternate days for up to seven injections. PATIENTS: Sixty-four women with hypogonadotropic hypogonadism in eight centers in Europe and one in Australia. MAIN OUTCOME MEASURES: Gonadotropin dosage as a function of GH dose. RESULTS: The mean total number of ampules of hMG (75 IU FSH/ampule) required was 37.2, 30.0, 25.6, and 22.3, respectively. There was also a significant dose-response relationship observed for the duration of gonadotropin therapy and final daily effective dose required. Serum insulin-like growth factor I concentrations increased as a function of GH dose. No significant difference in E2 concentrations, number of large follicles, or cancellation rate was noted between the four groups. There were significantly more pregnancies in the placebo groups compared with the GH groups. Nine adverse reactions were noted, one in the placebo and eight in the GH groups (1 in the 4-IU group, 5 in the 12-IU group, and 2 in the 24-IU group). CONCLUSIONS: We conclude that addition of GH to gonadotropin treatment exhibits a dose-related amplification of gonadotropin action on the ovary and reduction of gonadotropin dosage required to achieve ovulation induction. The study did not however define the minimum effective dose of GH for gonadotropin-stimulated ovulation induction.