OBJECTIVE: To compare the efficacy, tolerability, and convenience of two formulations of the follitropin-alpha (Gonal-f) pen device versus the conventional form in Iranian women undergoing ovarian stimulation for intracytoplasmic sperm injection. DESIGN: Randomized, single-center trial, parallel-group, single blind. SETTING:Tertiary referral center, University Hospital. PATIENT(S): A total of 100 patients undergoing intracytoplasmic sperm injection. INTERVENTION(S): After down-regulation with busereline acetate, patients were randomized to receive the pen device or the conventional syringe of follitropin-alpha. A computer-generated randomization list was used to allocate the patients to one of these two groups. MAIN OUTCOME MEASURE(S): The primary outcomes were patients' satisfaction, convenience, occurrence of local tolerance symptoms, and pain. Total dose of follitropin-alpha, duration of follitropin-alpha treatment, number of oocyte retrieved, number of viable embryos, and clinical pregnancies were secondary outcome measures. Data collection was performed by means of a questionnaire designed for the purpose of this study. The pain scored according to the Visual Analogue Scale. RESULT(S): Self-administration and patients' satisfaction were significantly higher in the pen device group than the conventional syringe group. Local reactions at injection sites and pain were significantly higher in the conventional syringe group than in the pen device group. There were no statistically differences in secondary outcome measures and convenience between two groups. CONCLUSION(S): Among the Iranian patients that we studied, the pen device of Gonal-f is safe, convenient, and less painful, with more patients' satisfaction than the conventional syringe form, but both forms have equal efficacy in intracytoplasmic sperm injection cycles.
RCT Entities:
OBJECTIVE: To compare the efficacy, tolerability, and convenience of two formulations of the follitropin-alpha (Gonal-f) pen device versus the conventional form in Iranian women undergoing ovarian stimulation for intracytoplasmic sperm injection. DESIGN: Randomized, single-center trial, parallel-group, single blind. SETTING: Tertiary referral center, University Hospital. PATIENT(S): A total of 100 patients undergoing intracytoplasmic sperm injection. INTERVENTION(S): After down-regulation with busereline acetate, patients were randomized to receive the pen device or the conventional syringe of follitropin-alpha. A computer-generated randomization list was used to allocate the patients to one of these two groups. MAIN OUTCOME MEASURE(S): The primary outcomes were patients' satisfaction, convenience, occurrence of local tolerance symptoms, and pain. Total dose of follitropin-alpha, duration of follitropin-alpha treatment, number of oocyte retrieved, number of viable embryos, and clinical pregnancies were secondary outcome measures. Data collection was performed by means of a questionnaire designed for the purpose of this study. The pain scored according to the Visual Analogue Scale. RESULT(S): Self-administration and patients' satisfaction were significantly higher in the pen device group than the conventional syringe group. Local reactions at injection sites and pain were significantly higher in the conventional syringe group than in the pen device group. There were no statistically differences in secondary outcome measures and convenience between two groups. CONCLUSION(S): Among the Iranian patients that we studied, the pen device of Gonal-f is safe, convenient, and less painful, with more patients' satisfaction than the conventional syringe form, but both forms have equal efficacy in intracytoplasmic sperm injection cycles.
Authors: Marleen Nahuis; Fulco van der Veen; Jur Oosterhuis; Ben Willem Mol; Peter Hompes; Madelon van Wely Journal: Int J Womens Health Date: 2010-08-09