OBJECTIVE: To study the effectiveness of clomiphene citrate (CC) in preventing a premature LH surge during controlled ovarian stimulation in women undergoing assisted reproduction. DESIGN: Prospective, randomized, controlled trial. SETTING:University hospital. PATIENT(S): Two-hundred thirty couples with mild male factor, or unexplained infertility. INTERVENTION(S): Couples were randomized to receive human menopausal gonadotrophins (hMG) followed by CC or hMG alone until the day of hCG. MAIN OUTCOME MEASURE(S): The primary outcomes were the incidence of a clinical pregnancy and premature LH rise. Secondary outcomes were the E2 levels, number of mature follicles, and endometrial thickness as determined on the day of hCG. RESULT(S): The number of patients who had a premature LH surge was significantly lower in the hMG+CC group (5.45% vs. 15.89%). Additionally, the mean E2 levels (pg/mL) and the number of mature follicles were also significantly higher in the hMG+CC group (360.3±162.9 vs. 280±110.0 and 2.4±0.97 vs. 1.3±1.1, respectively), although there was no significant difference regarding number of canceled cycles, endometrial thickness, or clinical pregnancy rate. CONCLUSION(S): The addition of CC to hMG has been proven to be effective in reducing premature LH surges without compromising the pregnancy rate.
RCT Entities:
OBJECTIVE: To study the effectiveness of clomiphene citrate (CC) in preventing a premature LH surge during controlled ovarian stimulation in women undergoing assisted reproduction. DESIGN: Prospective, randomized, controlled trial. SETTING: University hospital. PATIENT(S): Two-hundred thirty couples with mild male factor, or unexplained infertility. INTERVENTION(S): Couples were randomized to receive human menopausal gonadotrophins (hMG) followed by CC or hMG alone until the day of hCG. MAIN OUTCOME MEASURE(S): The primary outcomes were the incidence of a clinical pregnancy and premature LH rise. Secondary outcomes were the E2 levels, number of mature follicles, and endometrial thickness as determined on the day of hCG. RESULT(S): The number of patients who had a premature LH surge was significantly lower in the hMG+CC group (5.45% vs. 15.89%). Additionally, the mean E2 levels (pg/mL) and the number of mature follicles were also significantly higher in the hMG+CC group (360.3±162.9 vs. 280±110.0 and 2.4±0.97 vs. 1.3±1.1, respectively), although there was no significant difference regarding number of canceled cycles, endometrial thickness, or clinical pregnancy rate. CONCLUSION(S): The addition of CC to hMG has been proven to be effective in reducing premature LH surges without compromising the pregnancy rate.
Authors: Mohan S Kamath; Priya Bhave; Tk Aleyamma; Raju Nair; A Chandy; Ann M Mangalaraj; K Muthukumar; Korula George Journal: J Hum Reprod Sci Date: 2010-09