OBJECTIVE: To compare the effectiveness of clomifene citrate plus metformin and clomifene citrate plus placebo in women with newly diagnosed polycystic ovary syndrome. DESIGN: Randomised clinical trial. SETTING: Multicentre trial in 20 Dutch hospitals. PARTICIPANTS: 228 women with polycystic ovary syndrome. INTERVENTIONS:Clomifene citrate plus metformin or clomifene citrate plus placebo. MAIN OUTCOME MEASURE: The primary outcome measure was ovulation. Secondary outcome measures were ongoing pregnancy, spontaneous abortion, and clomifene resistance. RESULTS:111 women were allocated to clomifene citrate plus metformin (metformingroup) and 114 women were allocated to clomifene citrate plus placebo (placebo group). The ovulation rate in the metformin group was 64% compared with 72% in the placebo group, a non-significant difference (risk difference - 8%, 95% confidence interval - 20% to 4%). There were no significant differences in either rate of ongoing pregnancy (40% v 46%; - 6%, - 20% to 7%) or rate of spontaneous abortion (12% v 11%; 1%, - 7% to 10%). A significantly larger proportion of women in the metformin group discontinued treatment because of side effects (16% v 5%; 11%, 5% to 16%). CONCLUSION:Metformin is not an effective addition to clomifene citrate as the primary method of inducing ovulation in women with polycystic ovary syndrome. TRIAL REGISTRATION: Current Controlled Trials ISRCTN55906981 [controlled-trials.com].
RCT Entities:
OBJECTIVE: To compare the effectiveness of clomifene citrate plus metformin and clomifene citrate plus placebo in women with newly diagnosed polycystic ovary syndrome. DESIGN: Randomised clinical trial. SETTING: Multicentre trial in 20 Dutch hospitals. PARTICIPANTS: 228 women with polycystic ovary syndrome. INTERVENTIONS:Clomifene citrate plus metformin or clomifene citrate plus placebo. MAIN OUTCOME MEASURE: The primary outcome measure was ovulation. Secondary outcome measures were ongoing pregnancy, spontaneous abortion, and clomifene resistance. RESULTS: 111 women were allocated to clomifene citrate plus metformin (metformin group) and 114 women were allocated to clomifene citrate plus placebo (placebo group). The ovulation rate in the metformin group was 64% compared with 72% in the placebo group, a non-significant difference (risk difference - 8%, 95% confidence interval - 20% to 4%). There were no significant differences in either rate of ongoing pregnancy (40% v 46%; - 6%, - 20% to 7%) or rate of spontaneous abortion (12% v 11%; 1%, - 7% to 10%). A significantly larger proportion of women in the metformin group discontinued treatment because of side effects (16% v 5%; 11%, 5% to 16%). CONCLUSION:Metformin is not an effective addition to clomifene citrate as the primary method of inducing ovulation in women with polycystic ovary syndrome. TRIAL REGISTRATION: Current Controlled Trials ISRCTN55906981 [controlled-trials.com].
Authors: Babak Imani; Marinus J C Eijkemans; Egbert R te Velde; J Dik F Habbema; Bart C J M Fauser Journal: Fertil Steril Date: 2002-01 Impact factor: 7.329
Authors: Johannes Ott; Christine Kurz; Kazem Nouri; Stefan Wirth; Elisabeth Vytiska-Binstorfer; Johannes C Huber; Klaus Mayerhofer Journal: Reprod Biol Endocrinol Date: 2010-05-13 Impact factor: 5.211