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Submitted on January 19, 2005
Accepted on April 6, 2005
Department of Obstetrics & Gynecology, University "Magna Graecia" of Catanzaro, Department of Molecular & Clinical Endocrinology and Oncology;, University "Federico II" of Naples, Department Internal Medicine, University "Federico II" of Naples, Department of Obstetrics & Gynecology, University "Federico II" of Naples, Department of Endocrinology, University of Palermo; Italy
* To whom correspondence should be addressed. E-mail: stefanopalomba{at}tin.it.
Context: Although metformin has been shown to be effective in the treatment of anovulation in women with polycystic ovary syndrome (PCOS), clomiphene citrate (CC) is still considered to be the first-line drug to induce ovulation in these patients.
Objective: To compare the effectiveness of metformin and CC administration as a first-line treatment in anovulatory women with PCOS.
Design: Prospective parallel randomized double-blind double-dummy controlled clinical trial.
Setting: University "Magna Graecia" of Catanzaro, Catanzaro, Italy.
Patients: One hundred non-obese primary infertile anovulatory women with PCOS.
Interventions: Metformin cloridrate (850 mg twice daily) plus placebo (group A) or placebo plus CC (150 mg for five days from 3rd day of a progesterone withdrawal bleeding) (group B) for six months each.
Mean outcome measures: Ovulation, pregnancy, abortion, and live-birth rates.
Results: The subjects of groups A (n = 45) and B (n = 47) were studied for a total of 221 and 205 cycles, respectively. The ovulation rate was not statistically different between either treatment group (62.9% vs. 67.0%, P = 0.38), whereas the pregnancy rate resulted significantly higher in group A than in group B (15.1% vs. 7.2%, P = 0.009). The differences found between groups A and B regarding the abortion rate resulted significant (9.7% vs. 37.5%, P = 0.045), while a positive trend was observed for the live-birth rate (83.9% vs. 56.3%, P = 0.07). The cumulative pregnancy rate was significantly higher in group A than in group B (68.9% vs. 34.0%, P < 0.001).
Conclusions: Six-month metformin administration is significantly more effective than six-cycle CC treatment in improving fertility in anovulatory non-obese PCOS women.
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