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The Journal of Clinical Endocrinology & Metabolism Vol. 89, No. 10 4801-4809
Copyright © 2004 by The Endocrine Society


Special Feature

Metformin Administration Versus Laparoscopic Ovarian Diathermy in Clomiphene Citrate-Resistant Women with Polycystic Ovary Syndrome: A Prospective Parallel Randomized Double-Blind Placebo-Controlled Trial

Stefano Palomba, Francesco Orio, Jr., Luciano Giovanni Nardo, Angela Falbo, Tiziana Russo, Domenico Corea, Patrizia Doldo, Gaetano Lombardi, Achille Tolino, Annamaria Colao and Fulvio Zullo

Departments of Obstetrics and Gynecology (S.P., A.F., T.R., D.C., F.Z.) and Experimental Medicine (P.D.), University "Magna Graecia" of Catanzaro, 88100 Catanzaro, Italy; Departments of Molecular and Clinical Endocrinology and Oncology (F.O., G.L., A.C.), and Obstetrics and Gynecology (A.T.), University "Federico II" of Naples, 80131 Naples, Italy; and Imperial College (L.G.N.), St. Mary’s Hospital, London W2 1NY, United Kingdom

Address all correspondence and requests for reprints to: Stefano Palomba, M.D., Department of Gynecology and Obstetrics, University "Magna Graecia" of Catanzaro, Via Nicolardi 188, 80131 Naples, Italy. E-mail: stefanopalomba{at}tin.it.

At present, it is unclear what the role is of laparoscopic ovarian diathermy (LOD) and of metformin administration as second-line treatments for ovulation induction in women with polycystic ovary syndrome (PCOS) after failure of clomiphene citrate (CC) treatment. The aim of the present study was to compare in a randomized double-blind placebo-controlled fashion the effectiveness of LOD with metformin administration in the treatment of CC-resistant women with PCOS. A total of 120 overweight primary infertile anovulatory CC-resistant women with PCOS were enrolled and randomized into two groups of treatment. Group A underwent diagnostic laparoscopy, whereas group B underwent LOD. At hospital discharge, the patients were treated for 6 months with metformin cloridrate (group A; 850 mg twice daily) or with multivitamins (group B). The ovulation, pregnancy, abortion, and live-birth rates were evaluated. At the end of the study, the total ovulation rate was not statistically different between both treatment groups (54.8 vs. 55.1% in groups A and B, respectively), whereas the pregnancy (18.6 vs. 13.4%), the abortion (15.4 vs. 29.0%), and the live-birth (82.1 vs. 64.5%) rates were significantly (P < 0.05) different between the two groups. Our data show that metformin administration is more effective than LOD in overall reproductive outcomes in overweight infertile CC-resistant women with PCOS.




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