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

• Published in: The journal of clinical endocrinology and metabolism 2004-10, Vol.89 (10), p.4801-4809
• Main Authors: Palomba, Stefano, Orio, Francesco, Nardo, Luciano Giovanni, Falbo, Angela, Russo, Tiziana, Corea, Domenico, Doldo, Patrizia, Lombardi, Gaetano, Tolino, Achille, Colao, Annamaria, Zullo, Fulvio
• Format: Article
• Language: English
• Subjects: Abortion; Adult; Ambulatory Surgical Procedures - economics; Biological and medical sciences; Body weight; Clomiphene; Clomiphene - therapeutic use; Double-Blind Method; Double-blind studies; Drug Resistance; Electrocoagulation - economics; Endocrinopathies; Female; Fertility Agents, Female - therapeutic use; Fundamental and applied biological sciences. Psychology; Humans; Hypoglycemic Agents - administration & dosage; Hypoglycemic Agents - adverse effects; Laparoscopy; Laparoscopy - economics; Medical sciences; Metformin; Metformin - administration & dosage; Metformin - adverse effects; Ovaries; Overweight; Ovulation; Patient Dropouts; Placebos; Polycystic ovary syndrome; Polycystic Ovary Syndrome - drug therapy; Polycystic Ovary Syndrome - surgery; Pregnancy; Pregnancy Outcome; Prospective Studies; Vertebrates: endocrinology
• ISSN: 0021-972X; 1945-7197
• DOI: 10.1210/jc.2004-0689

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.