title: Prospective parallel randomized, double-blind, double-dummy controlled clinical trial comparing clomiphene citrate and metformin as the first-line treatment for ovulation induction in nonobese anovulatory women with polycystic ovary syndrome.
abstract: BACKGROUND
  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
  The goal of this study was to compare the effectiveness of metformin and CC administration as a first-line treatment in anovulatory women with PCOS.
  
  
  METHODS
  We describe a prospective parallel randomized, double-blind, double-dummy controlled clinical trial.
  
  
  METHODS
  The study was conducted at the University "Magna Graecia" of Catanzaro, Catanzaro, Italy.
  
  
  METHODS
  One hundred nonobese primary infertile anovulatory women with PCOS participated.
  
  
  METHODS
  We administered metformin cloridrate (850 mg twice daily) plus placebo (group A) or placebo plus CC (150 mg for 5 d from the third day of a progesterone withdrawal bleeding) (group B) for 6 months each.
  
  
  METHODS
  The main outcome measures were 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 205 and 221 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 was significantly higher in group A than group B (15.1 vs. 7.2%, P = 0.009). The difference found between groups A and B regarding the abortion rate was significant (9.7 vs. 37.5%, P = 0.045), whereas 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 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 nonobese PCOS women.
authors.affiliation: Department of Gynecology and Obstetrics, University Magna Graecia of Catanzar, Via Nicolardi 188, 80131 Naples, Italy. stefanopalomba@tin.it
authors.forename: Stefano
authors.initials: S
authors.lastname: Palomba
authors.forename: Francesco
authors.initials: F
authors.lastname: Orio
authors.forename: Angela
authors.initials: A
authors.lastname: Falbo
authors.forename: Francesco
authors.initials: F
authors.lastname: Manguso
authors.forename: Tiziana
authors.initials: T
authors.lastname: Russo
authors.forename: Teresa
authors.initials: T
authors.lastname: Cascella
authors.forename: Achille
authors.initials: A
authors.lastname: Tolino
authors.forename: Enrico
authors.initials: E
authors.lastname: Carmina
authors.forename: Annamaria
authors.initials: A
authors.lastname: Colao
authors.forename: Fulvio
authors.initials: F
authors.lastname: Zullo
mesh_terms: D000328:Adult; D000858:Anovulation / Q000188:drug therapy*; D002996:Clomiphene / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008687:Metformin / Q000627:therapeutic use*; D010062:Ovulation Induction; D011085:Polycystic Ovary Syndrome / Q000188:drug therapy*; D011247:Pregnancy; D011446:Prospective Studies
chemical_list: D002996:Clomiphene; D008687:Metformin