Prospective parallel randomized double-blind double-dummy controlled clinical trial comparing clomiphene citrate and metformin as the first line treatment for ovulation induction in non-obese anovulatory women with polycystic ovary syndrome

Enrico Carmina, Annamaria Colao, Stefano Palomba, Teresa Cascella, Francesco Manguso, Francesco Orio Jr., Achille Tolino, Fulvio Zullo, Tiziana Russo, Angela Falbo, Tiziana Russo

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219 Citazioni (Scopus)

Abstract

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: 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. Design: We describe a prospective parallel randomized, double-blind, double-dummy controlled clinical trial. Setting: The study was conducted at the University "Magna Graecia" of Catanzaro, Catanzaro, Italy. Patients: One hundred nonobese primary infertile anovulatory women with PCOS participated. Interventions: 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. Mean outcome measures: 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. Conclusions: Six-month metformin administration is significantly more effective than six-cycle CC treatment in improving fertility in anovulatory nonobese PCOS women.
Lingua originaleEnglish
pagine (da-a)4068-4074
Numero di pagine7
RivistaTHE JOURNAL OF CLINICAL ENDOCRINOLOGY AND METABOLISM
Volume90
Stato di pubblicazionePublished - 2005

All Science Journal Classification (ASJC) codes

  • Endocrinology, Diabetes and Metabolism
  • Biochemistry
  • Endocrinology
  • Clinical Biochemistry
  • Biochemistry, medical

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