Laparoscopic Ovarian Diathermy or Metformin Plus Clomiphene Citrate Administration as Second-Line Treatment for Infertile Anovulatory Patients With Polycystic Ovary Syndrome: a Randomized Controlled Trial
A total of 50 primary infertile anovulatory PCOS patients with documented CC-resistance will
be enrolled and randomized into two groups of treatment of 25 subjects each. Group A will
undergo diagnostic laparoscopy followed by metformin plus CC, whereas group B will undergo
LOD followed by observation. Anovulatory patients will receive IM progesterone. The
treatment will be of six months followed by nine-month of observation for pregnant patients.
The incidence of spontaneous menses, and the pregnancy, abortion, and live-birth rates will
be recorded.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Live-birth rate
fifteen months
Stefano Palomba, MD
Principal Investigator
Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Italy: The Italian Medicines Agency
01/2003
NCT00558077
February 2003
October 2005
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