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Brief Title: Second-Line Treatments for Anovulatory Infertility in PCOS Patients
Official Title: 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
Study ID: NCT00558077
Brief Summary: To date, it is still unclear the potential role of laparoscopic ovarian diathermy (LOD) in the management of polycystic ovary syndrome (PCOS)-related anovulatory infertility. Metformin administration, alone or combined with clomiphene citrate (CC), has shown to be an effective and attractive second-line treatment for ovulation induction in women with polycystic ovary syndrome (PCOS) after failure of CC treatment. The aim of the present study will be to compare in a randomized controlled fashion the efficacy of LOD with metformin plus CC administration in the treatment of the CC-resistant PCOS patients.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
"Pugliese" Hospital, Catanzaro, Catanzaro/Italy, Italy
Name: Stefano Palomba, MD
Affiliation: Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Role: PRINCIPAL_INVESTIGATOR
Name: Fulvio Zullo, MD
Affiliation: Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Role: STUDY_CHAIR