Does Short-term Structured Exercise Training Program Plus Diet Intervention Improve Ovarian Sensitivity to Clomiphene Citrate in Polycystic Ovary Syndrome Patients (PCOS)? A Prospective Randomized Controlled Study
Ninety-six PCOS patients considered CC-resistant because not responsive to 150 mg daily of
CC were randomized in three arms (group A, B, and C). Group A underwent SET program plus
hypocaloric diet for two months, group B had one month of observation followed by one-cycle
of CC therapy, and group C underwent SET program plus hypocaloric diet for two months and
received one-cycle of CC for one cycle. CC was always given at the maximal dose previously
used. Clinical, hormonal and metabolic data were assessed at baseline and after
intervention. Ovulation was monitored by ultrasound and confirmed by plasma progesterone
assay.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Ovulation rate
three months
No
Stefano Palomba, MD
Principal Investigator
University Magna Graecia
Italy: The Italian Medicines Agency
06/2009
NCT01004068
February 2008
October 2009
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