Trial Information

Polycystic ovarian syndrome (PCOS) is a common endocrine disorder that causes infertility
due to anovulation in women of reproductive age. Anovulation and also decreased oocyte and
embryo quality may be cause of infertility in women with PCOS. Furthermore, the reactive
oxygen species (ROS) induce oxidative stress which may be responsible for poor oocyte
quality. The ROS generation from mononuclear cells is elevated in women with PCOS and a
significant increment of lipid peroxidation products in women with PCOS has been reported.

Melatonin is a documented powerful free radical scavenger and a broad spectrum antioxidant.
It has been observed that a non-PCOS group co-treated with inositol, folic acid, and
melatonin (Inofolic Plus by LO.LI.Pharma) results in a significantly greater mean number of
mature oocytes, and a lower mean number of immature oocytes in patients with low oocyte
quality history when compared to treatment only with inositol and folic acid (Inofolic by
LO.LI.Pharma).

The aim of the study is to evaluate the possible effects of melatonin supplementation on the
main IVF outcomes during ovarian stimulation of patients with PCOS.

From July 2009 to December 2011, 358 patients with PCOS (Rotterdam criteria) were enrolled
in this prospective randomized controlled trial.