A more recent prospective nonrandomized placebo-controlled double-blind clinical study demonstrated that metformin exerts a slight but significant deleterious effect on serum homocysteine (Hcy) levels in patients with PCOS, and supplementation with folate is useful to increase the beneficial effect of metformin on the vascular endothelium.
PCOS (cases) and non-PCOS (controls) pregnant women were enrolled. Cases will be randomized in four treatment groups: metformin plus placebo (group A1), metformin plus folic acid (group A2), placebo plus folic acid (group A3), placebo alone (group A4). Controls will not received any treatment (group B). Clinical and biochemical assessment (including serum markers of implantation), Doppler velocimetry of the uterine arteries, and trophoblastic invasion at histological and immunohistochemical evaluation. Changes in clinical and biochemical data under treatment, pattern of Doppler velocimetry at the uterine arteries, and trophoblastic invasion were evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
50
metformin 850 mg cp, 2 cps daily
metformin 850 mg cp, 2 cps daily plus folic acid 0.4 mg daily
Placebo 1 cp daily plus folic acid 0.4 mg daily
"Pugliese" Hospital
Catanzaro, Catanzaro, Italy
Trophoblastic invasion.
Istologic evaluation of trophoblastic ivasion,
Time frame: two weeks
Doppler velocimetry measurements of the uterine artery.
Ultrasonographyc assessment of Doppler velocimetry measurements of the uterine artery.
Time frame: two weeks
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placebo cp, 2 cps daily