Spots Global Cancer Trial Database for Metformin and Folate in Pregnant Polycystic Ovary Syndrome(PCOS) Women

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Trial Identification

Brief Title: Metformin and Folate in Pregnant Polycystic Ovary Syndrome(PCOS) Women

Official Title: Effect of Metformin With or Without Folate Addiction on Uterine Blood Flow and Trophoblastic Invasion in Pregnant Patients With Polycystic Ovary Syndrome

Study ID: NCT01115140

Conditions

Pregnancy

Polycystic Ovary Syndrome

Interventions

metformin plus placebo

Metformin plus folic acid

placebo plus folic acid

placebo alone

Study Description

Brief Summary: 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.

Detailed Description: 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.