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

2014-08-27 03:14:00 | BioPortfolio

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.

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Pregnancy

Intervention

metformin plus placebo, Metformin plus folic acid, placebo plus folic acid, placebo alone

Location

"Pugliese" Hospital
Catanzaro
Italy
88100

Status

Recruiting

Source

University Magna Graecia

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:00-0400

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