NCT01115140

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University Magna Graecia · Academic / Other
• Sex: Female
• Age: 18 Years – 38 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pregnancy
• Polycystic Ovary Syndrome

Interventions

Type	Name	Description
DRUG	metformin plus placebo	metformin 850 mg cp, 2 cps daily
DRUG	Metformin plus folic acid	metformin 850 mg cp, 2 cps daily plus folic acid 0.4 mg daily
DRUG	placebo plus folic acid	Placebo 1 cp daily plus folic acid 0.4 mg daily
DRUG	placebo alone	placebo cp, 2 cps daily

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2010-05-04
• Last updated: 2011-05-24

Locations

1 site across 1 country: Italy