Effect of Metformin With or Without Folate Addiction on Uterine Blood Flow and Trophoblastic Invasion in Pregnant Patients With Polycystic Ovary Syndrome
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Istologic evaluation of trophoblastic ivasion,
Fulvio Zullo, MD
Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Italy: The Italian Medicines Agency