A Phase 4 interventional study of metformin plus placebo and Metformin plus folic acid in Pregnancy and Polycystic Ovary Syndrome, sponsored by University Magna Graecia. Completed at 1 site in Italy. Open to female participants aged 18 Years to 38 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-05-24.
Sponsored by University Magna Graecia · Phase 4, Interventional, and Prevention
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.
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.
This study's enrollment of 50 is below the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →University Magna Graecia is the lead sponsor of 75 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
metformin plus placebo
Drug: metformin plus placebo
metformin plus folic acid
Drug: Metformin plus folic acid
placebo plus folic acid
Drug: placebo plus folic acid
placebo cp, 2 cps daily
Drug: placebo alone
observation
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
placebo cp, 2 cps daily
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
This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Magna Graecia