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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01115140

Enrollment

Registered

2010-05-04

Start date

2010-03-31

Completion date

2011-05-31

Last updated

2011-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome, Pregnancy

Keywords

Folate, Metformin, PCOS, Pregnancy, Trophoblastic invasion, Uterine artery velocimetry

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.

Interventions

DRUGmetformin plus placebo

metformin 850 mg cp, 2 cps daily

DRUGMetformin plus folic acid

metformin 850 mg cp, 2 cps daily plus folic acid 0.4 mg daily

DRUGplacebo plus folic acid

Placebo 1 cp daily plus folic acid 0.4 mg daily

DRUGplacebo alone

placebo cp, 2 cps daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 38 Years

Healthy volunteers

Yes

Inclusion criteria

* Pregnancy * PCOS

Exclusion criteria

* Risk factors for pregnancy complications * Severe obesity

Design outcomes

Primary

Measure	Time frame	Description
Trophoblastic invasion.	two weeks	Istologic evaluation of trophoblastic ivasion,

Secondary

Measure	Time frame	Description
Doppler velocimetry measurements of the uterine artery.	two weeks	Ultrasonographyc assessment of Doppler velocimetry measurements of the uterine artery.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026