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

University Magna Graecia

Status and phase: Completed; Phase 4

Conditions: Polycystic Ovary Syndrome; Pregnancy

Treatments: Drug: placebo alone; Drug: metformin plus placebo; Drug: placebo plus folic acid; Drug: Metformin plus folic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01115140

01/2010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnancy
• PCOS

Exclusion criteria

• Risk factors for pregnancy complications
• Severe obesity

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 5 patient groups, including a placebo group

Group A1

Active Comparator group

Description:

metformin plus placebo

Treatment:

Drug: metformin plus placebo

Group A2

Experimental group

Description:

metformin plus folic acid

Treatment:

Drug: Metformin plus folic acid

Group A3

Active Comparator group

Description:

placebo plus folic acid

Treatment:

Drug: placebo plus folic acid

Group A4

Placebo Comparator group

Description:

placebo cp, 2 cps daily

Treatment:

Drug: placebo alone

Group B

No Intervention group

Description:

observation