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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pregnancy, Polycystic Ovary Syndrome

Intervention / Treatment
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* Drug: metformin plus placebo
* Drug: Metformin plus folic acid
* Drug: placebo plus folic acid
* Drug: placebo alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnancy PCOS Exclusion Criteria: Risk factors for pregnancy complications Severe obesity

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A1<br>metformin plus placebo | Drug: metformin plus placebo<br>* metformin 850 mg cp, 2 cps daily<br>|
| Experimental: Group A2<br>metformin plus folic acid | Drug: Metformin plus folic acid<br>* metformin 850 mg cp, 2 cps daily plus folic acid 0.4 mg daily<br>|
| Active Comparator: Group A3<br>placebo plus folic acid | Drug: placebo plus folic acid<br>* Placebo 1 cp daily plus folic acid 0.4 mg daily<br>|
| Placebo Comparator: Group A4<br>placebo cp, 2 cps daily | Drug: placebo alone<br>* placebo cp, 2 cps daily<br>|
| No Intervention: Group B<br>observation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trophoblastic invasion. | Istologic evaluation of trophoblastic ivasion, | two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Doppler velocimetry measurements of the uterine artery. | Ultrasonographyc assessment of Doppler velocimetry measurements of the uterine artery. | two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Folate, Metformin, PCOS, Pregnancy, Trophoblastic invasion, Uterine artery velocimetry