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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A1 | Active Comparator | metformin plus placebo |
|
| Group A2 | Experimental | metformin plus folic acid |
|
| Group A3 | Active Comparator | placebo plus folic acid |
|
| Group A4 | Placebo Comparator | placebo cp, 2 cps daily |
|
| Group B | No Intervention | observation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| metformin plus placebo | Drug | metformin 850 mg cp, 2 cps daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Trophoblastic invasion. | Istologic evaluation of trophoblastic ivasion, | two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Doppler velocimetry measurements of the uterine artery. | Ultrasonographyc assessment of Doppler velocimetry measurements of the uterine artery. | two weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fulvio Zullo, MD | Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro | Study Chair |
| Stefano Palomba, MD | Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Pugliese" Hospital | Catanzaro | Catanzaro | 88100 | Italy |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D011622 |
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| Metformin plus folic acid |
| Drug |
metformin 850 mg cp, 2 cps daily plus folic acid 0.4 mg daily |
|
| placebo plus folic acid | Drug | Placebo 1 cp daily plus folic acid 0.4 mg daily |
|
| placebo alone | Drug | placebo cp, 2 cps daily |
|
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |