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Previous studies have demonstrated that Myo-inositol is capable of restoring spontaneous ovarian activity, and consequently fertility, in most patients with PCOS. The aim of our study is to investigate the role of folic acid conteined in the inositol preparation. The study group included 50 patients, randomly allocated to subgroup A (myo-inositol 1500 gr) and subgroup B (myo-inositol 2000 gr + folic acid 200 mcg). The investigation include menstrual pattern and hirsutism score evaluation, hormonal assays, oral glucose tolerance test, euglycemic hyperinsulinaemic clamp and lipide profile at baseline and after six months of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| myo-inositol 1500 gr | Active Comparator | 6 months treatment with myo-inositol 1500 gr |
|
| myo-inositol 2000gr + folic acid 200 mcg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| myo-inositol 1500 gr | Drug |
| ||
| myo-inositol 2000 gr + folic acid 200 mcg |
| Measure | Description | Time Frame |
|---|---|---|
| number of cycles in six months of therapy | We'll estimate the efficacy of the two treatments on the ovarian function and menstrual pattern. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| effects on oral glucose tollerance test | six months | |
| effects on hoormonal assay | 6 months | |
| effects oon lipide profile |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic University of Sacred Heart | Rome | 00168 | Italy |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D006628 | Hirsutism |
| D008599 | Menstruation Disturbances |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Drug |
|
| 6 months |
| 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 |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014770 | Virilism |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| D006571 | Heterocyclic Compounds |