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In this study, female patients diagnosed with polycystic ovary syndrome (PCOS) will be enrolled. In particular, those with elevated testosterone or with clinical signs of hyperandrogenism, along with menstrual cycle alterations and/or polycystic ovary morphology at ultrasound, will be included in the study.
Current treatments for PCOS include insulin sensitizers (such as metformin) and hormonal contraceptives. However, they are not devoid of side effects or may not be well tolerated, often leading to therapy discontinuation. Inositol represents a valid alternative to standard treatments, as it serves both as insulin sensitizer and as second messenger of FSH in the ovaries, thus regulating glucose metabolism and supporting ovarian function. The presence of two inositol isomers, namely myo-inositol and D-chiro-inositol, in defined ratios in human tissues suggests that supplementation with both would be ideal. Despite numerous evidence available, the ratio that gives the best clinical results is still debated.
In the present clinical trial, patients will be given a dietary supplement containing myo-inositol and D-chiro-inositol in two ratios (either 40:1 or 3.6:1, respectively) for three months. Restoration of regular menstrual cycle and of hormonal status will be the primary goal of the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Women with PCOS under oral supplementation with myo-inositol and D-chiro-inositol in 40:1 ratio |
|
| Comparator | Active Comparator | Women with PCOS under oral supplementation with myo-inositol and D-chiro-inositol in 3.6:1 ratio |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myo-Inositol and D-Chiro-Inositol (40:1) | Dietary Supplement | Myo-inositol and D-chiro-inositol (40:1 ratio), 2 grams (twice a day) for three months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Restoration of regular menstrual cycle | Number (%) of patients with regular menstrual cycle at the end of the study | From enrollment (T0) to the completion of the study at 3 months (T3M) |
| Measure | Description | Time Frame |
|---|---|---|
| Hormonal status | Changes of serum hormonal levels (Progesterone; FSH; LH; Estradiol; Testosterone; Insulin) | From enrollment (T0) to the completion of the study at 3 months (T3M) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alma Res Fertility Center | Rome | ITA | 00198 | Italy |
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| Myo-Inositol and D-Chiro-Inositol (3.6:1) | Dietary Supplement | Myo-inositol and D-chiro-inositol (3.6:1 ratio), 1.4 grams (once daily) for three months |
|
|
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | 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 |
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| ID | Term |
|---|---|
| D007294 | Inositol |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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