Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Menopause is the milestone of a more broaden condition that can last up to 10 years. The first menopausal symptoms usually appear around the age of 42 and are characterized by a gradual decline in thyroid and gonadal function with a progressive increase of plasmatic luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels.
Recent studies have shown that myo-inositol and melatonin play a major role in ovarian homeostasis. In particular, it has been demonstrated that myo-inositol and/or melatonin supplementation lead to an increase of oocyte quality.
Additional studies focused on postmenopausal women have shown that myo-inositol is able to ameliorate the metabolic syndrome that often affects these patients, thus reducing the risk of cardiovascular diseases (CVDs).
The aim of the present study is to evaluate whether myo-inositol and melatonin might play a positive role in regulating hormonal levels during menopausal onset.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myo+Mel | Experimental | Patients are treated with 2g of myo + 3mg of melatonin daily |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myo-Mel | Dietary Supplement |
| ||
| Placebo |
Inclusion Criteria:
Exclusion Criteria:
-
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AGUNCO | Recruiting | Rome | 00155 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18462730 | Background | Papaleo E, Unfer V, Baillargeon JP, Fusi F, Occhi F, De Santis L. RETRACTED: Myo-inositol may improve oocyte quality in intracytoplasmic sperm injection cycles. A prospective, controlled, randomized trial. Fertil Steril. 2009 May;91(5):1750-1754. doi: 10.1016/j.fertnstert.2008.01.088. Epub 2008 May 7. | |
| 20712264 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Rizzo P, Raffone E, Benedetto V. Effect of the treatment with myo-inositol plus folic acid plus melatonin in comparison with a treatment with myo-inositol plus folic acid on oocyte quality and pregnancy outcome in IVF cycles. A prospective, clinical trial. Eur Rev Med Pharmacol Sci. 2010 Jun;14(6):555-61. |
| 20811299 | Background | Giordano D, Corrado F, Santamaria A, Quattrone S, Pintaudi B, Di Benedetto A, D'Anna R. Effects of myo-inositol supplementation in postmenopausal women with metabolic syndrome: a perspective, randomized, placebo-controlled study. Menopause. 2011 Jan;18(1):102-4. doi: 10.1097/gme.0b013e3181e8e1b1. |
| 18804205 | Background | Tamura H, Nakamura Y, Korkmaz A, Manchester LC, Tan DX, Sugino N, Reiter RJ. Melatonin and the ovary: physiological and pathophysiological implications. Fertil Steril. 2009 Jul;92(1):328-43. doi: 10.1016/j.fertnstert.2008.05.016. Epub 2008 Sep 18. |
| 18339123 | Background | Tamura H, Takasaki A, Miwa I, Taniguchi K, Maekawa R, Asada H, Taketani T, Matsuoka A, Yamagata Y, Shimamura K, Morioka H, Ishikawa H, Reiter RJ, Sugino N. Oxidative stress impairs oocyte quality and melatonin protects oocytes from free radical damage and improves fertilization rate. J Pineal Res. 2008 Apr;44(3):280-7. doi: 10.1111/j.1600-079X.2007.00524.x. |