Alma Res Fertility Center
Rome, ITA, 00198, Italy
NCT Number: NCT06715527
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.
Looking for future studies?
Notify Me18 year–45 year
Female
Interventional
Not applicable
Rome, ITA, 00198, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Myo-inositol and D-chiro-inositol (40:1 ratio), 2 grams (twice a day) for three months
Other names: 40:1
Myo-inositol and D-chiro-inositol (3.6:1 ratio), 1.4 grams (once daily) for three months
Other names: 3.6:1
Time frame: From enrollment (T0) to the completion of the study at 3 months (T3M)
Number (%) of patients with regular menstrual cycle at the end of the study
Time frame: From enrollment (T0) to the completion of the study at 3 months (T3M)
Changes of serum hormonal levels (Progesterone; FSH; LH; Estradiol; Testosterone; Insulin)
Lo.Li.Pharma s.r.l
Industry
Treatment of Women With Different Phenotype of Polycystic Ovary Syndrome
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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