Department of Woman Health and Reproductive Medicine of Santo Spirito Hospital
Rome, Italy
NCT Number: NCT03422289
PCOS patients are initially treated with 2 g myo-inositol and 0.2 mg folic acid, two times per day by oral route, for three months. Among them, the subjects who have not ovulated despite this treatment are administered with 2g myo-inositol and 0.2 mg folic acid plus 50 mg α-lactalbumin for three months. Most of them improve and achieve ovulation. Therefore, the combination of α-lactalbumin with myo-inositol allows to get a significant result in the treatment of PCOS patients.
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Notify Me20 year–35 year
Female
Interventional
Not applicable
Rome, Italy
Polycystic ovary syndrome is a complex chronic condition inducing several related disorders, such as subfertility and pregnancy complications. So far myo-inositol, successfully used in PCOS, has not been always effective in all patients. Aiming at overcoming this drawback, we tested a new formulation with myo-inositol and α-lactalbumin, in consideration of the effects exerted by α-lactalbumin in favoring molecule passage among body compartments, and also in consideration of its anti-inflammatory activity.
Only PCOS patients, according to Rotterdam ESHRE-ASRM criteria, with anovulation and infertility > 1 year, were included in the study. Following a treatment with 2 g myo-inositol and 0.2 mg folic acid, a part of them are resistant and do not ovulate.
These non-responders to myo-inositol alone undergo the second phase of the study, receiving 2g myo-inositol and 0.2 mg folic acid plus 50 mg α-lactalbumin for three months. After this combined treatment, the majority of them ovulate, showing a hormone and lipid profile improvement. In addition, myo-inositol plasma levels at the end of the treatment are significantly higher than at baseline and comparable to those patients who respond positively to myo-inositol alone.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
this treatment is made in the first phase of the study for three months
this treatment is made in the second phase of the study and it has a new molecule added to the previous ones administered in the first phase of the study
Time frame: after three months of treatment
Ovulation was assessed using ultrasound examination on days 12, 14 and 20 of the cycle.
Time frame: after three months of treatment
Myo-inositol was dosed in plasma by means of gas chromatography-mass spectrometry
Lo.Li.Pharma s.r.l
Industry
Improved Effects of Myo-inositol in Association With Alpha-lactalbumin in PCOS Women
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