NCT03422289

Improved Effects of MI Plus Alpha-LA in PCOS

Improved Effects of Myo-inositol in Association With Alpha-lactalbumin in PCOS Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Lo.Li.Pharma s.r.l · Industry
• Sex: Female
• Age: 20 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Polycystic Ovary Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	myo-inositol plus folic acid	this treatment is made in the first phase of the study for three months
DIETARY_SUPPLEMENT	myo-inositol plus folic acid plus alpha-lactalbumin	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

Timeline

• Start date: 2016-11-02
• Primary completion: 2017-10-12
• Completion: 2017-12-15
• First posted: 2018-02-05
• Last updated: 2018-02-06

Locations

1 site across 1 country: Italy