NCT03667443

Myo-inositol Plus Alpha-lactalbumin in PCOS Myo-inositol-resistant Patients

The Effects of Myo-inositol Plus Alpha-lactalbumin in Ovulation Induction of PCOS Myo-inositol-resistant Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Lo.Li.Pharma s.r.l · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

The investigator's aim is to evaluate if the combination of myo-inositol and alpha-lactalbumin can overcome the resistance to myo-inositol in PCOS patients

Detailed description

In this study, the investigators expect about 30% of the PCOS patients enrolled to be resistant to Myo-inositol treatment for ovulation induction, probably due to the presence of malabsorption caused by gut dysbiosis. The most recent evidence proposes dysbiosis and related chronic low-grade inflammation as the new DOGMA behind PCOS pathogenesis. In this regard, the recent findings on alpha-lactalbumin reports its effect in improving the absorption of different nutrients including myo-inositol as well as a crucial factor for reducing inflammation. Furthermore, this whey protein is well known for its effect as trophic agent for gastrointestinal flora in infants. For all these reasons, the investigators expect that the treatment with Inofolic HP (Myo-inositol and alpha-lactalbumin) will get an efficacy 20-25% higher than the treatment with inofolic.

Conditions

• PCOS
• Myo-inositol-resistance

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Myo-inositol + folic a. + α-lactalbumin	3 months of treatment
DIETARY_SUPPLEMENT	Myo-inositol + folic a.	3 months of treatment

Timeline

• Start date: 2022-06-13
• Primary completion: 2022-10-26
• Completion: 2022-12-19
• First posted: 2018-09-12
• Last updated: 2025-07-11

Locations

1 site across 1 country: Bulgaria