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

Lo.Li.Pharma

Status

Withdrawn

Conditions

PCOS

Myo-inositol-resistance

Treatments

Dietary Supplement: Myo-inositol + folic a.

Dietary Supplement: Myo-inositol + folic a. + α-lactalbumin

Study type

Interventional

Funder types

Industry

Identifiers

NCT03667443

MILA

Details and patient eligibility

About

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

Full 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.

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion criteria

POCS women diagnosed using the Rotterdam Criteria

Exclusion criteria

Amenorrhea (3 months)
Other conditions causing ovulatory disorders and/or androgens hyper production such as: hyperprolactinemia, hypothyroidism, adrenal hyperplasia and Cushing syndrome
Hormonal and/or pharmacological treatments in the previous 3 months that could interfere with ovulation
Drastic changes in diet
Treatment with product containing Myo-inositol in the previous 3 months