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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03667443

Enrollment

Registered

2018-09-12

Start date

2022-06-13

Completion date

2022-12-19

Last updated

2025-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myo-inositol-resistance, PCOS

Keywords

myo-inositol, alpha-lactalbumin, polycystic ovary syndrome, anovulation, infertility

Brief 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.

Interventions

DIETARY_SUPPLEMENTMyo-inositol + folic a. + α-lactalbumin

3 months of treatment

DIETARY_SUPPLEMENTMyo-inositol + folic a.

3 months of treatment

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

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

Design outcomes

Primary

Measure	Time frame	Description
ovulation induction	after three months of treatment	Ovulation indaction will by evaluated through ultrasound sonography

Countries

Bulgaria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026