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OpenTrials
Completed

NCT Number: NCT03667443

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Myo-inositol + folic a. + α-lactalbumin

Dietary Supplement

3 months of treatment

Other names: Inofolic HP

Myo-inositol + folic a.

Dietary Supplement

3 months of treatment

Other names: Inofolic

Primary outcomes

  1. ovulation induction

    Time frame: after three months of treatment

    Ovulation indaction will by evaluated through ultrasound sonography

Sponsors and collaborators

Lead sponsor

Lo.Li.Pharma s.r.l

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 12, 2018
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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