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OpenTrials
Completed

NCT Number: NCT03422289

Improved Effects of MI Plus Alpha-LA in PCOS

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.

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Key information

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Woman Health and Reproductive Medicine of Santo Spirito Hospital

Rome, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients affected by PCOS according to Rotterdam ESHRE-ASRM criteria, with anovulation and infertility > 1 year

Exclusion criteria

  • presence of other conditions causing ovulatory dysfunction, such as hyperprolactinemia or hypothyroidism, or androgen excess, such as adrenal hyperplasia or Cushing's syndrome, and also in the case of intake of other drugs that can potentially influence the ovulation.

Treatment and study plan

myo-inositol plus folic acid

Dietary Supplement

this treatment is made in the first phase of the study for three months

myo-inositol plus folic acid plus alpha-lactalbumin

Dietary Supplement

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

Primary outcomes

  1. Restoration of ovulation

    Time frame: after three months of treatment

    Ovulation was assessed using ultrasound examination on days 12, 14 and 20 of the cycle.

Secondary outcomes

  1. Increase of myo-inositol plasma levels after the treatment with myo-inositol plus alpha-lactalbumin compared to the levels at the baseline

    Time frame: after three months of treatment

    Myo-inositol was dosed in plasma by means of gas chromatography-mass spectrometry

Sponsors and collaborators

Lead sponsor

Lo.Li.Pharma s.r.l

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 5, 2018
Registry last updated
Feb 6, 2018

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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