Improved Effects of MI Plus Alpha-LA in PCOS

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Dietary Supplement: myo-inositol plus folic acid
* Dietary Supplement: myo-inositol plus folic acid plus alpha-lactalbumin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: All the patients were given orally Inofolic® (Lo.Li. Pharma, Rome, Italy), containing 2 g myo-inositol and 0.2 mg folic acid twice a day for three months, in order to induce ovulation. Then, non-responder partecipants were administered orally with 2 g myo-inositol plus 50 mg α-lactalbumin, twice a day for three months
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Myo-inositol + folic acid<br>2 g myo-inositol and 0.2 mg folic acid orally twice a day for three months, in order to induce ovulation. | Dietary Supplement: myo-inositol plus folic acid<br>* this treatment is made in the first phase of the study for three months<br>|
| Experimental: Myo-inositol + folic a. + α-lactalbumin<br>2 g myo-inositol and 0.2 mg folic acid plus 50 mg α-lactalbumin, twice a day for three months in order to test if α-lactalbumin addition allows to induce ovulation | Dietary Supplement: myo-inositol plus folic acid plus alpha-lactalbumin<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restoration of ovulation | Ovulation was assessed using ultrasound examination on days 12, 14 and 20 of the cycle. | after three months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase of myo-inositol plasma levels after the treatment with myo-inositol plus alpha-lactalbumin compared to the levels at the baseline | Myo-inositol was dosed in plasma by means of gas chromatography-mass spectrometry | after three months of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myo-inositol, alpha-lactalbumin, anovulation, infertility