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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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PCOS, Myo-inositol-resistance

Intervention / Treatment
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* Dietary Supplement: Myo-inositol + folic a. + α-lactalbumin
* Dietary Supplement: Myo-inositol + folic a.


Participation Criteria
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Eligibility Criteria
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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
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: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Myo-inositol plus folic<br> | Dietary Supplement: Myo-inositol + folic a.<br>* 3 months of treatment<br>* Other names: Inofolic;|
| Active Comparator: Myo-inositol + folic a. + α-lactalbumin<br> | Dietary Supplement: Myo-inositol + folic a. + α-lactalbumin<br>* 3 months of treatment<br>* Other names: Inofolic HP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ovulation induction | Ovulation indaction will by evaluated through ultrasound sonography | after three months of treatment | 

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