Polycystic Ovary Syndrome
Conditions
Keywords
myo-inositol, alpha-lactalbumin, anovulation, infertility
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTmyo-inositol plus folic acid
this treatment is made in the first phase of the study for three months
DIETARY_SUPPLEMENTmyo-inositol plus folic acid plus alpha-lactalbumin
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
Sponsors
Lo.Li.Pharma s.r.l
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Restoration of ovulation | after three months of treatment | Ovulation was assessed using ultrasound examination on days 12, 14 and 20 of the cycle. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Increase of myo-inositol plasma levels after the treatment with myo-inositol plus alpha-lactalbumin compared to the levels at the baseline | after three months of treatment | Myo-inositol was dosed in plasma by means of gas chromatography-mass spectrometry |
Countries
Italy
Outcome results
None listed