Clinical trial NCT03422289: Improved Effects of MI Plus Alpha-LA in PCOS
Official title: Improved Effects of Myo-inositol in Association With Alpha-lactalbumin in PCOS Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: myo-inositol
alpha-lactalbumin
anovulation
infertility
Lead sponsor: Lo.Li.Pharma s.r.l
Sponsor class: INDUSTRY
First posted: 2018-02-05
Enrollment: 37
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Restoration of ovulation
timeFrame: after three months of treatment
Secondary outcomes:
measure: Increase of myo-inositol plasma levels after the treatment with myo-inositol plus alpha-lactalbumin compared to the levels at the baseline
timeFrame: after three months of treatment
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Department of Woman Health and Reproductive Medicine of Santo Spirito Hospital
Study officials:
References:
citation: Montanino Oliva M, Buonomo G, Calcagno M, Unfer V. Effects of myo-inositol plus alpha-lactalbumin in myo-inositol-resistant PCOS women. J Ovarian Res. 2018 May 10;11(1):38. doi: 10.1186/s13048-018-0411-2.