Improved Effects of MI Plus Alpha-LA in PCOS

NCT ID: NCT03422289

Last Updated: 2018-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-02
• Study Completion Date: 2017-12-15

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.

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Myo-inositol + folic acid

2 g myo-inositol and 0.2 mg folic acid orally twice a day for three months, in order to induce ovulation.

Group Type: EXPERIMENTAL

myo-inositol plus folic acid

Intervention Type: DIETARY_SUPPLEMENT

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

Myo-inositol + folic a. + α-lactalbumin

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

Group Type: EXPERIMENTAL

myo-inositol plus folic acid plus alpha-lactalbumin

Intervention Type: 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

Interventions

myo-inositol plus folic acid

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

Intervention Type: DIETARY_SUPPLEMENT

myo-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

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Lo.Li.Pharma s.r.l

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Woman Health and Reproductive Medicine of Santo Spirito Hospital

Rome, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 29747700 (View on PubMed)

Other Identifiers

MI + alpha-LA

Identifier Type: -

Identifier Source: org_study_id