Improved Effects of MI Plus Alpha-LA in PCOS

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03422289
• Other study ID #: MI + alpha-LA
• Status: Completed
• Phase: N/A
• First received: January 10, 2018
• Last updated: February 5, 2018
• Start date: November 2, 2016
• Est. completion date: December 15, 2017

Study information

• Verified date: January 2018
• Source: Lo.Li.Pharma s.r.l
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 15, 2017
• Est. primary completion date: October 12, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Intervention

Dietary Supplement:
• myo-inositol plus folic acid
this treatment is made in the first phase of the study for three months
• 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

Locations

Country	Name	City	State
Italy	Department of Woman Health and Reproductive Medicine of Santo Spirito Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Lo.Li.Pharma s.r.l

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Restoration of ovulation	Ovulation was assessed using ultrasound examination on days 12, 14 and 20 of the cycle.	after three months of treatment
Secondary	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