Improved Effects of MI Plus Alpha-LA in PCOS

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Dietary Supplement: myo-inositol plus folic acid; Dietary Supplement: myo-inositol plus folic acid plus alpha-lactalbumin

• Registration Number: NCT03422289
• Lead Sponsor: Lo.Li.Pharma s.r.l

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.

Study Timeline

• Study Start: 2016-11-02
• Primary Completion: 2017-10-12
• Study Completion: 2017-12-15
• Status Verified: 2018-01
• Study First Submitted: 2018-01-10
• Study First Submitted QC: 2018-02-02
• Study First Posted: 2018-02-05
• Last Update Submitted: 2018-02-05
• Last Update Posted: 2018-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 37

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Myo-inositol + folic acid	myo-inositol plus folic acid	2 g myo-inositol and 0.2 mg folic acid orally twice a day for three months, in order to induce ovulation.
Myo-inositol + folic a. + α-lactalbumin	myo-inositol plus folic acid plus alpha-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

Primary Outcome Measures

Name	Time	Method
Restoration of ovulation	after three months of treatment	Ovulation was assessed using ultrasound examination on days 12, 14 and 20 of the cycle.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Woman Health and Reproductive Medicine of Santo Spirito Hospital; 🇮🇹 Rome, Italy