Improved Effects of MI Plus Alpha-LA in PCOS

NCT03422289 | Completed

• 1 other identifier: MI + alpha-LA
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Keywords

myo-inositol; alpha-lactalbumin; anovulation; infertility

Outcome Measures

Primary Outcomes (1)

• Restoration of ovulation

  Ovulation was assessed using ultrasound examination on days 12, 14 and 20 of the cycle.

  after three months of treatment

Secondary Outcomes (1)

• 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

Study Arms (2)

Myo-inositol + folic acid

EXPERIMENTAL

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

Dietary Supplement: myo-inositol plus folic acid

Myo-inositol + folic a. + α-lactalbumin

EXPERIMENTAL

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

Dietary Supplement: myo-inositol plus folic acid plus alpha-lactalbumin

Interventions

myo-inositol plus folic acid DIETARY_SUPPLEMENT

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

Myo-inositol + folic acid

myo-inositol plus folic acid plus alpha-lactalbumin 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

Myo-inositol + folic a. + α-lactalbumin

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients affected by PCOS according to Rotterdam ESHRE-ASRM criteria, with anovulation and infertility \> 1 year

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lo.Li.Pharma s.r.l: lead

Study Sites (1)

Department of Woman Health and Reproductive Medicine of Santo Spirito Hospital

Rome, Italy

Location

Related Publications (1)

• 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.

  PMID: 29747700 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Anovulation; Infertility

Interventions

Inositol; Folic Acid; Lactalbumin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Whey Proteins; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: February 5, 2018
• Study Start: November 2, 2016
• Primary Completion: October 12, 2017
• Study Completion: December 15, 2017
• Last Updated: February 6, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)