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Improved Effects of MI Plus Alpha-LA in PCOS

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ClinicalTrials.gov Identifier: NCT03422289
Recruitment Status : Completed
First Posted : February 5, 2018
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Dietary Supplement: myo-inositol plus folic acid Dietary Supplement: myo-inositol plus folic acid plus alpha-lactalbumin Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
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
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improved Effects of Myo-inositol in Association With Alpha-lactalbumin in PCOS Women
Actual Study Start Date : November 2, 2016
Actual Primary Completion Date : October 12, 2017
Actual Study Completion Date : December 15, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Dietary Supplement: myo-inositol plus folic acid
this treatment is made in the first phase of the study for three months

Experimental: 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
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




Primary Outcome Measures :
  1. Restoration of ovulation [ Time Frame: after three months of treatment ]
    Ovulation was assessed using ultrasound examination on days 12, 14 and 20 of the cycle.


Secondary Outcome Measures :
  1. Increase of myo-inositol plasma levels after the treatment with myo-inositol plus alpha-lactalbumin compared to the levels at the baseline [ Time Frame: after three months of treatment ]
    Myo-inositol was dosed in plasma by means of gas chromatography-mass spectrometry



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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03422289


Locations
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Italy
Department of Woman Health and Reproductive Medicine of Santo Spirito Hospital
Rome, Italy
Sponsors and Collaborators
Lo.Li.Pharma s.r.l

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lo.Li.Pharma s.r.l
ClinicalTrials.gov Identifier: NCT03422289     History of Changes
Other Study ID Numbers: MI + alpha-LA
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lo.Li.Pharma s.r.l:
myo-inositol
alpha-lactalbumin
anovulation
infertility

Additional relevant MeSH terms:
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Inositol
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs