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
|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|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|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)|
|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|
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
- 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.
- 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
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
|Department of Woman Health and Reproductive Medicine of Santo Spirito Hospital|