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Myo-inositol Plus Alpha-lactalbumin in PCOS Myo-inositol-resistant Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03667443
Recruitment Status : Not yet recruiting
First Posted : September 12, 2018
Last Update Posted : September 14, 2018
Information provided by (Responsible Party):
Lo.Li.Pharma s.r.l

Brief Summary:
The investigator's aim is to evaluate if the combination of myo-inositol and alpha-lactalbumin can overcome the resistance to myo-inositol in PCOS patients

Condition or disease Intervention/treatment Phase
PCOS Myo-inositol-resistance Dietary Supplement: Myo-inositol + folic a. + α-lactalbumin Dietary Supplement: Myo-inositol + folic a. Not Applicable

Detailed Description:
In this study, the investigators expect about 30% of the PCOS patients enrolled to be resistant to Myo-inositol treatment for ovulation induction, probably due to the presence of malabsorption caused by gut dysbiosis. The most recent evidence proposes dysbiosis and related chronic low-grade inflammation as the new DOGMA behind PCOS pathogenesis. In this regard, the recent findings on alpha-lactalbumin reports its effect in improving the absorption of different nutrients including myo-inositol as well as a crucial factor for reducing inflammation. Furthermore, this whey protein is well known for its effect as trophic agent for gastrointestinal flora in infants. For all these reasons, the investigators expect that the treatment with Inofolic HP (Myo-inositol and alpha-lactalbumin) will get an efficacy 20-25% higher than the treatment with inofolic.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Myo-inositol Plus Alpha-lactalbumin in Ovulation Induction of PCOS Myo-inositol-resistant Patients
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Inositol

Arm Intervention/treatment
Active Comparator: Myo-inositol plus folic Dietary Supplement: Myo-inositol + folic a.
3 months of treatment
Other Name: Inofolic

Active Comparator: Myo-inositol + folic a. + α-lactalbumin Dietary Supplement: Myo-inositol + folic a. + α-lactalbumin
3 months of treatment
Other Name: Inofolic HP

Primary Outcome Measures :
  1. ovulation induction [ Time Frame: after three months of treatment ]
    Ovulation indaction will by evaluated through ultrasound sonography

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • POCS women diagnosed using the Rotterdam Criteria

Exclusion Criteria:

  • Amenorrhea (3 months)
  • Other conditions causing ovulatory disorders and/or androgens hyper production such as: hyperprolactinemia, hypothyroidism, adrenal hyperplasia and Cushing syndrome
  • Hormonal and/or pharmacological treatments in the previous 3 months that could interfere with ovulation
  • Drastic changes in diet
  • Treatment with product containing Myo-inositol in the previous 3 months

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Responsible Party: Lo.Li.Pharma s.r.l Identifier: NCT03667443     History of Changes
Other Study ID Numbers: MILA
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Lo.Li.Pharma s.r.l:
polycystic ovary syndrome

Additional relevant MeSH terms:
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Vitamin B Complex
Growth Substances
Physiological Effects of Drugs