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

Sponsor
Lo.Li.Pharma s.r.l (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT03667443
Collaborator
(none)
0
Enrollment
2
Arms
9.7
Anticipated Duration (Months)

Study Details

Study Description

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
  • Dietary Supplement: Myo-inositol + folic a. + α-lactalbumin
  • Dietary Supplement: Myo-inositol + folic a.
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 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
Anticipated Study Start Date :
Apr 11, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Myo-inositol plus folic

Dietary Supplement: Myo-inositol + folic a.
3 months of treatment
Other Names:
  • Inofolic

    		•
    Active Comparator: Myo-inositol + folic a. + α-lactalbumin

    Dietary Supplement: Myo-inositol + folic a. + α-lactalbumin
    3 months of treatment
    Other Names:
  • Inofolic HP

    		•

    Outcome Measures

    Primary Outcome Measures

    1. ovulation induction [after three months of treatment]

      Ovulation indaction will by evaluated through ultrasound sonography

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Lo.Li.Pharma s.r.l

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lo.Li.Pharma s.r.l
    ClinicalTrials.gov Identifier:
    NCT03667443
    Other Study ID Numbers:
    • MILA
    First Posted:
    Sep 12, 2018
    Last Update Posted:
    Apr 13, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    myo-inositol
    alpha-lactalbumin
    polycystic ovary syndrome
    anovulation
    infertility
    Additional relevant MeSH terms:
    Inositol

    Study Results

    No Results Posted as of Apr 13, 2022