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

NCT ID: NCT03667443

Last Updated: 2025-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-13

Study Completion Date

2022-12-19

Brief Summary

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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

Detailed Description

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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.

Conditions

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PCOS Myo-inositol-resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Myo-inositol plus folic

Group Type ACTIVE_COMPARATOR

Myo-inositol + folic a.

Intervention Type DIETARY_SUPPLEMENT

3 months of treatment

Myo-inositol + folic a. + α-lactalbumin

Group Type ACTIVE_COMPARATOR

Myo-inositol + folic a. + α-lactalbumin

Intervention Type DIETARY_SUPPLEMENT

3 months of treatment

Interventions

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Myo-inositol + folic a. + α-lactalbumin

3 months of treatment

Intervention Type DIETARY_SUPPLEMENT

Myo-inositol + folic a.

3 months of treatment

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Inofolic HP Inofolic

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Lo.Li.Pharma s.r.l

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Aleksandrovska University Hospital

Sofia, , Bulgaria

Site Status

Countries

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Bulgaria

Other Identifiers

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MILA

Identifier Type: -

Identifier Source: org_study_id

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