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

Not Applicable

Withdrawn

• Conditions: Myo-inositol-resistance; PCOS
• Interventions: Dietary Supplement: Myo-inositol + folic a.; Dietary Supplement: Myo-inositol + folic a. + α-lactalbumin

• Registration Number: NCT03667443
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2018-08-01
• Study First Submitted QC: 2018-09-11
• Study First Posted: 2018-09-12
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-05
• Study Start: 2022-04-11
• Last Update Posted: 2022-04-13
• Primary Completion: 2023-01-01
• Study Completion: 2023-02-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Myo-inositol plus folic	Myo-inositol + folic a.	-
Myo-inositol + folic a. + α-lactalbumin	Myo-inositol + folic a. + α-lactalbumin	-

Primary Outcome Measures

Name	Time	Method
ovulation induction	after three months of treatment	Ovulation indaction will by evaluated through ultrasound sonography