Treatment of Women With Hyperandrogenic PCOS With Two Different Ratios of Myo-inositol:D-chiro-inositol: A Comparison

Last updated: April 7, 2025
Sponsor: Lo.Li.Pharma s.r.l
Overall Status: Completed

Phase

N/A

Condition

Polycystic Ovarian Syndrome

Reproductive Health

Treatment

Myo-Inositol and D-Chiro-Inositol (3.6:1)

Myo-Inositol and D-Chiro-Inositol (40:1)

Clinical Study ID

NCT06715527
Ino-ratio_2024
  • Ages 18-45
  • Female

Study Summary

In this study, female patients diagnosed with polycystic ovary syndrome (PCOS) will be enrolled. In particular, those with elevated testosterone or with clinical signs of hyperandrogenism, along with menstrual cycle alterations and/or polycystic ovary morphology at ultrasound, will be included in the study.

Current treatments for PCOS include insulin sensitizers (such as metformin) and hormonal contraceptives. However, they are not devoid of side effects or may not be well tolerated, often leading to therapy discontinuation. Inositol represents a valid alternative to standard treatments, as it serves both as insulin sensitizer and as second messenger of FSH in the ovaries, thus regulating glucose metabolism and supporting ovarian function. The presence of two inositol isomers, namely myo-inositol and D-chiro-inositol, in defined ratios in human tissues suggests that supplementation with both would be ideal. Despite numerous evidence available, the ratio that gives the best clinical results is still debated.

In the present clinical trial, patients will be given a dietary supplement containing myo-inositol and D-chiro-inositol in two ratios (either 40:1 or 3.6:1, respectively) for three months. Restoration of regular menstrual cycle and of hormonal status will be the primary goal of the intervention.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • PCOS according to the Rotterdam Criteria

  • Clinical or biochemical hyperandrogenism

Exclusion

Exclusion Criteria:

  • other causes of ovulatory disfunction (e.g., hyperprolactinemia or hypothyroidism)

  • other causes of hyperandrogenism (e.g., adrenal hyperplasia or Cushing's syndrome)

  • use of medications that influence ovulation

  • hormonal treatments

  • chronic pharmacological therapies

  • use of inositol-containing supplements

  • regular consumption of inositol-enriched food

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Myo-Inositol and D-Chiro-Inositol (3.6:1)
Phase:
Study Start date:
November 01, 2024
Estimated Completion Date:
March 14, 2025

Connect with a study center

  • Alma Res Fertility Center

    Rome, ITA 00198
    Italy

    Site Not Available

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