Treatment of Women With Different Phenotype of Polycystic Ovary Syndrome

Status: Completed
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• PCOS according to the Rotterdam Criteria

• Clinical or biochemical hyperandrogenism

Locations
Other Locations
Italy
Alma Res Fertility Center
Rome
Time Frame
Start Date: 2024-11-01
Completion Date: 2025-03-14
Participants
Target number of participants: 30
Treatments
Experimental: Treatment
Women with PCOS under oral supplementation with myo-inositol and D-chiro-inositol in 40:1 ratio
Active_comparator: Comparator
Women with PCOS under oral supplementation with myo-inositol and D-chiro-inositol in 3.6:1 ratio
Sponsors
Leads: Lo.Li.Pharma s.r.l

This content was sourced from clinicaltrials.gov