Treatment of Women with PCOS of Phenotype D

Not Applicable

Recruiting

• Conditions: PCOS (Polycystic Ovary Syndrome)

• Registration Number: NCT06639698
• Lead Sponsor: Lo.Li.Pharma s.r.l

Brief Summary

In this study, female patients diagnosed with PCOS of phenotype D will be enrolled. They generally display the following characteristics: menstrual cycle alterations; polycystic ovary morphology at ultrasound; normal blood levels of androgen, particularly testosterone; no signs of clinical hyperandrogenism.

Current treatments for this condition include insulin sensitizers (such as metformin) and hormonal contraceptives. However, this specific phenotype of PCOS do not feature metabolic or hormonal alterations, and the efficacy of these treatments has lately been questioned.

In the present clinical trial, patients will be given a dietary supplement containing Dioscorea extract (source of Diosgenin, a natural analog of progesterone), vitamin D and alpha-lactalbumin for six month. Restoration of regular menstrual cycle and physiological ultrasound appearance of the ovaries will be the primary goal of the intervention.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-11
• Study First Submitted QC: 2024-10-11
• Study Start: 2024-10-14
• Study First Posted: 2024-10-15
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-17
• Primary Completion: 2025-05-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Diagnosis of PCOS of phenotype D, according to the Rotterdam Criteria and the EGOI-PCOS Criteria

Exclusion Criteria

• Diagnosis of PCOS of phenotype A, B or C, according to the Rotterdam Criteria and the EGOI-PCOS Criteria
• Hormonal treatments;
• Treatments with inositol or other insulin sensitizers (such as metformin);
• Insulin resistance or pre-diabetes condition
• BMI > 30
• Endocrinological alterations
• Chronic pharmacological therapies
• Major pathological conditions (e.g. tumors or autoimmune diseases)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Restoration of regular menstrual cycle	From enrollment (T0) to the completion of the study at 6 months (T6M)	Restoration of regular menstrual cycle will be assessed counting the days between two subsequent menstrual cycles, using a menstrual diary updated by the patients

Secondary Outcome Measures

Name	Time	Method
Restoration of physiological appearance of the ovaries at ultrasound	From enrollment (T0) to the completion of the study at 6 months (T6M)	Reduction of the ultrasonography count of arrested ovarian follicles

Trial Locations

Locations (1)

Alma Res Fertility Center; 🇮🇹 Rome, ITA, Italy