Insulin Sensitizers Role in Control of PCOS Vicious Cycle.

Phase 1

Completed

• Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
• Interventions: Drug: Combination of Metformin hydrochloride and MI/DCI; Drug: Metformin Hydrochloride

• Registration Number: NCT06170463
• Lead Sponsor: Zagazig University

Brief Summary

PCOS is a common and complex disease affecting women of reproductive age. It is characterized by its complex pathological symptoms and mechanisms resulting in endocrine and metabolic dysfunction. PCOS is highly associated with various metabolic and endocrinal disorders. Metformin is mainly used for its glucose-lowering effects for treatment and prevention of type-2 diabetes mellitus (DM), gestational DM, and PCOS. Myo-inositol (MI) protects against MAFLD through reduction of hepatic accumulation of triglycerides.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-01
• Primary Completion: 2023-03-01
• Study Completion: 2023-04-15
• Status Verified: 2023-12
• Study First Submitted: 2023-12-06
• Study First Submitted QC: 2023-12-06
• Last Update Submitted: 2023-12-13
• Study First Posted: 2023-12-14
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 210

Inclusion Criteria

• Age;
• Residence;
• level of education & type of work;
• Marital and fertility statuses, and if infertility was the main complaint;
• Presence of risk factors as sedentary lifestyle;
• Emotional stress and family history of PCOS;
• Obesity-related medical disorders especially DM or MAFLD;
• History of previous treatment for PCOS and its outcomes;
• Menstrual pattern such as infrequent menstrual periods.

Exclusion Criteria

• Women had other manifestations of metabolic syndrome:
• Cardiac manifestations of PCOS;
• Maintained on other therapies or prepared for /received laparoscopic intervention for PCOS;
• Receiving scheduled exercise, lipid-lowering therapies, or maintained on diabetogenic drugs for any other indications;
• Had morbid obesity with body mass index (BMI) >35 kg/m2;
• Causes other than PCOS for infertility, manifest DM, hepatic or pancreatic diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MM Group	Combination of Metformin hydrochloride and MI/DCI	-
Met Group	Metformin Hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Improvement of mensural pattern	6 months	The Evaluation of the success rate of the applied regimens to gain mensural regular pattern in PCOS Women

Trial Locations

Locations (1)

Zagazig university; 🇪🇬 Zagazig, Ash Sharqia Governorate, Egypt