Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS

Al-Rasheed University College75 enrolled

Overview

The goal of this interventional Randomized clinical is to compare the effect of Metformin alone, Cabergoline alone and Metformin and Cabergoline in combination in a sample of Iraqi female patients with polycystic ovary syndrome. The main questions to answer are: 1. What are the effects of the tested regimens on Body mass index (BMI)? 2. What are the effects of the tested regimens on hormonal status? 3. What are the effects of the tested regimens on uterine artery resistive index ? 4. What are the effects of the tested regimens on some inflammatory markers? Participants will be separated into two groups: 1. Group 1 (M): 25 Patients, Received Metformin 500mg per oral twice daily for 90 days duration. 2. Group 2 (D): 25 Patients, Received Dostinex (Pergolin) 0.5 mg per oral (single dose per/week). 3. Group 3 (MD): 25 Pateins, Received metformin 500 mg per oral twice daily for 90 days duration and Dostinex (Pergolin) as 0.5 mg per oral (single dose per/week). Researchers will compare Group 1 (M), Group 2 (D), Group 3 (MD) to observe the effect of the tested treatment regimens on Body Mass Index, Hormonal status, uterine artery resistive index, and some inflammatory markers that are IL-18, Anti-GAD Antibody and GnRH Antibody.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Polycystic Ovary Syndrome

Metformin Hydrochloride 500 MGDRUG

Brand name: (Glucophage) Tablets per oral / Twice daily / 90 days duration

Cabergoline 0.5 MGDRUG

Brand name: (Pergoline) Tablets per oral / single dose per week / 90 days duration

Metformin Hydrochloride 500 MG + Cabergoline 0.5 MGDRUG

Metformin Brand name: (Glucophage) Tablets per oral / Twice daily / 90 days duration Cabergoline Brand name: (Pergoline) Tablets per oral / single dose per week / 90 days duration

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 - 40 years * Diagnosed with Polycystic Ovarian Syndrome based on Rotterdam criteria * Body Mass Index (BMI) \< 40 Kg/m² Exclusion Criteria: * Age less than 18 years or more than 40 years * Co-morbid conditions including (diabetes mellitus, essential hypertension, and thyroid disease) * Patients planning for conception. * Body Mass Index \> 40 Kg/m²

Locations (1)

Maternity and Pediatric Teaching Hospital

Al Qādisīyah, Al-Qādisiyyah Governorate, Iraq