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

Study Overview
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Brief Summary
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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: What are the effects of the tested regimens on Body mass index (BMI)? What are the effects of the tested regimens on hormonal status? What are the effects of the tested regimens on uterine artery resistive index ? What are the effects of the tested regimens on some inflammatory markers? Participants will be separated into two groups: Group 1 (M): 25 Patients, Received Metformin 500mg per oral twice daily for 90 days duration. Group 2 (D): 25 Patients, Received Dostinex (Pergolin) 0.5 mg per oral (single dose per/week). 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.

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

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Drug: Metformin Hydrochloride 500 MG
* Drug: Cabergoline 0.5 MG
* Drug: Metformin Hydrochloride 500 MG + Cabergoline 0.5 MG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 (M)<br>25 Patients administered Metformin (Glucophage) Tablets of 500 mg per oral twice daily for 90 days duration. | Drug: Metformin Hydrochloride 500 MG<br>* Brand name: (Glucophage) Tablets per oral / Twice daily / 90 days duration<br>|
| Active Comparator: Group 2 (D)<br>25 Patients administered Cabergoline (Pergoline) Tablets of 0.5 mg dose per oral once weekly for 90 days duration. | Drug: Cabergoline 0.5 MG<br>* Brand name: (Pergoline) Tablets per oral / single dose per week / 90 days duration<br>|
| Active Comparator: Group 3 (MD)<br>25 Patients administered Metformin (Glucophage) Tablets of 500 mg per oral twice daily and Cabergoline (Pergoline) Tablets of 0.5 mg dose per oral once weekly for 90 days duration. | Drug: Metformin Hydrochloride 500 MG + Cabergoline 0.5 MG<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index (BMI) | Measured in Kg/m² as a part of hormone status changes analysis | at Baseline, and after 90 days | 
| Serum Anti-Müllerian hormone (AMH) | Measured in ng/mL as a part of hormone status changes analysis | at Baseline, and after 90 days | 
| Serum Testosterone | Measured in ng/mL as a part of hormone status changes analysis | at Baseline, and after 90 days | 
| Serum Luteinizing hormone (LH) | Measured in mIU/mL as a part of hormone status changes analysis | at Baseline, and after 90 days | 
| Serum Follicular Stimulating Hormone (FSH) | Measured in mIU/mL as a part of hormone status changes analysis | at Baseline, and after 90 days | 
| Serum Prolactin (PRL) | Measured in ng/mL as a part of hormone status changes analysis | at Baseline, and after 90 days | 
| Mean number of dominant follicles (DF) | Calculated by ultrasonography as a part of the ultrasonic analysis | at Baseline, and after 90 days | 
| Mean Resistive Index (RI) | Calculated by ultrasonography as a part of the ultrasonic analysis | at Baseline, and after 90 days | 
| Serum Anti-GAD antibody | Measured in ng/mL as a part of inflammatory markers analysis | at Baseline, and after 90 days | 
| Serum Anti-GnRH antibody | Measured in pg/mL as a part of inflammatory markers analysis | at Baseline, and after 90 days | 
| Serum IL-18 Level | Measured in pg/mL as a part of inflammatory markers analysis | at Baseline, and after 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polycystic ovary syndrom, hormones, endometrial resistive index, metformin, Cabergoline