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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

ClinicalTrials.gov · COMPLETED, 2023

75 participants

Abstract

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.

Conditions: Polycystic Ovary Syndrome.

Primary outcome: Body Mass Index (BMI); Serum Anti-Müllerian hormone (AMH); Serum Testosterone; Serum Luteinizing hormone (LH); Serum Follicular Stimulating Hormone (FSH); Serum Prolactin (PRL); Mean number of dominant…

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 75 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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