Polycystic Ovary Syndrome
Conditions
Keywords
polycystic ovary syndrom, hormones, endometrial resistive index, metformin, Cabergoline
Brief summary
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.
Interventions
Brand name: (Glucophage) Tablets per oral / Twice daily / 90 days duration
Brand name: (Pergoline) Tablets per oral / single dose per week / 90 days duration
DRUGMetformin Hydrochloride 500 MG + Cabergoline 0.5 MG
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
Sponsors
Al-Rasheed University College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index (BMI) | at Baseline, and after 90 days | Measured in Kg/m² as a part of hormone status changes analysis |
| Serum Anti-Müllerian hormone (AMH) | at Baseline, and after 90 days | Measured in ng/mL as a part of hormone status changes analysis |
| Serum Testosterone | at Baseline, and after 90 days | Measured in ng/mL as a part of hormone status changes analysis |
| Serum Luteinizing hormone (LH) | at Baseline, and after 90 days | Measured in mIU/mL as a part of hormone status changes analysis |
| Serum Follicular Stimulating Hormone (FSH) | at Baseline, and after 90 days | Measured in mIU/mL as a part of hormone status changes analysis |
| Serum Prolactin (PRL) | at Baseline, and after 90 days | Measured in ng/mL as a part of hormone status changes analysis |
| Mean number of dominant follicles (DF) | at Baseline, and after 90 days | Calculated by ultrasonography as a part of the ultrasonic analysis |
| Mean Resistive Index (RI) | at Baseline, and after 90 days | Calculated by ultrasonography as a part of the ultrasonic analysis |
| Serum Anti-GAD antibody | at Baseline, and after 90 days | Measured in ng/mL as a part of inflammatory markers analysis |
| Serum Anti-GnRH antibody | at Baseline, and after 90 days | Measured in pg/mL as a part of inflammatory markers analysis |
| Serum IL-18 Level | at Baseline, and after 90 days | Measured in pg/mL as a part of inflammatory markers analysis |
Countries
Iraq
Outcome results
None listed