Trials / Completed
CompletedNCT05344547
Women With Polycystic Ovary Syndrome Are at High Risk for Cardiac Insults
Women With Polycystic Ovary Syndrome Are at High Risk to Cardiac Insults
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 150 (actual)
- Sponsor
- Tanta University · Academic / Other
- Sex
- Female
- Age
- 30 Years – 40 Years
- Healthy volunteers
- —
Summary
Objectives: Evaluation of the cardiovascular (CV) risk in a sample of CV asymptomatic infertile women with polycystic ovary syndrome (PCOS). Patients \& Methods: 100 infertile PCOS women older than 30 years (PCOS group) and 50 fertile non-PCOS women (Non-PCOS group) underwent gynecological and laboratory diagnosis and then underwent a diagnostic protocol consisting of determination of body mass index (BMI), Homeostasis model assessment of insulin resistance (HOMA-IR) scoring and cardiologic evaluation using echocardiography, estimation of carotid artery intima-media thickness (CIMT), coronary artery calcium (CAC) score using multi-slice non-contrast cardiac CT and cardiac risk ratio (CRR). Study outcomes included the incidence of abnormal cardiac risk parameters and the determination of the best minimally invasive modality to be used as a screening test for these women.
Detailed description
Women attending the infertility clinics at Tanta and Benha University Hospitals were eligible for evaluation for PCOS as a cause of infertility. Gynecological evaluation entails data concerning present and past history of menstrual regularity, previous pregnancy for married women, previous investigations or therapies for PCOS or infertility. PCOS was diagnosed depending on the presence of at least two of the Rotterdam criteria
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Cardiac risk ratio (CRR) | Cardiac risk ratio (CRR) was calculated according to Genest et al. (23) as serum total cholesterol (TC) level divided by serum high-density lipoprotein-cholesterol (HDL-c) level and woman with CRR at ≥3.5 was considered at risk of cardiac disease (24). |
Timeline
- Start date
- 2020-03-21
- Primary completion
- 2021-08-15
- Completion
- 2021-11-17
- First posted
- 2022-04-25
- Last updated
- 2022-04-25
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT05344547. Inclusion in this directory is not an endorsement.