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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05344547

Enrollment

150

Registered

2022-04-25

Start date

2020-03-21

Completion date

2021-11-17

Last updated

2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Disease

Brief 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

Interventions

DIAGNOSTIC_TESTCardiac 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).

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 40 Years

Inclusion criteria

Infertile PCOS women older than 30 years and free of

Exclusion criteria

were enrolled in the study as PCOS group. Fifty non-PCOS women of age- and BMI cross-matched to the enrolled PCOS women with regular menstrual cycles or fertile if married were collected as control (Non-PCOS) group. Only women who signed the written informed consent will be enrolled in the study.

Design outcomes

Primary

Measure	Time frame	Description
Abnormal Cardiac Outcomes	1 to 3 months	incidence of abnormal cardiac risk parameters among PCOS women who were apparently cardiac free women

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026