Women With Polycystic Ovary Syndrome Are at High Risk for Cardiac Insults

Cardiac Disease Clinical Trial

Official title:

Women With Polycystic Ovary Syndrome Are at High Risk to Cardiac Insults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05344547
• Other study ID #: 35179/1/22
• Status: Completed
• Start date: March 21, 2020
• Est. completion date: November 17, 2021

Study information

• Verified date: April 2022
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 17, 2021
• Est. primary completion date: August 15, 2021
• Gender: Female
• Age group: 30 Years to 40 Years

Eligibility

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.

Exclusion Criteria:

• Age younger than 30 years old, BMI>35 kg/m2, presence of acute or chronic inflammatory diseases, diabetes mellitus, hyperprolactinemia, thyroid dysfunction, Cushing's syndrome, congenital adrenal hyperplasia, adrenal tumor or ovarian tumor, autoimmune disease, malignancy, central nervous system disease, current or previous use of oral contraceptives within 6 months of enrollment were excluded from the study. Patients had congenital cardiac lesions, manifestations of atherosclerosis or family history of cardiac or cerebrovascular insults, ejection fraction <50%, regional wall motion abnormalities and significant valvular diseases were excluded.

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases
• Polycystic Ovary Syndrome

Intervention

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).

Locations

Country	Name	City	State
Egypt	Tanta university	Tanta	El-Gharbyia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

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