Correlation of Insulin Resistance With Hormonal and Ovarian Morphological Characteristics in Patients With Polycystic Ovarian Syndrome

We designed a study to determine if ovarian volume (OV) and/or follicle number (FN) are independently associated with abnormal metabolic findings in women diagnosed with PCOS. We hypothesized that ovarian morphology but not follicle number would be associated with a significantly higher odds of hyperinsulinemia among women with PCOS.

Study Overview

• Status: Not yet recruiting
• Conditions: Study the Relationship Between Insulin Resistance With Hormonal and Ovarian Morphological Characteristics in Patients With Polycystic Ovarian Syndrome
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Fatma Elhawary, MRCOG; Phone Number: 01144597490; Email: fatma.fathy@ngu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 41 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women with PCOS attending the outpatient clinic in Kasr Alainy Hospital in the reproductive age group (20:40 years)

Description

Inclusion Criteria:

A-patients met the Rotterdam criteria of PCO with two out of three of the following:

1. oligo-or-anovulation
2. clinical and/or biochemical hyperandrogenism
3. the presence of 10 or more antral follicles in one ovary and/or a maximum ovarian volume > 10cc B-reproductive age group (16:45 years) C-BMI <40

Exclusion Criteria:

A-age >40 years B-BMI>40 C-previous ovarian surgery D-chronic medical disorders [DM , HTN , ...]

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correlation between the ovarian volume and Insulin resistance	January 2023- June 2023
Correlation between the antral follicular count and insulin resistance	January 2023- June 2023

Secondary Outcome Measures

Outcome Measure	Time Frame
Correlation between anti-mullerian hormone values and insulin resistance	January 2023- June 2023
Correlation between FSH values and insulin resistance	January 2023- June 2023
Correlation between LH values and insulin resistance	January 2023- June 2023
Correlation between body mass index and insulin resistance	January 2023- June 2023
Correlation between hirsutism and insulin resistance	January 2023- June 2023

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: December 14, 2022
• First Submitted That Met QC Criteria: December 14, 2022
• First Posted (Estimate): December 22, 2022

Study Record Updates

• Last Update Posted (Estimate): December 22, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Hyperinsulinism; Polycystic Ovary Syndrome; Syndrome; Insulin Resistance
• Other Study ID Numbers: 0000000 (Other Identifier: Rheumatology Research Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No