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

NCT05661565 | Unknown

• 1 other identifier: 0000000
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Study the Relationship Between Insulin Resistance With Hormonal and Ovarian Morphological Characteristics in Patients With Polycystic Ovarian Syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

Interventions

No intervention OTHER

We try to find an association between insulin resistance with ovarian hormonal and morphological characteristics in patients with polycystic ovarian syndrome

Eligibility Criteria

• Age: 16 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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)

You may qualify if:

• A-patients met the Rotterdam criteria of PCO with two out of three of the following:
• oligo-or-anovulation
• clinical and/or biochemical hyperandrogenism
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Central Study Contacts

Fatma Elhawary, MRCOG

CONTACT

01144597490; fatma.fathy@ngu.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: December 22, 2022
• Study Start: January 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: July 31, 2023
• Last Updated: December 22, 2022

Record last verified: 2022-12