The Role of Autoimmunity and Obesity in Polycystic Ovary Syndrome

July 1, 2023 updated by: Ola Ahmed Hamed, Sohag University
The goal of the study is to detect autoantibodies in the serum of the women with PCOS and evaluate the obesity markers to investigate the the role of autoimmunity and obesity in PCOS

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

women

Description

Inclusion Criteria:

  • patients diagnosed with PCOS according to the Rotterdam (2003) criteria.

Exclusion Criteria:

  • Patients with other causes of hyperandrogenism as congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome, hyperprolactinemia, virilizing ovarian or adrenal tumors and those taking drugs affecting insulin resistance, such as estrogens, oral contraceptives and corticosteroids during the previous three months before the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
control group
patients with PCOS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measuring serum anti-ovarian, anti-nuclear, anti-double stranded and anti-thyroid antibodies
Time Frame: 3 months after recruitment
Theses markers will be measured using ELISA technique
3 months after recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

June 19, 2023

First Submitted That Met QC Criteria

July 1, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

July 1, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • soh-med-23-06-04MD

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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