The Role of Autoimmunity and Obesity in Polycystic Ovary Syndrome

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05929950
Collaborator
(none)
90
1
10
9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    90 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    The Role of Autoimmunity and Obesity in Polycystic Ovary Syndrome
    Anticipated Study Start Date :
    Aug 1, 2023
    Anticipated Primary Completion Date :
    Mar 1, 2024
    Anticipated Study Completion Date :
    Jun 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    patients with PCOS

    control group

    Outcome Measures

    Primary Outcome Measures

    1. measuring serum anti-ovarian, anti-nuclear, anti-double stranded and anti-thyroid antibodies [3 months after recruitment]

      Theses markers will be measured using ELISA technique

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 55 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sohag university Sohag Egypt

    Sponsors and Collaborators

    • Sohag University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ola Ahmed Hamed, Assistant lecturer, Sohag University
    ClinicalTrials.gov Identifier:
    NCT05929950
    Other Study ID Numbers:
    • soh-med-23-06-04MD
    First Posted:
    Jul 3, 2023
    Last Update Posted:
    Jul 3, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ola Ahmed Hamed, Assistant lecturer, Sohag University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 3, 2023