NCT05929950

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
29 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

July 3, 2023

Status Verified

July 1, 2023

Enrollment Period

7 months

First QC Date

June 19, 2023

Last Update Submit

July 1, 2023

Conditions

Polycystic Ovary Syndrome

Keywords

autoimmunityobesityPolycystic ovary syndrome

Outcome Measures

Primary Outcomes (1)

  • measuring serum anti-ovarian, anti-nuclear, anti-double stranded and anti-thyroid antibodies

    Theses markers will be measured using ELISA technique

    3 months after recruitment

Study Arms (2)

patients with PCOS

control group

Eligibility Criteria

Age12 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsbecause the study is about polycystic ovary syndrome
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

women

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university

Sohag, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary SyndromeAutoimmune DiseasesObesity

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesImmune System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Ola AH Hamed, Assistant lecturer

CONTACT

2001061137434ola.hamed@med.sohag.edu.eg

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

June 19, 2023

First Posted

July 3, 2023

Study Start

August 1, 2023

Primary Completion

March 1, 2024

Study Completion

June 1, 2024

Last Updated

July 3, 2023

Record last verified: 2023-07

Locations

EG(1)