The Role of Autoimmunity and Obesity in Polycystic Ovary... | NCT05929950

Studies
The Role of Autoimmunity and Obesity in Polycystic Ovary Syndrome

NCT05929950

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Jul 3, 2023Actual

Enrollment

90Estimated

Phase

Not provided

Conditions

Polycystic Ovary Syndrome

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2023Estimated

Primary Completion Date

Mar 1, 2024Estimated

Completion Date

Jun 1, 2024Estimated

First Submitted Date

Jun 19, 2023

First Submission Date that Met QC Criteria

Jul 1, 2023

First Posted Date

Jul 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2023

Last Update Posted Date

Jul 3, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

because the study is about polycystic ovary syndrome

Minimum Age

12 Years

Maximum Age

55 Years

Standard Ages

ChildAdult

Study Population

women

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ola AH Hamed, Assistant lecturer	Contact	2001061137434		ola.hamed@med.sohag.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag university		Sohag			Egypt	Ola AH Hamed, assistant lecturer

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Dec 14, 2025
Reset	Jan 5, 2026

Submission Tracking

Estimated Results First Submitted Date

Dec 14, 2025

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Dec 14, 2025			Jan 5, 2026

Condition Browse Module

MeSH Terms

ID	Term
D011085	Polycystic Ovary Syndrome
D001327	Autoimmune Diseases
D009765	Obesity

Ancestor Terms

ID	Term
D010048	Ovarian Cysts
D003560	Cysts
D009369	Neoplasms
D010049	Ovarian Diseases
D000291

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
patients with PCOS
control group