NCT01463969

Brief Summary

In the present study, serum pentraxin 3 level and its relationship with insulin resistance were determined in patients with Polycystic Ovary Syndrome (PCOS. It was found that PTX3 level is increased in patients with PCOS and it is positively correlated with HOMA-IR.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2010

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 2, 2011

Completed
Last Updated

November 2, 2011

Status Verified

October 1, 2011

First QC Date

October 23, 2011

Last Update Submit

November 1, 2011

Conditions

PCOS

Keywords

PCOS and PTX3 levels

Outcome Measures

Primary Outcomes (1)

  • Level of of pentraxin3 in cases with Polycystic Ovarian Syndrome

    Mean PTX3 was significantly higher in patients with PCOS. This means that there is increased level of inflamation in patients with PCOS.

    1 year

Secondary Outcomes (1)

  • Relationship of PTX3 with insuline resistance in patients with PCOS.

    1 year

Study Arms (2)

PCOS patients

Control group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

40 PCOS patients and 40 healty controls

You may qualify if:

  • Absence of significant abnormalities on physical examination except hirsutism
  • No lipid lowering, hypoglycemic, antihypertensive or hormone replacement therapy
  • Normal thyroid function and prolactin level
  • Absence of history or evidence of metabolic, cardiovascular, respiratory or hepatic disease

You may not qualify if:

  • Pregnant
  • Possible ovarian tumors,
  • Congenital adrenal hyperplasia or
  • BMI greater than 35 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Gulhane School of Medicine Dep. of Endocrine and Metabolism

Ankara, 06018, Turkey (Türkiye)

Location

Gulhane School of Medicine Dep. of Endocrinology and Metabolism

Ankara, 06018, Turkey (Türkiye)

Location

Gulhane School of Medicine

Ankara, 06018, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Aydogan Aydogdu, MD

    Gulhane School of Medicine Dep. of Endocrinology and Metabolism

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 23, 2011

First Posted

November 2, 2011

Study Start

May 1, 2010

Study Completion

May 1, 2011

Last Updated

November 2, 2011

Record last verified: 2011-10

Locations

TU(3)