Evaluation of Endocrine and Metabolic Parameters in the New Diagnostic Phenotypes of Polycystic Ovary Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Universidad Nacional de Córdoba.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Fundación Florencio Fiorini
Information provided by:
Universidad Nacional de Córdoba
ClinicalTrials.gov Identifier:
NCT00784615
First received: November 3, 2008
Last updated: November 18, 2008
Last verified: October 2008
  Purpose

Polycystic ovary syndrome (PCOS) is a very frequent endocrine disease of women in reproductive age, with an estimated prevalence of 5 to 10 % according to the studied population. In 2003 a committee of experts joined in Rotterdam under the auspice of the American Society for Reproductive Medicine and the European Society for Human Reproduction and Embryology, defined diagnostic criteria. It should include unless two of the following: menstrual irregularities; excess of male hormones (clinic or biochemical) and polycystic ovaries under ultrasound examination; giving rise to four subgroups or phenotypes:

1- Women with polycystic ovaries, hyperandrogenism and oligoamenorrhea . 2. Women with normal ovaries, hyperandrogenism and oligoamenorrhea. 3- Women with polycystic ovaries, oligoamenorrhea without hyperandrogenism. 4- Women with polycystic ovaries, hyperandrogenism with normal menses. PCOS shares components of Metabolic Syndrome for the high prevalence of insulin resistance (abdominal obesity, impaired glucose tolerance, type 2 diabetes, hypertension, endothelial dysfunction, impaired lipid profile and probably cardiovascular disease). All these findings lead us to assume that women with PCOS could have an increased risk of developing cardiovascular disease. Nevertheless it is premature to assume that every PCOS phenotype has the same cardiac and metabolic risk factors. So, it is important to evaluate the endocrine and metabolic characteristic in different phenotypes of PCOS to prevent the co morbidities that predispose to cardiovascular disease. And of course to avoid unnecessary measures in groups that could not show increased risk.


Condition Intervention
Polycystic Ovary Syndrome
Procedure: Blood samples, transvaginal ultrasound

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Descriptive, Transversal Study of Evaluation of Cardiovascular Risks Factors and Prevalence of Metabolic Syndrome in the Different Phenotypes of Women With Polycystic Ovary Syndrome

Resource links provided by NLM:


Further study details as provided by Universidad Nacional de Córdoba:

Primary Outcome Measures:
  • Serum levels: Total, bioavailable testosterone, Free androgen index. Total, LDL and HDL Cholesterol, Triglycerides, insulinemia, OGTT, HOMA index, Adiponectin, C Reactive Protein. Transvaginal Ultrasound:Number,size of ovary follicles and ovary volume [ Time Frame: At the begining of the study ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood samples


Estimated Enrollment: 80
Study Start Date: December 2007
Groups/Cohorts Assigned Interventions
1
Women with polycystic ovaries, oligo or anovulation and hyperandrogenism.
Procedure: Blood samples, transvaginal ultrasound
Total testosterone, bioavailable testosterone, Free androgen index, Total cholesterol, LDL Cholesterol, HDL Cholesterol, Triglycerides, insulinemia, OGTT, HOMA index, Adiponectin, C Reactive Protein
2
Women with polycystic ovaries and oligo or anovulation without hyperandrogenism
Procedure: Blood samples, transvaginal ultrasound
Total testosterone, bioavailable testosterone, Free androgen index, Total cholesterol, LDL Cholesterol, HDL Cholesterol, Triglycerides, insulinemia, OGTT, HOMA index, Adiponectin, C Reactive Protein
3
Women with normal ovaries, oligo or anovulation and hyperandrogenism
Procedure: Blood samples, transvaginal ultrasound
Total testosterone, bioavailable testosterone, Free androgen index, Total cholesterol, LDL Cholesterol, HDL Cholesterol, Triglycerides, insulinemia, OGTT, HOMA index, Adiponectin, C Reactive Protein
4
Women with normal ovaries, oligo or anovulation and hyperandrogenism
Procedure: Blood samples, transvaginal ultrasound
Total testosterone, bioavailable testosterone, Free androgen index, Total cholesterol, LDL Cholesterol, HDL Cholesterol, Triglycerides, insulinemia, OGTT, HOMA index, Adiponectin, C Reactive Protein
5
Women with out polycystic ovary syndrome
Procedure: Blood samples, transvaginal ultrasound
Total testosterone, bioavailable testosterone, Free androgen index, Total cholesterol, LDL Cholesterol, HDL Cholesterol, Triglycerides, insulinemia, OGTT, HOMA index, Adiponectin, C Reactive Protein

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women in reproductive age with diagnosis of polycystic ovary syndrome according to Rotterdam criteria

Criteria

Inclusion Criteria:

Two of the following

  • Ovulatory Dysfunction: Clinically defined by oligomenorrhea (menstrual cycles lasting more than 35 days) or amenorrhea (lacking of menstruations in the last 90 days). In patients with menstrual cycles between 25 and 35 days, a serum level of progesterone drawn during days 21 to 23 of cycle < a 4 ng/ml.
  • Clinical hyperandrogenism defined for the presence of hirsutism, acne, androgenic alopecia) and or biochemical (increases in total testosterone, bioavailable testosterone or free androgen index).
  • Polycystic Ovaries: Defined by the presence, in as less one ovary, of 12 or more follicles (measuring 2 to 9 mm in diameter) and or increased ovarian volume > 10 mL).

Exclusion Criteria:

  • Hyperprolactinemia
  • Hypothyroidism
  • Other causes of hyperandrogenism like Cushing's Syndrome, congenital adrenal hyperplasia, androgens secreting tumors
  • Drug therapy used three months previous to enrollment in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00784615

Locations
Argentina
Hospital Universitario de Maternidad y Neonatología Recruiting
Cordoba, Argentina, X5000
Contact: Paula S Mereshian, MD    54 351 433 1053    paula.mereshian@gmail.com   
Principal Investigator: Carolina Fux Otta, MD         
Sponsors and Collaborators
Universidad Nacional de Córdoba
Fundación Florencio Fiorini
Investigators
Principal Investigator: Carolina Fux Otta, MD Hospital Universitario de Maternidad y Neonatología. Universidad Nacional de Córdoba
Study Director: Marta Fiol de Cuneo, MD Catedra de Fisiología Humana. Universidad Nacional de Córdoba
  More Information

Additional Information:
Publications:

Responsible Party: Carolina Fux Otta, Hospital Universitario de Maternidad y Neonatología. UNC
ClinicalTrials.gov Identifier: NCT00784615     History of Changes
Other Study ID Numbers: Fux-2
Study First Received: November 3, 2008
Last Updated: November 18, 2008
Health Authority: Argentina: Human Research Bioethics Committee

Keywords provided by Universidad Nacional de Córdoba:
Phenotypes of Polycystic Ovary Syndrome
Cardiovascular risk factors
Adiponectin
C Reactive Protein

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 30, 2014