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

NCT00784615 | Unknown

• 1 other identifier: Fux-2
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polycystic Ovary Syndrome

Keywords

Phenotypes of Polycystic Ovary Syndrome; Cardiovascular risk factors; Adiponectin; C Reactive Protein

Outcome Measures

Primary Outcomes (1)

• 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

  At the begining of the study

Study Arms (5)

1

Women with polycystic ovaries, oligo or anovulation and hyperandrogenism.

Procedure: Blood samples, transvaginal ultrasound

2

Women with polycystic ovaries and oligo or anovulation without hyperandrogenism

Procedure: Blood samples, transvaginal ultrasound

3

Women with normal ovaries, oligo or anovulation and hyperandrogenism

Procedure: Blood samples, transvaginal ultrasound

4

Women with normal ovaries, oligo or anovulation and hyperandrogenism

Procedure: Blood samples, transvaginal ultrasound

5

Women with out polycystic ovary syndrome

Procedure: Blood samples, transvaginal ultrasound

Interventions

Blood samples, transvaginal ultrasound PROCEDURE

Total testosterone, bioavailable testosterone, Free androgen index, Total cholesterol, LDL Cholesterol, HDL Cholesterol, Triglycerides, insulinemia, OGTT, HOMA index, Adiponectin, C Reactive Protein

1; 2; 3; 4; 5

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Nacional de Córdoba: lead
• Fundación Florencio Fiorini: collaborator

Study Sites (1)

Hospital Universitario de Maternidad y Neonatología

Córdoba, Córdoba Province, X5000, Argentina

RECRUITING

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Related Links

• Funding non profit organization

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Carolina Fux Otta, MD

  Hospital Universitario de Maternidad y Neonatología. Universidad Nacional de Córdoba

  PRINCIPAL INVESTIGATOR

• Marta Fiol de Cuneo, MD

  Catedra de Fisiología Humana. Universidad Nacional de Córdoba

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 3, 2008
• First Posted: November 4, 2008
• Study Start: December 1, 2007
• Last Updated: November 19, 2008

Record last verified: 2008-10

Locations

AR (1)