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

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ClinicalTrials.gov Identifier: NCT00784615
Recruitment Status : Unknown
Verified October 2008 by Universidad Nacional de Córdoba.
Recruitment status was:  Recruiting
First Posted : November 4, 2008
Last Update Posted : November 19, 2008
Sponsor:
Collaborator:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment
Polycystic Ovary Syndrome Procedure: Blood samples, transvaginal ultrasound

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Study Design

Study Type : Observational
Estimated Enrollment : 80 participants
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
Study Start Date : December 2007

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U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  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 [ Time Frame: At the begining of the study ]

Biospecimen Retention:   Samples Without DNA
Blood samples

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: November 4, 2008    Key Record Dates
Last Update Posted: November 19, 2008
Last Verified: October 2008

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