Evaluation of Endocrine and Metabolic Parameters in the New Diagnostic Phenotypes of Polycystic Ovary Syndrome
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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 |
- 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 |
Women in reproductive age with diagnosis of polycystic ovary syndrome according to Rotterdam 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| 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 | |
| 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:
|
Polycystic Ovary Syndrome Ovarian Cysts Cysts Neoplasms Ovarian Diseases |
Adnexal Diseases Genital Diseases, Female Gonadal Disorders Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013