Prevalence of Polycystic Ovary Syndrome In Trinidad
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Prevalence of PCOS and its symptoms
研究概览
简要总结
According to World Health Organization (WHO), in 2010, Polycystic Ovarian Syndrome (PCOS) affected approximately 116 million women worldwide (3.4% of the population). It has been considered one of the most common causes of female infertility and the most common endocrine disorder. The standard diagnosis for the syndrome dates back to international conferences organized by the National Institutes of Health (NIH) in 1990 and the Rotterdam European Society of Human Reproduction and Embryology/ American Society for Reproductive Medicine (ESHRE/ASRM) sponsored PCOS consensus workshop group in 2003 and 2004. Clinical manifestations of the disease may include menstrual irregularities, amenorrhea, ovulation-related infertility, polycystic ovaries, and signs of androgen excess such as acne and hirsutism. This condition may also lead to chronic diseases such as obesity, type 2 diabetes (T2D), dyslipidaemia, and cardiovascular events. Despite the increasing knowledge concerning PCOS, the global picture of the disorder is deficient in a number of geographic regions. Understanding the global prevalence will help to better assess the public health and economic implications of PCOS in Trinidad, allow for improved screening methods, help elucidate the underlying factors and foster improved understanding of the molecular mechanisms in improving the evolutionary process.
详细描述
Background According to World Health Organization (WHO), in 2010, Polycystic Ovarian Syndrome (PCOS) affected approximately 116 million women worldwide (3.4% of the population). This condition caused symptoms in about 5-10% of women of reproductive age (12 - 45 years). It has been considered one of the most common causes of female infertility and the most common endocrine disorder. The standard diagnosis for the syndrome dates back to international conferences organized by the National Institutes of Health (NIH) in 1990 and the Rotterdam European Society of Human Reproduction and Embryology/ American Society for Reproductive Medicine (ESHRE/ASRM) sponsored PCOS consensus workshop group in 2003 and 2004 (Rotterdam ESHER/ASRM-sponsored PCOS consensus workshop group 2004). Clinical manifestations of the disease may include menstrual irregularities, amenorrhea, ovulation-related infertility, polycystic ovaries, and signs of androgen excess such as acne and hirsutism. This condition may also lead to chronic diseases such as obesity, type 2 diabetes (T2D), dyslipidemia, and cardiovascular events.
Statement of Problem
Despite the increasing knowledge concerning PCOS, the global picture of the disorder is deficient in a number of geographic regions. Understanding the global prevalence and phenotypic presentation of any common disorder, including PCOS, allows for:
- A determination of the prevalence and associated morbidities of the disorder, to better assess the public health and economic implications of PCOS in this region.
- A determination of the phenotype of PCOS in this region, allowing for improved screening methods.
- The elucidation of underlying environmental or ethnic factors that may affect the prevalence, severity or complications of the disorder, via comparison of data between countries.
- The elucidation of genetic variants underlying the disorder in this region, fostering and improved understanding of the molecular mechanisms underlying the disorder and a better understanding of the evolutionary selection processes that have paradoxically resulted in the current high prevalence of the disorder in the face of obvious reproductive deficits.
Benefit These data would not only lead to an improved understanding of the public health implications of the disorder in Trinidad but also potentially highlight novel etiologic avenues and therapeutic targets.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, ages 18 to 45 years., all ethnic backgrounds.
- •The participants must have at least one of the following two features:
- •i) Dermatological signs or complains of clinical hyperandrogenism such as unwanted facial or body hair, loss of scalp hair (alopecia) or persistence acne (pimple).
- •ii) Signs or complains of ovulatory dysfunction such as irregular menses (oligomenorrhoea, amenorrhea or polymenorrhoea), history of anovulation or ultrasonographic findings of polycystic ovarian morphology.
排除标准
- •Women less than 18 years or older than 45 years
- •Women who are pregnant at the time of evaluation
- •Postmenopausal women
- •Women who had undergone hysterectomy and/or bilateral oophorectomy
- •Anything that would place the individual at increased risk or preclude the individuals compliance with or completion of the study.
- •Unwillingness to participate or difficulty understanding the consent process or the study objectives and requirements.
结局指标
主要结局
Prevalence of PCOS and its symptoms
时间窗: 1 year
To determine the prevalence of PCOS in Trinidad, data collection will include blood collection to assess hormones, thyroids, AMH, IR and other parameters as listed in the procedure. Additionally, participants will be issued a questionnaire (see attached) to assess their demographics, history of medical conditions, sexual activity, medications, contraceptive methods, Menes history, weight, height, waist to hip ratio, physical check for hirsutism and acanthosis will be checked for using various approved scales as provided in the questionnaire. The hyperandrogenic features will be evaluated using the modified Ferriman-Gallwey Hirstism Score. Mental health will be assessed using BECKS inventory. Physical activity would be assessed using SF-12 scale. Menstrual irregularities will be assessed using the Ruta Menorrghia Scale
次要结局
未报告次要终点
研究者
Stephanie Mohammed
Principal Investigator
The University of The West Indies