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临床试验/NCT05926115
NCT05926115招募中不适用

Phenotype and Epidemiology of the Polycystic Ovary Syndrome (PCOS) in Colombia (PEP - Colombia) Study.

Instituto de fertilidad humana, InSer1 个研究点 分布在 1 个国家目标入组 626 人开始时间: 2023年3月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
626
试验地点
1
主要终点
Prevalence of PCOS

研究概览

简要总结

The goal of this observational study is to know the prevalence of PCOS among economically productive and reproductive age women from Medellín and the Valle de Aburrá, Colombia. The main questions it aims to answer are:

  1. What is the phenotypic distribution of PCOS detected in women seeking medical attention as a requirement for employment in Medellín and the Valle de Aburrá, Colombia?
  2. What is the effect of environmental factors, such as geographical location and diet, and biological factors (such as obesity and ethnicity/race) on the prevalence and phenotype of PCOS in this populatión?

Participants will undergo anthropometric measurements and physical examination for hirsutism, acne, alopecia, acanthosis nigricans, and thyroid enlargement. During the initial visit, a transvaginal or transabdominal pelvic ultrasonography will be performed. A sample of venous blood will be collected in plain tubes for serum cryopreservation and for immediate glucose estimation. Some participants will be rescheduled for a second evaluation visit for additional assessment when they have a possible PCOs.

详细描述

During the first visit, potential study participants, scheduled for routine occupational pre-admission medical examination at Colmédicos Medical Centre, will be invited to participate in the study. Eligible study participants will be counselled on the objectives of the study and the study protocol and a copy of the consent form will be handed to them. A confidential study register containing details of potential study participants (name, age, height, weight, and contact) will be start on the first visit day. Informed written consent will be obtained from each study participant before recruitment for the study in the evaluation visit number one. All study participants personal data will be protected according to the law (ley 1581de Colombia).

  1. Evaluation Visit #1:

After obtaining an informed consent, data will be collected from each study participant using a standard format in a clinical report form (CRF) for uniform data collection from all participants. Each CRF will bear a unique serial identification number and will be written in the local language. The CRF will be filled by a trained researcher (including the PI, co-investigators and medically trained research assistants). All CRF will be checked for missing data within 24 hours of completion, and any missing data will be detected and collected immediately. At no time, will the study personnel have access to the participant´s medical occupational records, following the restrictions defined in the colombian legislation (resolution 2346 de 2007, R 1918 de 2011).

Each participant will undergo anthropometric measurements (weight, height, waist circumference and hip circumference) and physical examination for hirsutism, acne, alopecia, acanthosis nigricans, and thyroid enlargement. Participants with an initial hirsutism (mFG) score of 4 or more (≥ 4) will be re-assessed by a physician. During the initial visit at Colmédicos, a transvaginal or transabdominal pelvic ultrasonography will be performed in all participants, based on the sexual history and consent form by trained gynecologists who are part of study investigators. A transvaginal ultrasound is the accepted and validated method to assess the ovarian morphology in the study of patients with PCOS.

After an overnight fast of at least 6 hours (ideally), a 18 ml sample of venous blood will be collected from each study participant (i.e., the basal fasting sample). About 12 ml of the venous blood will be collected in plain tubes for serum cryopreservation and subsequent analysis, and the remainder in plain tubes for immediate glucose estimation in serum. 2. Sample Processing:

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 18 to 45 years.
  • Participants with thyroid dysfunction on medication will be included only if their TSH level is normal (prior to or at re-evaluation)
  • Participants with hyperprolactinemia will be included only if their prolactin (PRL) level is normal (prior to or at re-evaluation) b) Exclusion criteria
  • a. Women who are pregnant at the time of evaluation b. Postmenopausal women

排除标准

  • Women who are pregnant at the time of evaluation
  • Postmenopausal women

结局指标

主要结局

Prevalence of PCOS

时间窗: Six months

Prevalence of PCOS among a medically unselected population-based sample representing the Latino population. In addition, Percentage of participants with phenotype A, B, C or D, among participants diagnosed with PCOS.

次要结局

  • Percentage of participants with obesity, endocrine disorders, metabolic syndrome, hyperandrogenism, hirsutism, oligomenorrhea, anovulation and irregular menses(Six months)

研究者

发起方
Instituto de fertilidad humana, InSer
申办方类型
Other
责任方
Sponsor

研究点 (1)

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