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临床试验/NCT05734287
NCT05734287招募中不适用

Polycystic Ovaries in Young Girls Presenting With Hyperandrogenism

Woman's Health University Hospital, Egypt1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2024年6月28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
260
试验地点
1
主要终点
The frequency of polycystic ovary syndrome among young reproductive females presenting with hyperandrogenism: a mixed cohort study

研究概览

简要总结

This mixed cohort study will test the frequency of PCOS among young females presenting with one of the clinical hyperandrogenism criteria: acne, hirsutism and/or hair loss. Diagnosis will be based on the recent PCOS clinical, biochemical and biophysical criteria recently published " International evidence-based guideline for the assessment and management of polycystic ovary syndrome (PCOS) 2018".

详细描述

Irregular menstrual cycles are defined as:

  • normal in the first year post menarche as part of the pubertal transition
  • > 1 to < 3 years post menarche: < 21 or > 45 days
  • > 3 years post menarche to perimenopause: < 21 or > 35 days or < 8 cycles per year
  • > 1 year post menarche > 90 days for any one cycle
  • Primary amenorrhea by age 15 or > 3 years post thelarche (breast development) When irregular menstrual cycles are present a diagnosis of PCOS should be considered.

Biochemical hyperandrogenism: Calculated free testosterone, free androgen index or calculated bioavailable testosterone. Androstenedione and dehydroepiandrosterone sulfate (DHEAS) could be considered if total or free testosterone are not elevated. (ELIZA or radioimmunoassay).

A comprehensive history and physical examination should be completed for symptoms and signs of clinical hyperandrogenism, including acne, alopecia and hirsutism and, in adolescents, severe acne and hirsutism using the modified Ferriman Gallwey score (mFG). Transvaginal (transabdominal if virgins) Ultrasound and polycystic ovarian morphology: Ultrasound should not be used for the diagnosis of PCOS in those with a gynaecological age of < 8 years (< 8 years after menarche), due to the high incidence of multi-follicular ovaries in this life stage. Transabdominal ultrasound reporting is best focused on ovarian volume with a threshold of ≥ 10ml. Endovaginal U/S should show a follicle number per ovary of ≥ 20 and/or an ovarian volume ≥ 10ml, ensuring no corpora lutea, cysts or dominant follicles are present.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
15 Years 至 35 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Clinical hyperandrogenism

排除标准

  • Age less than 15 or more than 35 years.

结局指标

主要结局

The frequency of polycystic ovary syndrome among young reproductive females presenting with hyperandrogenism: a mixed cohort study

时间窗: 7 months

次要结局

未报告次要终点

研究者

发起方
Woman's Health University Hospital, Egypt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Atef Darwish

Professor of Obstetrics and Gynecology

Woman's Health University Hospital, Egypt

研究点 (1)

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