Description of Fertility and Pregnancies in Patients With Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 473
- 试验地点
- 1
- 主要终点
- Description of the mode of conception
研究概览
简要总结
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder among women of reproductive age and affects approximately 10% of women worldwide. The diagnosis is based on the Rotterdam criteria established in 2003 and updated in the latest recommendations from the European Society of Human Reproduction (ESHRE) in 2023. The diagnosis of PCOS is based on the presence of 2 of the following 3 criteria:
- Oligo-anovulation
- Clinical and/or biological hyperandrogenism
- Polycystic ovary morphology (PCOM) on imaging It is also the leading cause of anovulatory infertility, with a 15-fold increased risk of infertility.
It is therefore a major cause of anovulatory infertility, but its pathophysiological mechanisms remain complex and multifactorial, involving interactions between genetic, metabolic, hormonal, and environmental factors. Prior to embarking on a fertility treatment plan, it is essential to better understand how these various factors influence ovarian function and reproductive capacity in patients with PCOS. Identifying and characterizing factors associated with fertility-such as hormonal profiles, insulin sensitivity, and metabolic markers-could help better predict future fertility and optimize personalized care and fertility outcomes. The aim of this study is therefore to identify modifiable factors influencing the fertility of PCOS patients phenotyped at La Pitié-Salpêtrière hospital.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •PCOS group:
- •Aged between 18 and 45 years old
- •Female with a diagnosis of PCOS according to ESHRE criteria
- •Previouslu enrolled in METABOPK research
- •Inclusion Criteria- Control group
- •Aged between 18 and 45 years old
- •Female with normal metabolic and hormonal profiles
- •Previouslu enrolled in METABOPK research
排除标准
- •A prior diagnosis of type 1 or type 2 diabetes
- •A diagnosis of non-classical adrenal block
- •Use of hormonal therapy, oral antidiabetic medication, lipid-lowering medication, antihypertensive medication, corticosteroids, or spironolactone
- •Menopause or current pregnancy
- •Lack of data on BMI, insulin levels, and fasting blood glucose
- •Patients who do not speak French
- •Patients under legal guardianship, conservatorship, or curatorship
研究组 & 干预措施
PCOS patients
PCOS patients aged between 18 and 45 years
干预措施: Questionnaires (Other)
Control
Control (PCOS free)
干预措施: Questionnaires (Other)
结局指标
主要结局
Description of the mode of conception
时间窗: Through study completion, an average of 1 year
Description of the mode of conception: spontaneous or induced; if induced, by which ART technique or following which treatment to improve PCOS symptoms (inositol, GLP-1 analog, metformin, lifestyle and dietary changes, etc.). These informations will be colected from medical records and frome the specific questionnaire.
次要结局
- Description of the treatment protocols for infertility(Through study completion, an average of 1 year)
- Description of obstetric complications(Through study completion, an average of 1 year)
- Identification of hormonal and metabolic factors associated with infertility and obstetric complications(Through study completion, an average of 1 year)