Impact of Glucose Metabolism Abnormalities on Live Birth Rate in South-East Asian Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,208
- 试验地点
- 1
- 主要终点
- Live birth rate at 24 months following enrollment into the study
研究概览
简要总结
Polycystic ovary syndrome (PCOS) is a common endocrine and reproductive disorder in which insulin resistance (IR) is proposed as a key pathophysiological feature of the disease's symptoms and consequences. Diabetes and rediabetes, a significant consequence of IR, are related to a higher risk of diabetes mellitus, future cardiovascular events, and adverse pregnancy outcomes.
详细描述
All Vietnamese infertile women with PCOS, according to the Rotterdam criteria present at IVFMD, will be enrolled in the study. Phenotypes of PCOS are classified into A, B, C, and D due to hyperandrogenism (HA), ovulatory dysfunction (OD), and polycystic ovarian morphology (PCOM)
- A: HA + OD + PCOM
- B: HA + OD
- C: HA + PCOM
- D: OD + PCOM
All patients enrolled in this study will have:
- Standard anthropometric data will be done by professional and experienced physicians according to standard study protocol: Weight, height, waist and hip circumference, waist-to-hip ratio, and BMI calculated, followed by World Health Organization guidelines for Asian women. Trained midwives evaluated hirsutism and acanthosis nigricans, and fat mass was measured in the abdomen area using specific calipers (Accu-Measure®).
- Gynecologic ultrasound scan
- Blood tests:
A fasting blood sample was obtained. Luteinizing hormone (LH) (with a coefficient of variation [CV] 2.3%), follicle-stimulating hormone (FSH) (CV 3.5%), estradiol (CV 2.7%), progesterone (CV: 6.2%), prolactin (CV: 5.2%), sex hormone binding globulin (SHBG) (CV 5.6%), total testosterone (CV 8.4%) were measured by Elesys technique, Cobas e411 system. FAI was calculated using the formula: FAI = serum testosterone in nmol/L/serum SHBG in nmol/L × 100. Thyroid stimulating hormone (TSH) (CV 6.0%), free thyroxin (fT4) (CV 5.05%) were measured by Access 2 immunoassay system. High-density lipoprotein cholesterol (HDL-C) (CV 2.4%), low-density lipoprotein cholesterol (LDL-C) (CV 2.0%), and triglyceride (CV 1.76%) were measured by Beckman Coulter AU480 system. Fasting serum insulin (CV 2.8%) was measured by Elesys technique, Cobas e411 system. The Homeostasis Model Assessment of Insulin Resistance Index (HOMA-IR) was used to estimate insulin sensitivity. HOMA-IR was calculated as FPG in mmol/L × fasting insulin in mIU/mL/22.5 (Matthews et al., 1985). A 2 mL blood sample was withdrawn and stored in a vacutainer with nature oxalate and EDTA additive.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Vietnamese women aged 18-40 years
- •Diagnosed with polycystic ovary syndrome (PCOS) according to the Rotterdam criteria (2003)
- •Having indications for infertility treatment
排除标准
- •Thyroid-stimulating hormone (TSH) > 5 mIU/mL
- •Serum prolactin (PRL) > 30 ng/mL
- •History of hypothyroidism
- •Cushing's syndrome
- •Premature ovarian insufficiency
- •Late-onset or non-classic congenital adrenal hyperplasia
- •Any other concomitant endocrinopathy
结局指标
主要结局
Live birth rate at 24 months following enrollment into the study
时间窗: From enrollment until delivery (up to 24 months after enrollment)
Live birth was defined as the delivery of a live infant after 22 weeks of gestation, regardless of the method of conception.
次要结局
- Gestational diabetes mellitus(From enrollment until delivery (up to 24 months after enrollment).)
- Preterm birth(From enrollment until delivery (up to 24 months after enrollment).)
- Gestational age at birth(At delivery (up to 24 months after enrollment).)
- Neonatal Intensive Care Unit (NICU) admission(At delivery (up to 24 months after enrollment).)
- Neonatal respiratory distress(At delivery (up to 24 months after enrollment).)
- Hypertensive disorders of pregnancy(From enrollment until delivery (up to 24 months after enrollment).)
- Miscarriage(From enrollment until delivery (up to 24 months after enrollment).)
- Birthweight(At delivery (up to 24 months after enrollment).)
- Baseline glycemic status (diabetes, prediabetes, or normal glucose tolerance before infertility treatment)(At baseline (at enrollment, before treatment).)