Comparison of Live Birth Rates Between Calorie-restricted Diets and Metformin Interventions Prior to Ovulation Induction Therapy in Patients With Overweight/Obese Polycystic Ovary Syndrome Combined With Infertility
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 406
- 试验地点
- 1
- 主要终点
- Live birth during the period of ovulation induction
研究概览
简要总结
Polycystic ovary syndrome (PCOS) is a common gynecological endocrine disease and a major cause of anovulatory infertility in reproductive-aged women. From 2010 to 2020, it was found that the prevalence of PCOS in reproductive-aged women in China reached 7.8%, an increase of 65% over 10 years ago. Many of them are overweight or obese. Weight loss including diet modifications can significantly reduce reproductive and metabolic disorders of PCOS and is recommended as a first step in the treatment of overweight or obese women with PCOS. Many weight loss programs have been proposed, including calorie-restriction diet (CRD) intervention. Whether CRD intervention prior to ovulation induction therapy could improve live birth rates in overweight/obese PCOS women has not been illustrated.
详细描述
Polycystic ovary syndrome (PCOS) is a common gynecological endocrine disease and a major cause of anovulatory infertility in reproductive-aged women. Rotterdam criteria state the definition of PCOS is that women must present with two of the following three signs/symptoms-hyperandrogenism, chronic anovulation/oligomenorrhea, and polycystic ovaries-in the absence of other diseases that promote these symptoms. From 2010 to 2020, it was found that the prevalence of PCOS in reproductive-aged women in China reached 7.8%, an increase of 65% over 10 years ago. Many of them are overweight or obese. Weight loss including diet modifications can significantly reduce reproductive and metabolic disorders of PCOS and is recommended as a first step in the treatment of overweight or obese women with PCOS. Many weight loss programs have been proposed, including calorie-restriction diet (CRD) intervention. Whether CRD intervention prior to ovulation induction therapy could improve live birth rates in overweight/obese PCOS women has not been illustrated. This research is aimed to evaluate whether CRD intervention prior to ovulation induction could promote reproductive health in overweight or obese PCOS women with fertility requirements and provide an evidence-based nutrition advice for clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •a diagnosis of polycystic ovary syndrome (PCOS) based on the Rotterdam diagnostic criteria;
- •age 20-35 years old;
- •a body-mass index over 23;
- •have requirements for fertility.
排除标准
- •acute or chronic viral hepatitis;
- •serious liver dysfunction or chronic kidney disease;
- •serious cardiovascular or cerebrovascular disease;
- •patients with a history of acute/chronic infection, severe cardiovascular and cerebrovascular diseases, and malignant tumors;
- •have drugs for PCOS such as glucocorticoids and anti-androgen drugs (spironolactone, cyproterone acetate, flutamide, etc.) within 3 months;
- •congenital or secondary uterine abnormalities;
- •use of medications that affect weight or energy balance such as Metformin within 3 months;
- •undergoing weight loss treatment (weight change greater than 5% in the past 3 months) or have a history of gastrointestinal surgery;
- •tubal obstruction;
- •the total number of motile sperm of male partner is less than 10 million;
- •any other situations that might affect the trial.
研究组 & 干预措施
CRD group
Patients in the calorie-restricted diet (CRD) group will have strict calorie-restriction diets for 8 weeks and then weight stability for 4 weeks.
干预措施: CRD (Behavioral)
Control group
Patients in the control group will receive regular diets and metformin 1500 mg daily for 12 weeks. Participants allocated to the control group are followed by the conventional approach (usual care) based on regular visits respecting the usual schedule dictated by the rules of general practice.
干预措施: Metformin (Drug)
结局指标
主要结局
Live birth during the period of ovulation induction
时间窗: 18 months
Live birth will be defined as the delivery of one or more living infants (≥22 week's gestation or birth weight more than 500g). The outcome could be assessed by clinical data and clinical diagnosis.
次要结局
- Oral glucose tolerance test (OGTT)(Baseline period and 3 months)
- Sex Hormone Binding Globulin (SHBG)(Baseline period and 3 months)
- Lean body weight(Baseline period and 3 months)
- Blood pressure (BP)(Baseline period and 3 months)
- Hospital Anxiety and Depression Scale (HADS)(Baseline period and 3 months)
- Blood lipid(Baseline period and 3 months)
- Kidney function index(Baseline period and 3 months)
- Liver function index(Baseline period and 3 months)
- Fasting blood glucose (FBG)(Baseline period and 3 months)
- Insulin release test (IRT)(Baseline period and 3 months)
- Free testosterone (FT)(Baseline period and 3 months)
- Weight(Baseline period and 3 months)
- Fasting insulin (FINS)(Baseline period and 3 months)
- Total testosterone (TT)(Baseline period and 3 months)
- Liver transient elastography(TE)(Baseline period and 3 months)
- Body Mass Index (BMI)(Baseline period and 3 months)
- Waist circumference(Baseline period and 3 months)
- Height(Baseline period and 3 months)
- Body fat(Baseline period and 3 months)
- Biochemical pregnancy(8 months)
- Ectopic pregnancy(8 months)
- Pregnancy failure(8 months)
- Birth weight(18 months)
- Neonatal complications(18 months)