Effects of Structured Exercise Program Versus Hypocaloric Hyperproteic Diet on the Reproductive Function in Obese Anovulatory Infertile Patients With Polycystic Ovary Syndrome: a 24-Week Prospective Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pregnancy rate
研究概览
简要总结
Lifestyle modifications are successfully employed in polycystic ovarian syndrome (PCOS) improving menstrual cycles and fertility. Unfortunately, the compliance over the time is very low. Recently, we have showed a high adherence to structured exercise training (SET) program in women with PCOS. The current study will be aimed to compare the efficacy of the SET program with a diet program on the reproductive function in obese anovulatory infertile PCOS patients.
详细描述
Forty obese anovulatory infertile PCOS patients who wish to conceive will be allocated in two study-groups according to their desire: structured exercise training (SET) group (n. 20) will undergo a SET program, whereas diet group (n. 20) will undertake a hypocaloric hyperproteic diet. The duration of the study will be of 24 weeks. At baseline, after 12 and 24 weeks clinical, endocrine and metabolic evaluations will be performed in each patient and all reproductive events obtained throughout the study will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Anovulatory infertility
- •Obesity (BMI >30)
排除标准
- •Age <18 or >35 years
- •Neoplastic, metabolic, hepatic, renal, and cardiovascular disorders or other concurrent medical illnesses
- •Hypothyroidism, hyperprolactinemia, Cushing's syndrome, and non-classical congenital adrenal hyperplasia
- •Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other drugs know to affect sex hormone levels, carbohydrate metabolism, or appetite
- •Organic pelvic diseases, previous pelvic surgery, suspected peritoneal factor infertility, tubal or male factor infertility or sub-fertility
结局指标
主要结局
Pregnancy rate
时间窗: six months
次要结局
- Menstrual frequency(six months)
- Abortion rate(six months)
- Compliance(six months)