Does Short-term Structured Exercise Training Program Plus Diet Intervention Improve Ovarian Sensitivity to Clomiphene Citrate in Polycystic Ovary Syndrome Patients (PCOS)? A Prospective Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Ovulation rate
研究概览
简要总结
Clomiphene citrate (CC) is the first-line therapy for infertile women with polycystic ovary syndrome (PCOS). Unfortunately, at least 20% of PCOS results are not responsive to CC. Structured exercise training (SET) and diet has been successfully employed to restore ovarian function and to improve reproductive outcomes in obese and overweight women with PCOS. The current study was aimed to test the hypothesis that a short-term SET program plus diet intervention can improve the ovarian response to CC in CC-resistant PCOS patients.
详细描述
Ninety-six PCOS patients considered CC-resistant because not responsive to 150 mg daily of CC were randomized in three arms (group A, B, and C). Group A underwent SET program plus hypocaloric diet for two months, group B had one month of observation followed by one-cycle of CC therapy, and group C underwent SET program plus hypocaloric diet for two months and received one-cycle of CC for one cycle. CC was always given at the maximal dose previously used. Clinical, hormonal and metabolic data were assessed at baseline and after intervention. Ovulation was monitored by ultrasound and confirmed by plasma progesterone assay.
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
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Anovulation
排除标准
- •Major Medical Condition
- •Severe Obesity
研究组 & 干预措施
SET-diet plus clomiphene
Structured exercise program plus hypocaloric diet for two months and received one-cycle of clomiphene citrate for one cycle
干预措施: SET-diet plus clomiphene (Other)
Clomiphene citrate
One month of observation followed by one-cycle of clomiphene citrate therapy
干预措施: Clomiphene citrate (Drug)
SET plus diet
Lifestyle modifications for two months.
干预措施: Structured exercise program plus hypocaloric diet (Behavioral)
结局指标
主要结局
Ovulation rate
时间窗: three months
次要结局
- Clinical data(three months)
- Metabolic data(three months)