Unit of Reproductive Medicine and Surgery, Department of Obstetrics & Gynaecology, University Magna Graecia of Catanzaro, Viale Europa Catanzaro, Italy.
Hum Reprod. 2010 Nov;25(11):2783-91. doi: 10.1093/humrep/deq254. Epub 2010 Sep 21.
Clomiphene citrate (CC) is the first-line therapy for the induction of ovulation in infertile women with polycystic ovary syndrome (PCOS), but ∼20% of patients are unresponsive. The aim of the current study was to test the hypothesis that a 6-week intervention that consisted of structured exercise training (SET) and hypocaloric diet increases the probability of ovulation after CC in overweight and obese CC-resistant PCOS patients.
A cohort of 96 overweight and obese CC-resistant PCOS patients was enrolled consecutively in a three-arm randomized, parallel, controlled, assessor-blinded clinical trial. The three interventions were: SET plus hypocaloric diet for 6 weeks (Group A); 2 weeks of observation followed by one cycle of CC therapy (Group B); and SET plus hypocaloric diet for 6 weeks, with one cycle of CC after the first 2 weeks (Group C). The primary end-point was the ovulation rate. Other reproductive data, as well as anthropometric, hormonal and metabolic data, were also collected and considered as secondary end points.
After 6 weeks of SET plus hypocaloric diet, the ovulation rate was significantly (P =0.008) higher in Group C [12/32 (37.5%)] than in Groups A [4/32 (12.5%)] and B [3/32 (9.4%)] with relative risks of 3.9 [95% confidence interval (CI) 1.1-8.3; P = 0.035] and 4.0 (95% CI 1.2-12.8; P = 0.020) compared with Groups A and B, respectively. Compared with baseline, in Groups A and C, a significant improvement in clinical and biochemical androgen and insulin sensitivity indexes was observed. In the same two groups, the insulin sensitivity index was significantly (P < 0.05) better than that in Group B.
In overweight and obese CC-resistant PCOS patients, a 6-week intervention of SET and a hypocaloric diet was effective in increasing the probability of ovulation under CC treatment. The study was registered at Clinicaltrials.gov:NCT0100468.
枸橼酸氯米酚（CC）是治疗多囊卵巢综合征（PCOS）不孕妇女排卵诱导的一线药物，但约 20%的患者无反应。本研究的目的是检验以下假设，即 6 周的结构化运动训练（SET）和低热量饮食干预可增加超重和肥胖的 CC 抵抗型 PCOS 患者在 CC 治疗后排卵的可能性。
连续纳入 96 例超重和肥胖的 CC 抵抗型 PCOS 患者，进行三臂随机、平行、对照、评估者盲法临床试验。三组干预措施如下：6 周 SET 加低热量饮食（A 组）；2 周观察，然后进行一个周期的 CC 治疗（B 组）；6 周 SET 加低热量饮食，前 2 周后进行一个周期的 CC（C 组）。主要终点是排卵率。还收集了其他生殖数据以及人体测量、激素和代谢数据，并将其作为次要终点。
6 周 SET 加低热量饮食后，C 组（12/32，37.5%）的排卵率明显高于 A 组（4/32，12.5%）和 B 组（3/32，9.4%）（P =0.008），相对风险分别为 3.9（95%可信区间为 1.1-8.3；P = 0.035）和 4.0（95%可信区间为 1.2-12.8；P = 0.020）。与基线相比，A 组和 C 组的临床和生化雄激素和胰岛素敏感性指标均显著改善。在这两组中，胰岛素敏感性指数明显优于 B 组（P <0.05）。
在超重和肥胖的 CC 抵抗型 PCOS 患者中，6 周的 SET 和低热量饮食干预可有效提高 CC 治疗下排卵的可能性。该研究在 Clinicaltrials.gov 注册，编号为 NCT0100468。
