Department of Obstetrics and Gynecology, Mansoura University, Mansoura, Egypt.
Gynecol Endocrinol. 2011 Mar;27(3):190-6. doi: 10.3109/09513590.2010.488771. Epub 2010 Jun 23.
To compare the effect of combined metformin-clomiphene citrate (CC) with highly purified urinary FSH (HP-uFSH) for ovulation induction in CC-resistant women with polycystic ovary syndrome (PCOS).
One-hundred fifty-three anovulatory women with CC-resistant PCOS were selected in this randomised controlled trial. Patients received combined metformin-CC (n=75, 205 cycles) or HP-uFSH (n=78, 186 cycles) for three cycles. Outcome measures were; Ovulation rate, number of growing and mature follicles, serum E2, serum P, endometrial thickness, pregnancy and miscarriage rates.
The ovulation rate per cycle was significantly higher in the HP-uFSH group (83.8% vs. 62%, p=0.01). The number of follicles ≥ 12 mm ≥ 14 mm and ≥ 18 mm on the hCG day was significantly greater in the HP-uFSH group (p=0.01, p=0.02 and p=0.03, respectively). Pregnancy occurred in 23/205 cycles (11.2%) in combined metformin-CC group and 40/186 cycles (21.5%) in the HP-uFSH group; the difference was statistically significant (p=0.02). Two patients in the HP-uFSH group suffered mild OHSS.
Combined metformin-CC resulted in modest ovulation and pregnancy rates without side effects. It is logical to offer this first for CC-resistant PCOS women before resorting to more expensive alternatives especially in developing communities where economic aspects of therapy are important.
比较二甲双胍联合枸橼酸氯米酚(CC)与高纯度尿促卵泡激素(HP-uFSH)对多囊卵巢综合征(PCOS)中 CC 抵抗患者促排卵的效果。
本随机对照试验纳入了 153 例 CC 抵抗的多囊卵巢综合征不孕患者。患者接受二甲双胍联合 CC(n=75,205 个周期)或 HP-uFSH(n=78,186 个周期)治疗,共 3 个周期。观察指标包括排卵率、生长卵泡和成熟卵泡数、血清 E2、血清 P、子宫内膜厚度、妊娠率和流产率。
HP-uFSH 组的周期排卵率显著更高(83.8%比 62%,p=0.01)。HCG 日≥12mm、≥14mm 和≥18mm 的卵泡数显著多于 CC 联合二甲双胍组(p=0.01、p=0.02 和 p=0.03)。CC 联合二甲双胍组的妊娠率为 23/205 个周期(11.2%),HP-uFSH 组为 40/186 个周期(21.5%),差异有统计学意义(p=0.02)。HP-uFSH 组有 2 例患者出现轻度 OHSS。
CC 联合二甲双胍可适度诱导排卵和妊娠,且无副作用。对于 CC 抵抗的 PCOS 患者,在选择更昂贵的替代方案之前,先使用这种方案是合理的,尤其是在治疗的经济方面很重要的发展中社区。