甲磺酸溴隐亭辅助克罗米芬诱导多囊卵巢综合征不孕患者排卵的随机、开放、对照临床研究

Induction of ovulation with clomiphene combined with bromocriptine in polycystic ovary syndrome patients with infertility: a prospective, randomized, controlled clinical trial

目的研究多巴胺激动剂溴隐亭(BCT)联合克罗米芬(CC)对多囊卵巢综合征(PCOS)合并不孕患者促排卵助孕的疗效。方法本研究为随机、开放、对照试验,在上海2家医院共收集PCOS合并不孕患者100例,随机分为对照组和试验组,对照组在月经周期3~7 d给予CC 50 mg/d,试验组在此基础上同时全周期给予BCT 2.5 mg/d,两组均治疗1个周期。在月经第3日、hCG注射日、hCG注射第7日抽血化验激素水平,包括促卵泡激素(FSH)、促黄体生成素(LH)、催乳素(PRL)、雌二醇(E_2)、总睾酮(T)、孕激素(P),并行阴道超声测定子宫内膜厚度、卵泡大小、数量。结果两组的基础激素水平无统计学差异。对照组和试验组的促排卵成功率分别为72.0%和75.4%(P>0.05),试验组的持续妊娠率(18.4%)明显高于对照组(8.0%)。hCG注射日的FSH、E_2、P水平无统计学差异,LH水平有所降低,PRL和T显著降低(分别为P=0.00,P=0.00);hCG注射第7日的E_2、P水平无统计学差异,PRL显著下降,试验组的子宫内膜厚度[(10.20±1.92)mm]明显高于对照组[(9.22±1.88)mm](P=0.01)。结论 BCT联合CC可以提高PCOS患者促排卵的助孕成功率,降低PRL、LH、T水平并增加着床窗口期的子宫内膜厚度。提示多巴胺激动剂BCT可能通过降低垂体激素及雄激素水平、降低子宫内膜血管阻力并增加内膜血供改善PCOS不孕患者的助孕结局。

Objective To compare the effects of bromocriptine（BCT） combined with clomiphene citrate（CC）on the outcome of ovulation-induction in patients with polycystic ovary syndrome（PCOS）. Methods A prospective,randomized, controlled clinical trial was performed on 100 PCOS patients with infertility. Patients were randomly divided into two groups, control group received 50 mg CC from day 3 to day 7, test group（CC＋ BCT） was given 50 mg of CC from day 3 to day 7 along with 2.5 mg of BCT daily for full cycle. Both the groups were treated for one cycle.Results The outcomes were measured by the hormonal status, follicular size, endometrial thickness, ovulation rate, and pregnancy outcomes. The baseline level of hormones between the two groups was not different before treatment. After intervention, the rate of ovulation in CC group was 72.0% and in CC＋ BCT group was 75.4%（P〉0.05）, the rate of ongoing pregnancy in CC＋ BCT group（18.4%） was higher than that in CC group（8.0%）. On hCG injection day, there were no statistically significant differences between two groups regarding to levels of follicle-stimulating hormone（FSH）, estradiol（E2） and progesterone（P）, but prolactin（PRL） and testosterone（T） was significantly decreased（respectively P=0.000,P=0.004）, and LH level was also decreased but with no statistical significance（P=0.094）. On hCG injection day 7, levels of P and E2 were not different between the two groups（respectively P=0.901, P=0.192）, but PRL level was decreased（P=0.000） and the endometrial thickness was increased significantly（P=0.017）. Conclusion Our results showed that BCT plus CC can improve the outcome of ovulation-induction of PCOS patients, reducing levels of PRL, LH and T, and increasing the endometrial thickness of embryo implantation time. It can be concluded that use of BCT with CC improve the outcome of ovulation-induction more than use of CC alone for infertile PCOS patients, which may be brought about through dopamine agonists efficacy in reducing LH and PRL levels, vascular resistance and increasing uterine blood supply to the uterus.