促性腺激素释放激素拮抗剂方案联合氯米芬对基础LH偏低不孕患者卵巢刺激效果：随机对照试验
Effects of progestin-primed ovarian stimulation protocol plus clomiphene citrate in patients with low basal LH levels: a randomized controlled trial
摘要
该前瞻性随机对照试验纳入230例基础LH<2.27 mIU/mL的不孕患者，比较hMG+甲羟孕酮（MPA）联合或不联合氯米芬（CC）的PPOS方案，主要终点为获卵率。结果显示，CC虽促进LH分泌，但联合组获卵率更低（0.71±0.22 vs 0.76±0.18，P=0.043），冻存胚胎数更少（2.89±2.43 vs 3.90±2.39），获卵数与卵母细胞利用率两组相近；累积临床妊娠率（61.05% vs 77.67%）与累积活产率（53.68% vs 66.02%）差异无统计学意义。结论提示基础LH偏低患者使用含CC的PPOS方案应谨慎。
原文摘要
BACKGROUND: Infertile patients with low basal luteinizing hormone (LH) levels have low oocyte retrieval rate, but whether progestin-primed ovarian stimulation (PPOS) protocol with clomiphene citrate (CC) could enhance oocyte retrieval rate in these patients remains unclear. METHODS: This prospective randomized controlled trial was performed between January 2018 and February 2021, included 230 infertile patients with low basal LH levels (LH < 2.27 mIU/mL). In study group, 115 patients received human menopausal gonadotropin (hMG) 150 or 225 IU/d + CC 50 mg/d + medroxyprogesterone acetate (MPA) 10 mg/d from the third day of menstruation. In control group, 115 patients received hMG 150 or 225 IU/d + MPA 10 mg/d from the third day of menstruation. Viable embryos were cryopreserved for later transfer. The primary outcome measure was the oocyte retrieval rate. RESULTS: CC contributed to LH secretion. The hMG+MPA+CC group showed a decreased oocyte retrieval rate (0.71 ± 0.22 vs. 0.76 ± 0.18, mean difference (MD) -0.06 (-0.11 to -0.01); P = 0.043) and a decreased number of cryopreserved embryos (2.89 ± 2.43 vs. 3.90 ± 2.39, MD -0.89 (-1.50 to -0.28); FDR-P = 0.035). Two groups had similar number of retrieved oocytes (8.83 ± 5.41 vs. 10.69 ± 5.85, MD -0.99 (-2.27 to 0.29); FDR-P = 0.213) and oocyte utilization rate (0.40 ± 0.25 vs. 0.46 ± 0.24, MD -0.07 (-0.14 to -0.01); FDR-P = 0.084). Two groups had comparable cumulative clinical pregnancy rates (61.05% vs. 77.67%, hazard ratio (HR) 0.74 (0.53 to 1.06); P = 0.101; FDR-P = 0.214) and cumulative live birth rates (53.68% vs. 66.02%, HR 0.77 (0.53 to 1.13); P = 0.183; FDR-P = 0.214). CONCLUSIONS: CC contributed to LH secretion, but PPOS protocol with CC resulted in a lower oocyte retrieval rate in patients with low basal LH levels. PPOS protocol with CC should be used cautiously in these patients. TRIAL REGISTRATION: ChiCTR number: ChiCTR1800014440. URL: https://www.chictr.org.cn/showproj.html?proj=24573. Date of registration: 2018/01/13. Date of enrollment of the first subject: 2018/1/17.
推荐理由：针对基础LH偏低这一易被忽视的亚组，用RCT直接检验PPOS加CC的获益假设，并给出阴性结果，对临床促排卵方案选择有直接警示价值；设计规范、终点明确，但为单中心、样本量中等，机制阐释有限。
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