OBJECTIVE To evaluate the efficacy and safety of highly purified human menotropin (HP-hMG) and recombinant follicle-stimulating hormone (rFSH) for controlled ovarian stimulation in a population of patients predicted to be high responders. DESIGN Randomized, open-label, assessor-blinded, parallel-group, noninferiority trial. SETTING Fertility centers. PATIENT(S) A total of 620 women with serum antimüllerian hormone (AMH) ≥5 ng/mL. INTERVENTION(S) Controlled ovarian stimulation with HP-hMG or rFSH in a GnRH antagonist assisted reproductive technology (ART) cycle. Fresh transfer of a single blastocyst was performed unless ovarian response was excessive, in which all embryos were cryopreserved. Subjects could undergo subsequent frozen blastocyst transfer within 6 months of randomization. MAIN OUTCOME MEASURE(S) Ongoing pregnancy rate (OPR) after fresh transfer (primary endpoint), as well as cumulative live birth, ovarian hyperstimulation syndrome (OHSS), and pregnancy loss rates. RESULTS OPR/cycle start after fresh transfer was 35.5% with HP-hMG and 30.7% with rFSH (difference: 4.7%, 95% CI -2.7%, 12.1%); noninferiority was established. Compared to rFSH, HP-hMG was associated with significantly lower OHSS (21.4% vs. 9.7% respectively; difference: -11.7%, 95% CI -17.3%, -6.1%) and cumulative early pregnancy loss rates (25.5% vs. 14.5% respectively; difference: -11.0%, 95% CI -18.8%, -3.14%). Despite 43 more transfers in the rFSH group, cumulative live birth rates were similar with HP-hMG and rFSH at 50.6% and 51.5% respectively (difference: -0.8%, 95% CI -8.7%, 7.1%). CONCLUSION(S) In high responders, HP-hMG provided comparable efficacy to rFSH with fewer adverse events, including pregnancy loss, suggesting its optimized risk/benefit profile in this population. CLINICAL TRIAL REGISTRATION NUMBER NCT02554279 (clinicaltrials.gov).

中文翻译：

---

在接受卵胞浆内单精子注射的高反应者中比较高纯度人促性腺激素和重组促卵泡激素的随机、评估者盲法试验

目的 评估高纯度人促性腺激素 (HP-hMG) 和重组促卵泡激素 (rFSH) 在预测为高反应者人群中用于受控卵巢刺激的有效性和安全性。设计 随机、开放标签、评估者盲法、平行组、非劣效性试验。设置生育​​中心。患者 共有 620 名血清抗苗勒管激素 (AMH) ≥ 5 ng/mL 的女性。干预在 GnRH 拮抗剂辅助生殖技术 (ART) 周期中使用 HP-hMG 或 rFSH 控制性卵巢刺激。除非卵巢反应过度，否则将进行单个囊胚的新鲜移植，其中所有胚胎都被冷冻保存。受试者可以在随机化后的 6 个月内进行后续的冷冻囊胚移植。主要结局指标 新移植后的持续妊娠率 (OPR)（主要终点），以及累积活产、卵巢过度刺激综合征 (OHSS) 和流产率。结果 新鲜转移后的 OPR/周期开始，HP-hMG 为 35.5%，rFSH 为 30.7%（差异：4.7%，95% CI -2.7%，12.1%）；非劣性成立。与 rFSH 相比，HP-hMG 与显着降低的 OHSS（分别为 21.4% 和 9.7%；差异：-11.7%、95% CI -17.3%、-6.1%）和累积早期妊娠丢失率（25.5% 对分别为 14.5%；差异：-11.0%，95% CI -18.8%，-3.14%）。尽管 rFSH 组中有 43 次以上的转移，但累积活产率与 HP-hMG 和 rFSH 相似，分别为 50.6% 和 51.5%（差异：-0.8%、95% CI -8.7%、7.1%）。结论（S）在高反应者中，HP-hMG 提供了与 rFSH 相当的疗效，并且不良事件更少，包括流产，这表明其在该人群中的风险/收益状况最佳。临床试验注册号 NCT02554279 (clinicaltrials.gov)。