一项比较高反应者接受胞浆内单精子注射时使用高纯人促性腺激素和重组卵泡刺激素的随机、评估者设盲试验。
Randomized, assessor-blinded trial comparing highly purified human menotropin and recombinant follicle-stimulating hormone in high responders undergoing intracytoplasmic sperm injection.
机构信息
Houston Fertility Institute, Houston, Texas.
Ferring Pharmaceuticals, Inc., Parsippany, New Jersey.
出版信息
Fertil Steril. 2020 Aug;114(2):321-330. doi: 10.1016/j.fertnstert.2020.03.029. Epub 2020 May 13.
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).
目的
评估高纯度人促性腺激素（HP-hMG）和重组卵泡刺激素（rFSH）在预测为高反应者的人群中进行控制性卵巢刺激的疗效和安全性。
设计
随机、开放标签、评估者设盲、平行组、非劣效性试验。
设置
生育中心。
患者
共 620 名血清抗苗勒管激素（AMH）≥5ng/mL 的妇女。
干预措施
在 GnRH 拮抗剂辅助生殖技术（ART）周期中使用 HP-hMG 或 rFSH 进行控制性卵巢刺激。除非卵巢反应过度，否则进行单个囊胚的新鲜移植，否则所有胚胎均冷冻保存。受试者可以在随机分组后 6 个月内进行随后的冷冻囊胚移植。
主要观察指标
新鲜移植后的持续妊娠率（OPR）（主要终点），以及累积活产率、卵巢过度刺激综合征（OHSS）和妊娠丢失率。
结果
新鲜移植后 OPR/周期开始率分别为 HP-hMG 组 35.5%和 rFSH 组 30.7%（差异：4.7%，95%CI-2.7%，12.1%）；证实了非劣效性。与 rFSH 相比，HP-hMG 与明显较低的 OHSS 发生率相关（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（分别为 25.5%和 14.5%；差异：-11.0%，95%CI-18.8%，-3.14%）。尽管 rFSH 组有 43 次更多的转移，但 HP-hMG 和 rFSH 的累积活产率分别为 50.6%和 51.5%，相似（差异：-0.8%，95%CI-8.7%，7.1%）。
结论
在高反应者中，HP-hMG 与 rFSH 具有相当的疗效，且不良事件较少，包括妊娠丢失，这表明其在该人群中的风险/效益比更优。
临床试验注册号
NCT02554279（clinicaltrials.gov）。
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