目的：在一项随机临床试验（PURSUE）中，研究冻融胚胎移植（FTET）周期的有效性和安全性。
方法：随访临床研究。
方法：体外受精（IVF）中心。
方法：35至42岁的不孕妇女。
方法：在PURSUE中，在促性腺激素释放激素(GnRH)拮抗剂方案中,在控制性卵巢刺激(COS)的前7天,我们将女性随机分为单次注射150μg的Corifollitropinalfa(n=694)或每日300IU的重组卵泡刺激素(重组FSH;n=696).
方法：治疗组每位患者的累积生命妊娠率，按治疗组划分的每位患者累积活产率，（怀孕）妇女及其胎儿/婴儿的不良事件发生以及婴儿先天性畸形的发生率。
结果：在受PURSUE治疗的1,390名妇女中，307人参加了FTET研究。在PURSUE或随后的FTET周期中，累积重要妊娠率（每位患者）为31.1％（95％置信区间[CI]，27.7％；34.7％）与重组FSH的33.0％（95％CI：29.6％；36.7％）；治疗差异，-1.8%（95%CI，-6.5%；3.0%），和累积活产率（每位患者）为28.2％（95％CI，24.9％；31.8％）与重组FSH的29.5％（95％CI，26.1％；33.0％）；治疗差异，-1.2%（95%CI，-5.7%；3.4%）。从孕妇或其婴儿中收集的安全结局没有临床相关差异，这些孕妇或其婴儿移植了通过使用抗衰老素或重组FSH治疗获得的冷冻保存胚胎。
结论：在使用抗衰老素和重组FSH治疗的妇女中，累积重要妊娠率和活产率（来自新鲜周期和FTET）相似。在这项随访FTET研究中未检测到新的安全性信号。
背景：NCT01146418。
OBJECTIVE: To examine the efficacy and safety of frozen-thawed embryo transfer (FTET) cycles with supernumerary embryos cryopreserved during a randomized clinical
trial (PURSUE).
METHODS: Follow-up clinical
study.
METHODS: In vitro fertilization (IVF) centers.
METHODS: Infertile women 35 to 42 years of age.
METHODS: In PURSUE, women were randomized to a single injection of 150 μg of corifollitropin alfa (n = 694) or daily 300 IU of recombinant follicle-stimulating hormone (recombinant FSH; n = 696) for the first 7 days of controlled ovarian stimulation (COS) in a gonadotropin-releasing hormone (GnRH) antagonist protocol.
METHODS: Cumulative vital pregnancy rate per-patient by treatment group, cumulative live-birth rate per-patient by treatment group, and occurrence of adverse events in (pregnant) women and their fetuses/infants and the incidence of congenital malformations in the infants.
RESULTS: Of the 1,390 treated women in PURSUE, 307 were enrolled in the FTET
study. In PURSUE or a subsequent FTET cycle, the cumulative vital pregnancy rate (per patient) was 31.1% (95% confidence interval [CI], 27.7%; 34.7%) with corifollitropin alfa versus 33.0% (95% CI: 29.6%; 36.7%) with recombinant FSH; treatment difference, -1.8% (95% CI, -6.5%; 3.0%), and the cumulative live-birth rate (per patient) was 28.2% (95% CI, 24.9%; 31.8%) with corifollitropin alfa versus 29.5% (95% CI, 26.1%; 33.0%) with recombinant FSH; treatment difference, -1.2% (95% CI, -5.7%; 3.4%). There were no clinically relevant differences in safety outcomes collected from pregnant women or their infants after transfer of cryopreserved embryos obtained by treatment with corifollitropin alfa or recombinant FSH.
CONCLUSIONS: The cumulative vital pregnancy and live-birth rates (from fresh cycles and FTET) were similar in women treated with corifollitropin alfa and recombinant FSH. No new safety signals were detected in this follow-up FTET
study.
BACKGROUND: NCT01146418.
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