Frozen versus fresh embryo transfer in women with low prognosis for in vitro fertilisation treatment: pragmatic, multicentre, randomised controlled trial.

Methods

Pragmatic, multicentre, randomised controlled trial.

实用的、多中心的、随机对照试验。

Nine academic fertility centres in China.

中国九家学术生育中心。

838 women with a low prognosis for IVF treatment defined by ≤9 oocytes retrieved or poor ovarian reserve (antral follicle count <5 or serum anti-Müllerian hormone level <8.6 pmol/L).

838名女性，根据≤9个卵子回收或卵巢储备差（窦卵泡计数<5或血清抗苗勒管激素水平<8.6 pmol/L）定义为IVF治疗预后不良。

Eligible participants were randomised (1:1) to undergo either frozen embryo transfer or fresh embryo transfer on the day of oocyte retrieval. Participants in the frozen embryo transfer group had all of their embryos cryopreserved and underwent frozen embryo transfer later.

符合条件的参与者被随机分配（1:1），在卵子提取当天进行冷冻胚胎移植或新鲜胚胎移植。冷冻胚胎移植组的参与者将所有胚胎冷冻保存，并在以后进行冷冻胚胎移植。

Participants in the fresh embryo transfer group underwent fresh embryo transfer after oocyte retrieval.

新鲜胚胎移植组的参与者在卵子提取后进行了新鲜胚胎移植。

The primary outcome was live birth, defined as the delivery of neonates with a heartbeat and respiration at ≥28 weeks' gestation.

主要结果是活产，定义为在≥28周妊娠时有心跳和呼吸的新生儿的分娩。

Secondary outcomes were clinical pregnancy, singleton or twin pregnancy, pregnancy loss, ectopic pregnancy, birth weight, maternal and neonatal complications, and cumulative live birth after embryo transfers within one year after randomisation.

次要结果包括临床妊娠、单胎或双胎妊娠、妊娠丢失、异位妊娠、出生体重、母婴并发症以及随机化后一年内胚胎移植后的累积活产。

Results

In an intention-to-treatanalysis, the rate of live birth was lower in the frozen embryo transfer group than in the fresh embryo transfer group (32% (132 of 419) v 40% (168 of 419); relative ratio 0.79 (95% confidence interval0.65 to 0.94); P=0.009).

在意向治疗分析中，冻胚移植组的活产率低于新鲜胚胎移植组（32%（132/419）对比40%（168/419）；相对比率0.79（95%置信区间0.65至0.94）；P=0.009）。

The frozen embryo group had a lower rate of clinical pregnancy than the fresh embryo group (39% (164 of 419) v 47% (197 of 419); 0.83 (0.71 to 0.97)).

冻胚组的临床妊娠率低于新鲜胚胎组（39%（164/419）对比47%（197/419）；0.83（0.71至0.97））。

The cumulative live birth rate was lower in the frozen embryo transfer group compared with the fresh embryo transfer group (44% (185 of 419) v 51% (215 of 419), 0.86 (0.75 to 0.99)).

与新鲜胚胎移植组相比，冷冻胚胎移植组的累积活产率较低（44%（185/419）对比51%（215/419），相对风险为0.86（95%置信区间0.75至0.99））。

No difference was observed in birth weight, incidenceof obstetric complications, or risk of neonatal morbidities.

在出生体重、产科并发症发生率或新生儿疾病风险方面未观察到差异。

Conclusions

Fresh embryo transfer may be a better choice for women with low prognosis in terms of live birth rate compared with a freeze-all strategy.

与全冻存策略相比，新鲜胚胎移植可能是低活产率预后女性更好的选择。

The treatment strategies that prevent fresh embryo transfers, such as accumulating embryos with back-to-back cycles or performing routine preimplantation genetic testing for aneuploidy, warrant further studies in women with a low prognosis.

那些防止新鲜胚胎移植的治疗策略，如连续周期累积胚胎或常规进行胚胎植入前的染色体非整倍体检测，需要在低预后女性中进行进一步研究。

trial_registration

Chinese Clinical Trial Registry ChiCTR2100050168.

中国临床试验注册中心ChiCTR2100050168。