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Randomized Controlled Trial
. 2025 Jan 29:388:e081474.
doi: 10.1136/bmj-2024-081474.

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

Daimin Wei  1   2   3   4 , Yun Sun  5   6 , Han Zhao  1   2   3   4 , Junhao Yan  1   2   3   4 , Hong Zhou  7 , Fei Gong  8 , Aijun Zhang  9 , Ze Wang  1   2   3   4 , Lei Jin  10 , Hongchu Bao  11 , Shuyun Zhao  12 , Zhuoni Xiao  13 , Yingying Qin  1   2   3   4 , Ling Geng  1   2   3   4 , Linlin Cui  1   2   3   4 , Yan Sheng  1   2   3   4 , Mei Sun  1   2   3   4 , Peihao Liu  1   2   3   4 , Lingling Ding  1   2   3   4 , Hong Liu  1   2   3   4 , Keliang Wu  1   2   3   4 , Yan Li  1   2   3   4 , Yao Lu  5   6 , Bufang Xu  9 , Bei Xu  10 , Luqing Zhang  11 , Heping Zhang  14 , Richard S Legro  15 , Zi-Jiang Chen  16   2   3   4   5   6
Affiliations
Randomized Controlled Trial

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

Daimin Wei et al. BMJ. .

Abstract

Objective: To test the hypothesis that a freeze-all strategy would increase the chance of live birth compared with fresh embryo transfer in women with low prognosis for in vitro fertilisation (IVF) treatment.

Design: Pragmatic, multicentre, randomised controlled trial.

Setting: Nine academic fertility centres in China.

Participants: 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).

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

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

Results: In an intention-to-treat analysis, 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 interval 0.65 to 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)). 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)). No difference was observed in birth weight, incidence of obstetric complications, or risk of neonatal morbidities.

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. 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.

Trial registration: Chinese Clinical Trial Registry ChiCTR2100050168.

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Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: RSL reports consulting for Organon, Celmatix and Exeltis. All other authors declare no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; and no other relationships or activities that could appear to have influenced the submitted work.

Figures

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Trial profile
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