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Randomized Controlled Trial
. 2024 Sep 16:386:e080133.
doi: 10.1136/bmj-2024-080133.

Cumulative live birth rate of a blastocyst versus cleavage stage embryo transfer policy during in vitro fertilisation in women with a good prognosis: multicentre randomised controlled trial

Simone Cornelisse  1 , Kathrin Fleischer  2 , Lucette van der Westerlaken  3 , Jan-Peter de Bruin  4 , Carlijn Vergouw  5 , Carolien Koks  6 , Josien Derhaag  7 , Jantien Visser  8 , Jannie van Echten-Arends  9 , Els Slappendel  2 , Brigitte Arends  10 , Moniek van der Zanden  11 , Angelique van Dongen  12 , Janneke Brink-van der Vlugt  13 , Marcella de Hundt  14 , Max Curfs  15 , Harold Verhoeve  16 , Maaike Traas-Hofmans  17 , Yvonne Wurth  18 , Petra Manger  19 , Quirine Pieterse  20 , Didi Braat  21 , Madelon van Wely  22   23 , Liliana Ramos  21 , Sebastiaan Mastenbroek  22   23
Affiliations
Randomized Controlled Trial

Cumulative live birth rate of a blastocyst versus cleavage stage embryo transfer policy during in vitro fertilisation in women with a good prognosis: multicentre randomised controlled trial

Simone Cornelisse et al. BMJ. .

Abstract

Objectives: To evaluate whether embryo transfers at blastocyst stage improve the cumulative live birth rate after oocyte retrieval, including both fresh and frozen-thawed transfers, and whether the risk of obstetric and perinatal complications is increased compared with cleavage stage embryo transfers during in vitro fertilisation (IVF) treatment.

Design: Multicentre randomised controlled trial.

Setting: 21 hospitals and clinics in the Netherlands, 18 August 2018 to 17 December 2021.

Participants: 1202 women with at least four embryos available on day 2 after oocyte retrieval were randomly assigned to either blastocyst stage embryo transfer (n=603) or cleavage stage embryo transfer (n=599).

Interventions: In the blastocyst group and cleavage group, embryo transfers were performed on day 5 and day 3, respectively, after oocyte retrieval, followed by cryopreservation of surplus embryos. Analysis was on an intention-to-treat basis, with secondary analyses as per protocol.

Main outcome measures: The primary outcome was the cumulative live birth rate per oocyte retrieval, including results of all frozen-thawed embryo transfers within a year after randomisation. Secondary outcomes included cumulative rates of pregnancy, pregnancy loss, and live birth after fresh embryo transfer, number of embryo transfers needed, number of frozen embryos, and obstetric and perinatal outcomes.

Results: The cumulative live birth rate did not differ between the blastocyst group and cleavage group (58.9% (355 of 603) v 58.4% (350 of 599; risk ratio 1.01, 95% confidence interval (CI) 0.84 to 1.22). The blastocyst group showed a higher live birth rate after fresh embryo transfer (1.26, 1.00 to 1.58), lower cumulative pregnancy loss rate (0.68, 0.51 to 0.89), and lower mean number of embryo transfers needed to result in a live birth (1.55 v 1.82; P<0.001). The incidence of moderate preterm birth (32 to <37 weeks) in singletons was higher in the blastocyst group (1.87, 1.05 to 3.34).

Conclusion: Blastocyst stage embryo transfers resulted in a similar cumulative live birth rate to cleavage stage embryo transfers in women with at least four embryos available during IVF treatment.

Trial registration: International Clinical Trial Registry Platform NTR7034.

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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: support from Stichting Zorgevaluatie Nederland; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

Figures

Fig 1
Fig 1
Trial profile. IVF=in vitro fertilisation; OHSS=ovarian hyperstimulation syndrome
See this image and copyright information in PMC

Comment in

References

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