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Hum Reprod. 2017 Mar 1;32(3):485-491. doi: 10.1093/humrep/dex004.

Adjuncts in the IVF laboratory: where is the evidence for 'add-on' interventions?

Author information

1
Embryology, IVF and Reproductive Genetics, Institute for Women's Health, University College London, London, UK.
2
Law Department, London School of Economics and Political Science, London, UK.
3
Research Group Reproduction and Genetics, Vrije Universiteit Brussel, Laarbeeklaan 101, 1090 Brussels, Belgium.
4
Priority Research Centre for Reproductive Science, University of Newcastle, NSW, Australia.
5
Cambridge IVF, Cambridge University Hospitals NHS Trust, Cambridge, UK.
6
Rotunda Hospital and RCSI, Parnell Square, Dublin 1, Ireland.
7
Fertilitetscentrum, Carlanders Hospital, 402 29Gothenburg, Sweden.
8
Department of Reproductive Medicine, Central Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester M13 9WL, UK.
9
Institut de Parasitologie et Pathologie Tropicale, EA 7292, three rue Koeberlé, 67000 Strasbourg, France and Laboratoire de diagnostic génétique, UF3472-génétique de l'infertilité, Hôpitaux Universitaires de Strasbourg, 67000 Strasbourg, France.
10
Centre for Biostatistics, University of Manchester, Manchester Academic Health Science Centre, Manchester M13 9PL, UK.
11
Reproductive Medicine, Sahlgrenska University Hospital, Goteborg, Sweden.

Abstract

Globally, IVF patients are routinely offered and charged for a selection of adjunct treatments and tests or 'add-ons' that they are told may improve their chance of a live birth, despite there being no clinical evidence supporting the efficacy of the add-on. Any new IVF technology claiming to improve live birth rates (LBR) should, in most cases, first be tested in an appropriate animal model, then in clinical trials, to ensure safety, and finally in a randomized controlled trial (RCT) to provide high-quality evidence that the procedure is safe and effective. Only then should the technique be considered as 'routine' and only when applied to the similar patient population as those studied in the RCT. Even then, further pediatric and long-term follow-up studies will need to be undertaken to examine the long-term safety of the procedure. Alarmingly, there are currently numerous examples where adjunct treatments are used in the absence of evidence-based medicine and often at an additional fee. In some cases, when RCTs have shown the technique to be ineffective, it is eventually withdrawn from the clinic. In this paper, we discuss some of the adjunct treatments currently being offered globally in IVF laboratories, including embryo glue and adherence compounds, sperm DNA fragmentation, time-lapse imaging, preimplantation genetic screening, mitochondria DNA load measurement and assisted hatching. We examine the evidence for their safety and efficacy in increasing LBRs. We conclude that robust studies are needed to confirm the safety and efficacy of any adjunct treatment or test before they are offered routinely to IVF patients.

KEYWORDS:

IVF adjuncts; PGS; RCT; adherence compounds; assisted hatching; embryo glue; live-birth rate; mitochondria load; sperm DNA fragmentation; time-lapse imaging

PMID:
28158511
DOI:
10.1093/humrep/dex004
[Indexed for MEDLINE]

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