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Lancet. 2019 Feb 2;393(10170):416-422. doi: 10.1016/S0140-6736(18)32989-1.

Physiological, hyaluronan-selected intracytoplasmic sperm injection for infertility treatment (HABSelect): a parallel, two-group, randomised trial.

Author information

1
Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds Laboratories, University of Leeds, Leeds, UK. Electronic address: d.miller@leeds.ac.uk.
2
Dental Translational and Clinical Research Unit, Leeds National Institute for Health Research Clinical Research Facility, University of Leeds, Leeds, UK.
3
The Leeds Centre for Reproductive Medicine, Seacroft Hospital, Leeds, UK.
4
Pragmatic Clinical Trials Unit, Centre for Primary Care and Public Health, Queen Mary University of London, London, UK.
5
School of Medicine, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.
6
Institute of Metabolism and Systems Research, College of Medical & Dental Sciences, University of Birmingham, Birmingham, UK; Birmingham Women's Hospital, Birmingham Women's and Children's National Health Service (NHS) Foundation Trust, Birmingham, UK.
7
Examen Ltd, Belfast, UK.
8
Sheffield Teaching Hospitals NHS Trust, Sheffield, UK.
9
Department of Reproductive Medicine, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Sciences Centre, St Mary's Hospital, Manchester, UK.
10
Department of Oncology & Metabolism, University of Sheffield, Sheffield, UK.
11
Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
12
Royal College of Obstetricians and Gynaecologists, London, UK.
13
School of Biosciences, University of Kent, Canterbury, UK.
14
Guy's and St Thomas' NHS Foundation Trust, Guy's Hospital, London, UK.

Abstract

BACKGROUND:

Sperm selection strategies aimed at improving success rates of intracytoplasmic sperm injection (ICSI) include binding to hyaluronic acid (herein termed hyaluronan). Hyaluronan-selected sperm have reduced levels of DNA damage and aneuploidy. Use of hyaluronan-based sperm selection for ICSI (so-called physiological ICSI [PICSI]) is reported to reduce the proportion of pregnancies that end in miscarriage. However, the effect of PICSI on livebirth rates is uncertain. We aimed to investigate the efficacy of PICSI versus standard ICSI for improving livebirth rates among couples undergoing fertility treatment.

METHODS:

This parallel, two-group, randomised trial included couples undergoing an ICSI procedure with fresh embryo transfer at 16 assisted conception units in the UK. Eligible women (aged 18-43 years) had a body-mass index of 19-35 kg/m2 and a follicle-stimulating hormone (FSH) concentration of 3·0-20·0 mIU/mL or, if no FSH measurement was available, an anti-müllerian hormone concentration of at least 1·5 pmol/L. Eligible men (aged 18-55 years) had not had a vasovasostomy or been treated for cancer in the 24 months before recruitment and were able, after at least 3 days of sexual abstinence, to produce freshly ejaculated sperm for the treatment cycle. Couples were randomly assigned (1:1) with an online system to receive either PICSI or a standard ICSI procedure. The primary outcome was full-term (≥37 weeks' gestational age) livebirth, which was assessed in all eligible couples who completed follow-up. This trial is registered, number ISRCTN99214271.

FINDINGS:

Between Feb 1, 2014, and Aug 31, 2016, 2772 couples were randomly assigned to receive PICSI (n=1387) or ICSI (n=1385), of whom 2752 (1381 in the PICSI group and 1371 in the ICSI group) were included in the primary analysis. The term livebirth rate did not differ significantly between PICSI (27·4% [379/1381]) and ICSI (25·2% [346/1371]) groups (odds ratio 1·12, 95% CI 0·95-1·34; p=0·18). There were 56 serious adverse events in total, including 31 in the PICSI group and 25 in the ICSI group; most were congenital abnormalities and none were attributed to treatment.

INTERPRETATION:

Compared with ICSI, PICSI does not significantly improve term livebirth rates. The wider use of PICSI, therefore, is not recommended at present.

FUNDING:

National Institute for Health Research Efficacy and Mechanism Evaluation Programme.

PMID:
30712901
PMCID:
PMC6409400
DOI:
10.1016/S0140-6736(18)32989-1
[Indexed for MEDLINE]
Free PMC Article

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