Evidence map›Paper›PMID 27855103›Full record

Trial reportBMJ open2016

Hyaluronic Acid Binding Sperm Selection for assisted reproduction treatment (HABSelect): study protocol for a multicentre randomised controlled trial.

K D Witt, L Beresford, S Bhattacharya, K Brian, A Coomarasamy, Rachel Cutting, R Hooper, J Kirkman-Brown, Y Khalaf, S E Lewis and 5 more

Erratum issuedAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
  6. Review
  7. Review
  8. Article
  9. Article
  10. Article
4 · The record

Corrections and comments

  • Erratum issued
    2017
5 · Who and what money

Authors and funding

15 authors.

K D WittDepartment: Centre for Primary Care & Public Health, Queen Mary University of London, London, UK.
L BeresfordDepartment: Centre for Primary Care & Public Health, Queen Mary University of London, London, UK.
S BhattacharyaSchool of Medicine and Dentistry, University of Aberdeen, Aberdeen, UK.
K BrianCharity Registration No. 1099960 (InfertilityNetworkUK), London, UK.
A CoomarasamyCentre for Human Reproductive Science, University of Birmingham, Birmingham Women's Fertility Centre, Birmingham Women's NHS Foundation Trust, Birmingham, UK.
Rachel CuttingLeeds Institute of Cardiovascular and Metabolic Medicine (LICAMM), University of Leeds, Leeds, UK.
R HooperDepartment: Centre for Primary Care & Public Health, Queen Mary University of London, London, UK.
J Kirkman-BrownCentre for Human Reproductive Science, University of Birmingham, Birmingham Women's Fertility Centre, Birmingham Women's NHS Foundation Trust, Birmingham, UK.
Y KhalafAssisted Conception Unit, Guy's and St Thomas's Hospital, London, UK.
S E LewisQueen's University Belfast, Institute of Pathology, Belfast, UK.
A PaceyDepartment of Human Metabolism, University of Sheffield, Sheffield, UK.
S PavittDental Translational and Clinical Research Unit, School of Dentistry, University of Leeds, Leeds, UK.
R WestLeeds Institute of Health Sciences, University of Leeds, Leeds, UK.
D MillerLeeds Institute of Cardiovascular and Metabolic Medicine (LICAMM), University of Leeds, Leeds, UK.ORCID 0000-0002-1709-108X
Rachel Cutting

Funding

Department of Health HCS SCL-2014-05-001Medical Research Council MC_PC_13092
6 · The paper itself

Abstract

introductionThe selection of a sperm with good genomic integrity is an important consideration for improving intracytoplasmic sperm injection (ICSI) outcome. Current convention selects sperm by vigour and morphology, but preliminary evidence suggests selection based on hyaluronic acid binding may be beneficial. The aim of the Hyaluronic Acid Binding Sperm Selection (HABSelect) trial is to determine the efficacy of hyaluronic acid (HA)-selection of sperm versus conventionally selected sperm prior to ICSI on live birth rate (LBR). The mechanistic aim is to assess whether and how the chromatin state of HA-selected sperm corresponds with clinical outcomes-clinical pregnancy rate (CPR), LBR and pregnancy loss (PL). METHODS AND ANALYSIS: Couples attending UK Centres will be approached, eligibility screening performed and informed consent sought. Randomisation will occur within 24 hours prior to ICSI treatment. Participants will be randomly allocated 1:1 to the intervention arm (physiological intracytoplasmic sperm injection, PICSI) versus the control arm using conventional methods (ICSI). The primary clinical outcome is LBR ≥37 weeks' gestation with the mechanistic study determining LBR's relationship with sperm DNA integrity. Secondary outcomes will determine this for CPR and PL. Only embryologists performing the procedure will be aware of the treatment allocation. Steps will be taken to militate against biases arising from embryologists being non-blinded. Randomisation will use a minimisation algorithm to balance for key prognostic variables. The trial is powered to detect a 5% difference (24-29%: p=0.05) in LBR ≥37 weeks' gestation. Selected residual sperm samples will be tested by one or more assays of DNA integrity. ETHICS AND DISSEMINATION: HABSelect is a UK NIHR-EME funded study (reg no 11/14/34; IRAS REF. 13/YH/0162). The trial was designed in partnership with patient and public involvement to help maximise patient benefits. Trial findings will be reported as per CONSORT guidelines and will be made available in lay language via the trial web site (http://www.habselect.org.uk/). TRIAL REGISTRATION NUMBER: ISRCTN99214271; Pre-results.

Indexed as

Birth RateHyaluronic AcidPregnancy OutcomeSpermatozoaAbortion, SpontaneousAdolescentAdultChromatinClinical ProtocolsDNAFemaleHumansMaleMiddle AgedPregnancyPregnancy RateChromatinDNAHyaluronic AcidREPRODUCTIVE MEDICINE

Identifiers

PMID27855103
PMCPMC5073628

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.