Introduction The 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.
- REPRODUCTIVE MEDICINE
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Contributors KDW and DM designed and wrote the protocol. SP provided expert assistance on trial design and management. JK-B, SEL and AP provided expert assistance on the application of laboratory methods. RH and RW provided essential statistical support on clinical and mechanistic aspects of the study, respectively. YK, AC and SB provided expert clinical support and checked the protocol for accuracy. LB designed the clinical statistical analysis plan. KB is our Patient & Public Involvement Contributor.
Funding This project is funded by the Efficacy and Mechanism Evaluation (EME) Programme, an MRC and NIHR partnership. This work is supported by the UK National Institute for Health Research (ISRCTN No. 99214271; MREC No. 13/YH/0162; UKCRN ID 14845).
Competing interests The authors declare that they have no competing interests.
Disclaimer The views expressed in this publication are those of the author(s) and not necessarily those of the MRC, NHS, NIHR or the Department of Health.
Patient consent Obtained.
Ethics approval IRAS.
Provenance and peer review Not commissioned; externally peer reviewed.
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