Sperm selection for assisted reproduction by prior hyaluronan binding: the HABSelect RCT
| Autor: | Jackson Kirkman-Brown, Sue Pavitt, Yacoub Khalaf, Sheena Lewis, Richard Hooper, Siladitya Bhattacharya, Arri Coomarasamy, Vinay Sharma, Daniel Brison, Gordon Forbes, Robert West, Allan Pacey, Kate Brian, Rachel Cutting, Virginia Bolton, David Miller |
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| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: | |
| Zdroj: | Efficacy and Mechanism Evaluation, Vol 6, Iss 1 (2019) |
| Druh dokumentu: | article |
| ISSN: | 2050-4365 2050-4373 |
| DOI: | 10.3310/eme06010 |
| Popis: | Background: Sperm selection for intracytoplasmic sperm injection (ICSI) has traditionally relied on standardised methods of sperm processing combined with subjective sperm selection (motility/morphology). In 2012, live birth rates (LBRs) stood at ≈24% per cycle started (32% per cycle reaching embryo transfer). Objective(s): The main clinical objective was to determine the benefits of a hyaluronan (HA)-based sperm selection process for physiological intracytoplasmic sperm injection (PICSI). A parallel, mechanistic objective evaluated sperm chromatin integrity and the potential of PICSI to compensate for poor sperm quality. Design: A Phase III, parallel-arm, blinded randomised controlled trial (RCT) of efficacy of PICSI versus ICSI alongside mechanistic evaluation. Setting: The RCT ran from February 2014 to August 2016, involving NHS (n = 14) and private (n = 2) UK hospital or satellite clinics. Mechanistic work was conducted in three university-based research laboratories and a partnering small–medium enterprise from June 2015 to December 2017. Participants: Couples undergoing an ICSI procedure using freshly ejaculated sperm with female partners aged between 18 and 43 years and male partners aged between 18 and 55 years. Intervention: Health and Care Professions Council-registered embryologists used the Medicines and Healthcare products Regulatory Agency-registered (HA-coated) PICSI™ dish (Origio, Måløv, Denmark) to select a single sperm for injection. Control couples received standard care. Main outcome measures: Clinical – the primary outcome was full-term live birth (≥ 37 weeks’ gestation). Secondary outcome measures were confirmed clinical pregnancy (CP), miscarriage following confirmation and preterm live birth ( |
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