Physiological intracytoplasmic sperm injection (PICSI) did not significantly improve live birth rates compared with standard intracytoplasmic sperm injection (ICSI), and there was no difference between groups in either clinical pregnancy or premature birth, according to findings from a hyaluronic acid-binding sperm selection study published in The Lancet.
While the advent of ICSI has led to significant improvement in the treatment of male infertility, success rates have remained constant in the last decade, with live birth expected in approximately 25% of treated couples. Experts believe that hyaluronic acid, an organic polymer, may assist in selection of sperm with good DNA integrity and low aneuploidy rates. Previous studies have suggested that hyaluronan-based selection of sperm, or PICSI, may increase live birth rates and decrease miscarriage risk.
This study was the largest randomized trial of PICSI aiming to compare the efficacy of PICSI compared with standard ICSI for improving full-term (≥37 weeks’ gestational age) live birth rates. The study included patients treated at 16 assisted conception units in the United Kingdom. Eligible couples were recommended for ICSI procedure with fresh embryo transfer. Women were aged 18 to 43 years and men 18 to 55 years. Couples were randomly assigned 1:1 to undergo standard ICSI procedure or PICSI. The primary outcome was full-term live birth. Secondary outcomes included clinical pregnancy, miscarriage, and premature live birth.
Between February 2014 and August 2016, a total of 2772 couples were randomly assigned to receive PICSI (n = 1387) or standard ICSI (n = 1385); of these, 2752 (1381 and 1371 couples, respectively) were included in the primary analysis. Baseline and treatment characteristics were well balanced between the groups.
There was no significant difference in the full-term live birth rate between the PICSI (379/1381 couples; 27.4%) and ICSI (346/1371 couples; 25.2%) groups (odds ratio [OR] 1.12; 95% CI, 0.95-1.34; P =.18). In a similar fashion, there was no between-group difference in clinical pregnancy or premature live birth. However, in line with previous reports, there was a significant reduction in miscarriage with PICSI compared with standard ICSI (4.3% vs 7.0%, respectively; OR, 0.61; 95% CI, 0.43-0.84; P =.003), although the study was not powered to investigate this outcome.
While 56 serious adverse events were recorded during the study, there were no treatment-related adverse events in either group.
“[W]e can say with confidence that PICSI is not superior to standard ICSI for improving term live birth rates, despite the reduction in miscarriage. Wider in-service application of PICSI is therefore unjustified at this time,” concluded the researchers.
Miller D, Pavitt S, Sharma V, et al. Physiological, hyaluronan-selected intracytoplasmic sperm injection for infertility treatment (HABSelect): a parallel, two-group, randomised trial. Lancet. 2019;393(10170):416-422.