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A fast and safe technique for sperm preparation in ICSI treatments within a randomized controlled trial (RCT).

ABSTRACT: Recently a novel method based on horizontal sperm migration in injection dishes has been introduced as an additional tool for preparation of semen sample in assisted reproductive technology (ART) procedures. In the present study, we evaluated both timing and reproductive outcomes in a randomized controlled study including 1034 intra-cytoplasmic sperm injection (ICSI) procedures followed by fresh embryo transfer. Couples enrolled were divided into two sub-groups, namely conventional swim-up method (Group A), and horizontal sperm migration in injection dishes (Group B).No significant differences were found between groups with respect to fertilization rate, implantation success, clinical pregnancy outcomes and ongoing pregnancies. On the contrary, both cleavage and blastocyst rates were statistically higher in Group B, suggesting superior efficiency and safety of this innovative technique also including time-saving and cheaper costs as compared to the classical swim-up sperm preparation.Our data support the interpretation of the horizontal sperm migration as a promising procedure for semen preparation in ART cycles.

SUBMITTER: Baldini D

PROVIDER: S-EPMC7437070 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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A fast and safe technique for sperm preparation in ICSI treatments within a randomized controlled trial (RCT).

Baldini Domenico D Baldini Annamaria A Silvestris Erica E Vizziello Giovanni G Ferri Daniele D Vizziello Damiano D

Reproductive biology and endocrinology : RB&E 20200819 1

Recently a novel method based on horizontal sperm migration in injection dishes has been introduced as an additional tool for preparation of semen sample in assisted reproductive technology (ART) procedures. In the present study, we evaluated both timing and reproductive outcomes in a randomized controlled study including 1034 intra-cytoplasmic sperm injection (ICSI) procedures followed by fresh embryo transfer. Couples enrolled were divided into two sub-groups, namely conventional swim-up metho ...[more]

PMID: 32814589

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Project description:INTRODUCTION:Intracytoplasmic sperm injection (ICSI), originally introduced as add-on to in vitro fertilisation (IVF) for couples with severe male infertility, is in current clinical practice also used in couples with mild male or even unexplained infertility. However, ICSI has involved unresolved concerns regarding the selection and damage to gametes and the health conditions of the offspring, and it is also labour intensive and therefore more expensive than conventional IVF. High-quality well-powered randomised clinical trials (RCTs) comparing ICSI and IVF are lacking. METHODS AND ANALYSIS:We propose a multicentre, open-label RCT in 10 reproductive medical centres across China. We will study couples with non-severe male infertility (defined as a semen concentrate 5-15×106/mL or sperm with a progressive motility 10%-32%) scheduled for their first or second ICSI or IVF cycle, as low fertility rate after fertilisation are more frequent in this population, which could lead to controversy about ICSI or conventional IVF for fertilisation. On the day of oocyte retrieval, eligible participants are after informed consent be randomised to undergo either ICSI or conventional IVF in a 1:1 treatment ratio. Other standard assisted reproductive treatments are similar and parallel between two groups. Our primary outcome is ongoing pregnancy leading to live birth after the first cycle with embryo transfer. To demonstrate or refute a difference of 7% between ICSI and conventional IVF, we need to include 2346 women (1173 in each intervention arm). In addition, we will follow-up neonatal outcomes after delivery to identify the influence of ICSI on offspring. ETHICS AND DISSEMINATION:Ethical approval was obtained from Peking University Third Hospital medical science research ethics committee. The findings will be disseminated to the public through conference presentations and peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov registry (NCT03298633).

Project description:ObjectiveTo explore the clinical application value of half-ICSI treatment for infertility in assisted reproductive technology.MethodA retrospective analysis of 1130 half-ICSI treatments was conducted at the Affiliated Reproductive Hospital of Shandong University from January 2011 to December 2015. Patients with low fertilization rates in previous cycles, primary infertility for >5 years with unexplained reason, or secondary infertility for >5 years without fallopian tube factor were involved in this study. The 2PN rate, high-quality embryo rate, oocyte utilization rate, and clinical outcomes were compared between IVF insemination group (IVF group) and ICSI insemination group (ICSI group). The clinical outcome of half-ICSI insemination treatment, grouped according primary and secondary infertility, was also analyzed.ResultsCompared with IVF, ICSI resulted in a significantly higher 2PN rate (74.8% vs. 62.9%), high-quality embryo rate (54.6% vs. 51.7%), and oocyte utilization rate (35.9% vs. 32.8%; P<0.05). Among the 884 fresh-embryo transfer cycles, there were no notable differences in clinical pregnancy rate, live birth rate, or neonatal abnormality rate between the IVF and ICSI groups. Among the 792 primary infertility cycles, ICSI resulted in a significantly higher 2PN rate, high-quality embryo rate, and oocyte utilization rate compared with IVF (75.3% vs. 62.4%, 54.3% vs. 50.8%, 36.4% vs. 32.6%, P<0.05). For the 338 secondary infertility cycles, ICSI resulted in a significantly higher 2PN rate (73.6% vs. 63.9%, P<0.05) compared with IVF, but there were no notable differences in other laboratory results. Moreover, the biochemical pregnancy rate of the ICSI group was significantly lower than for IVF in secondary infertility cycles (49.3% vs. 65.6%; P<0.05). A total of 89 cycles (7.9%) with complete IVF fertilization failure showed a low second polar body (2PB) rate (33.6%) after a 5-h short-time fertilization period, including 34 cycles (3.0%) with no 2PB oocytes observed in the IVF group.ConclusionICSI insemination improved laboratory results compared with IVF insemination, however, fresh-embryo transfer of ICSI originated embryos did not improve clinical pregnancy and live birth rates. Rescue ICSI has been successfully applied in clinical IVF insemination to avoid fertilization failure. Therefore, as an extra intervention, it is suggested that ICSI be used judiciously.

Project description:BackgroundSubfertility is a condition found in up to 15% of couples of reproductive age. Gamete micromanipulation, such as intracytoplasmic sperm injection (ICSI), is very useful for treating couples with compromised sperm parameters. An alternative method of sperm selection has been described; the spermatozoa are selected under high magnification (over 6000x) and used for ICSI. This technique, named intracytoplasmic morphologically selected sperm injection (IMSI), has a theoretical potential to improve reproductive outcomes among couples undergoing assisted reproduction techniques (ART). However, our previous version of this Cochrane Review was unable to find evidence that supported this possible beneficial effect. This is an update of Teixeira 2013.ObjectivesTo identify, appraise, and summarise the available evidence regarding efficacy and safety of IMSI compared to ICSI in couples undergoing ART.Search methodsWe searched for randomised controlled trials (RCTs) in these electronic databases: the Cochrane Gynaecology and Fertility Group Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, LILACS, and in these trial registers: ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform. We also handsearched the reference lists of included studies and similar reviews. We performed the last electronic search on 18 November 2019.Selection criteriaWe only considered RCTs that compared ICSI and IMSI; we did not include quasi-randomised trials. We considered studies that permitted the inclusion of the same participant more than once (cross-over or per cycle trials) only if data regarding the first treatment of each participant were available.Data collection and analysisTwo review authors independently performed study selection, data extraction, and assessment of the risk of bias and quality of the evidence; we solved disagreements by consulting a third review author. We corresponded with study investigators to resolve any queries, as required.Main resultsThe updated search retrieved 535 records; we included 13 parallel-designed RCTs comparing IMSI and ICSI (four studies were added since the previous version), comprising 2775 couples (IMSI = 1256; ICSI = 1519). We are uncertain if IMSI improves live birth rates (risk ratio (RR) 1.11, 95% confidence interval (CI) 0.89 to 1.39; 5 studies, 929 couples; I² = 1%), miscarriage rates per couple (RR 1.07, 95% CI 0.78 to 1.48; 10 studies, 2297 couples; I² = 0%, very-low quality evidence), and miscarriage rate per pregnancy (RR 0.90, 95% CI 0.68 to 1.20; 10 studies, 783 couples; I² = 0%, very-low quality evidence). We are uncertain if IMSI improves clinical pregnancy rates (RR 1.23, 95% CI 1.11 to 1.37; 13 studies, 2775 couples; I² = 47%, very-low quality evidence). None of the included studies reported congenital abnormalities. We judged the evidence for all outcomes to be of very low-quality. We downgraded the quality of the evidence due to limitations of the included studies (risk of bias), inconsistency of results, and a strong indication of publication bias.Authors' conclusionsThe current evidence from randomised controlled trials does not support or refute the clinical use of intracytoplasmic sperm injection (intracytoplasmic morphologically selected sperm injection (IMSI). We are very uncertain of the chances of having a live birth and of the risk of having a miscarriage. We found very low-quality evidence that IMSI may increase chances of a clinical pregnancy, which means that we are still very uncertain about any real difference. We did not find any trials reporting on the risk of congenital abnormalities. Well-designed and sufficiently powered trials are still required.

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A fast and safe technique for sperm preparation in ICSI treatments within a randomized controlled trial (RCT).

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A fast and safe technique for sperm preparation in ICSI treatments within a randomized controlled trial (RCT).

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