P-275 Physiological Intracytoplasmic Sperm Injection (PICSI) fails to improve ongoing pregnancy rates: a matched case-control study in advanced maternal age patients

IF 6 1区 医学 Q1 OBSTETRICS & GYNECOLOGY
I De Croo, S De Gheselle, F Vanden Meerschaut, L Dhaenens, C De Roo, A S Rottiers, F Vandierendonck, B Heindryckx, K Tilleman, D Stoop
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Abstract

Study question Does physiological intracytoplasmic sperm injection (PICSI) using hyaluronic acid binding prior to ICSI improve ongoing pregnancy rate in advanced maternal age patients? Summary answer No differences in ongoing pregnancy rates or miscarriage rates were observed between ICSI and PICSI cycles in patients of advanced maternal age. What is known already Sperm genomic integrity plays a crucial role in the outcomes of intracytoplasmic sperm injection (ICSI), particularly during the post-implantation stage. However, selecting spermatozoa based solely on motility and morphology does not ensure genomic integrity. Hyaluronic acid (HA), a biologically active molecule and a key component of the extracellular matrix surrounding the oocyte-cumulus complex, has been explored as a selection tool for sperm. Recent randomized controlled trials (RCT) investigating the efficacy of HA-based sperm selection prior to ICSI, have demonstrated a reduction in miscarriages after PICSI compared to conventional ICSI (Miller et al., 2019, West R. et al, 2022). Study design, size, duration A retrospective, matched case-control study was conducted between January 2020 and November 2024. A total of 288 cycles were included, 144 PICSI cycles were matched with 144 ICSI cycles. The PICSI group was matched with the ICSI group according to female age, cycle rank, number of injected oocytes and number of previous pregnancies with a 1:1 ratio. Participants/materials, setting, methods The primary outcome was ongoing pregnancy rate after the first transfer, either fresh or frozen-thawed (70 and 35 for ICSI, 66 and 38 for PICSI, respectively). Ongoing pregnancy was defined as a pregnancy showing a positive heartbeat at ultrasound after 12 weeks of gestation. The secondary outcome measures miscarriage rate (defined as pregnancy loss after confirmation of clinical pregnancy). The c2 –test was used to compare categorical variables and Student’s t-test for continuous variables. Main results and the role of chance As a result of matching, the mean female age in both groups was 37.7 ± 4.0, male age was also similar in both groups (39.6 ± 5.3 years vs. 40.2 ± 6.7 years). ). Other baseline characteristics, including cycle rank and mean gravidity showed no significant differences. Sperm parameters such as concentration (49.3 ± 50.3 million/ml in the ICSI group vs. 48.1 ± 39.0 million/ml in PICSI), and progressive motility (18.6% ± 18.2% vs. 18.6% ± 18.6%) showed also no significant differences. Fertilization rates were comparable between ICSI and PICSI group (76.0% vs. 76.1%, p = 1.000), as was the embryo utilization rate (42.0% vs. 41.9%, p = 1.000). In the total, 76 cycles resulted in no transfer due to no fertilization or impaired embryo quality (27.1% (39/144) for ICSI vs 25.7% (37/144) for PICSI, p = 0.894). The ongoing pregnancy rate following the first transfer was 19.1% for the ICSI group and 23.1% for the PICSI group (p = 0.501). The miscarriage rate was also comparable between the two groups (22.8% (8/35) vs. 21.9% (9/41), p = 1.000). The mean number of cryopreserved embryos remaining after the first transfer was similar for both groups (1.74 ± 2.14 vs 1.74 ± 2.81, p = 0994). Limitations, reasons for caution This matched case-control study has limitations due to its retrospective design and small sample size, and although factors such as age and cycle rank were matched, unaccounted confounders may still affect the outcomes. The primary outcome, ongoing pregnancy rate after the first transfer, may not reflect overall reproductive success. Wider implications of the findings The study suggests no significant difference in ongoing pregnancy rates between ICSI- and PICSI-cycles in advanced maternal age patients, questioning the routine use of hyaluronic acid for sperm selection. Trial registration number No
P-275生理胞浆内单精子注射(PICSI)不能提高妊娠率:一项匹配的病例对照研究,适用于高龄产妇
研究问题:ICSI前使用透明质酸结合的生理性胞浆内单精子注射(PICSI)是否能提高高龄产妇的持续妊娠率?高龄产妇ICSI和PICSI周期的持续妊娠率和流产率无差异。精子基因组完整性在卵胞浆内单精子注射(ICSI)的结果中起着至关重要的作用,特别是在植入后阶段。然而,仅仅根据精子的活力和形态来选择精子并不能保证基因组的完整性。透明质酸(HA)是一种生物活性分子,是围绕卵丘复合物的细胞外基质的关键成分,已被探索作为精子的选择工具。最近的随机对照试验(RCT)调查了ICSI前基于ha的精子选择的有效性,结果表明,与传统ICSI相比,PICSI后流产的发生率降低(Miller等人,2019;West R.等人,2022)。研究设计、规模、持续时间2020年1月至2024年11月进行了一项回顾性匹配病例对照研究。共纳入288个周期,144个PICSI周期与144个ICSI周期匹配。PICSI组与ICSI组根据女性年龄、周期等级、注射卵母细胞数和既往妊娠数按1:1比例配对。主要结果是首次移植后的持续妊娠率,无论是新鲜的还是冻融的(ICSI为70和35,PICSI为66和38)。持续妊娠被定义为妊娠12周后超声显示心跳阳性的妊娠。次要结局衡量流产率(定义为临床确认妊娠后的流产)。分类变量比较采用c2检验,连续变量比较采用Student’s t检验。经配对,两组患者女性平均年龄为37.7±4.0岁,男性平均年龄相近(39.6±5.3岁∶40.2±6.7岁)。. 其他基线特征,包括周期秩和平均重力没有显着差异。精子浓度(ICSI组为49.3±5030万/ml, PICSI组为48.1±3900万/ml)和进行性运动(18.6%±18.2%,PICSI组为18.6%±18.6%)也无显著差异。ICSI组与PICSI组受精率相当(76.0% vs. 76.1%, p = 1.000),胚胎利用率相当(42.0% vs. 41.9%, p = 1.000)。总共有76个周期由于没有受精或胚胎质量受损而没有移植(ICSI为27.1% (39/144),PICSI为25.7% (37/144),p = 0.894)。第一次移植后的妊娠率,ICSI组为19.1%,PICSI组为23.1% (p = 0.501)。两组的流产率也具有可比性(22.8%(8/35)比21.9% (9/41),p = 1.000)。两组首次移植后的平均冷冻胚胎数相似(1.74±2.14 vs 1.74±2.81,p = 0994)。该匹配的病例对照研究由于其回顾性设计和小样本量而存在局限性,尽管年龄和周期等级等因素匹配,但未解释的混杂因素仍可能影响结果。主要结果,第一次移植后的持续妊娠率,可能不能反映总体的生殖成功。该研究表明,高龄产妇ICSI周期和picsi周期的持续妊娠率没有显著差异,这对常规使用透明质酸进行精子选择提出了质疑。试验注册号
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来源期刊
Human reproduction
Human reproduction 医学-妇产科学
CiteScore
10.90
自引率
6.60%
发文量
1369
审稿时长
1 months
期刊介绍: Human Reproduction features full-length, peer-reviewed papers reporting original research, concise clinical case reports, as well as opinions and debates on topical issues. Papers published cover the clinical science and medical aspects of reproductive physiology, pathology and endocrinology; including andrology, gonad function, gametogenesis, fertilization, embryo development, implantation, early pregnancy, genetics, genetic diagnosis, oncology, infectious disease, surgery, contraception, infertility treatment, psychology, ethics and social issues.
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