Berntsen Sine, Zedeler Anne, Nøhr Bugge, Rønn Petersen Morten, Grøndahl Marie Louise, Andersen Lars Franch, Løssl Kristine, Løkkegaard Ellen, Englund Anne Lis, Vestergaard Gabrielsen Anette, Prætorius Lisbeth, Behrendt-Møller Ida, Langhoff Thuesen Lea, Vomstein Kilian, Petri Lauritsen Mette, Ivanoska Trajcevski Aleksandra, Frøding Skipper Dea, Westergaard David, Pinborg Anja, Svarre Nielsen Henriette, la Cour Freiesleben Nina
Department of Obstetrics and Gynaecology, The Fertility Clinic, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.
Department of Obstetrics and Gynaecology, The Fertility Clinic, Copenhagen University Hospital Herlev, Herlev, Denmark.
Nat Med. 2025 Apr 11. doi: 10.1038/s41591-025-03621-x.
Intracytoplasmic sperm injection (ICSI) and conventional in vitro fertilization (c-IVF) are widely used fertilization techniques in assisted reproduction, but their relative effectiveness in patients without severe male factor infertility remains debated. While ICSI's role in couples with severe male factor infertility is well established, its routine use in cases with normal or nonseverely decreased sperm quality is not evidence-based. Here we conducted the INVICSI study, an open-label, multicenter randomized controlled trial, to compare cumulative live birth rates (CLBR) as the primary outcome between ICSI and c-IVF in patients without severe male factor infertility. Between November 2019 and December 2022, 824 women undergoing their first IVF cycle were randomized to ICSI (n = 414) or c-IVF (n = 410) across six public fertility clinics in Denmark. The CLBR was 43.2% (179/414) in the ICSI group and 47.3% (193/408) in the c-IVF group, yielding a risk ratio of 0.91 (95% confidence interval, 0.79-1.06). These findings demonstrate that ICSI does not improve CLBR compared to c-IVF and support c-IVF as the preferred first-line treatment for patients with normal or nonseverely decreased sperm quality. ICSI should be reserved for severe male factor infertility. ClinicalTrials.gov registration: NCT04128904 .
卵胞浆内单精子注射（ICSI）和传统体外受精（c-IVF）是辅助生殖中广泛使用的受精技术，但它们在无严重男性因素不育患者中的相对有效性仍存在争议。虽然ICSI在严重男性因素不育夫妇中的作用已得到充分确立，但其在精子质量正常或轻度下降的病例中的常规使用缺乏循证依据。在此，我们开展了INVICSI研究，这是一项开放标签、多中心随机对照试验，旨在比较ICSI和c-IVF在无严重男性因素不育患者中的累积活产率（CLBR）这一主要结局。2019年11月至2022年12月期间，824名接受首次IVF周期治疗的女性在丹麦的六家公立生育诊所被随机分为ICSI组（n = 414）或c-IVF组（n = 410）。ICSI组的CLBR为43.2%（179/414），c-IVF组为47.3%（193/408），风险比为0.91（95%置信区间，0.79 - 1.06）。这些结果表明，与c-IVF相比，ICSI并不能提高CLBR，并支持将c-IVF作为精子质量正常或轻度下降患者的首选一线治疗方法。ICSI应保留用于严重男性因素不育。ClinicalTrials.gov注册号：NCT04128904 。
