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Intracytoplasmic sperm injection versus conventional in-vitro fertilisation for couples with infertility with non-severe male factor: a multicentre, open-label, randomised controlled trial

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作者：
Wang Yuanyuan[1] ; Li Rong[1] ; Yang Rui[1] ; Zheng Danni[1] ; Zeng Lin[2] ; Lian Ying[1] ; Zhu Yimin[3] ; Zhao Junli[4] ; Liang Xiaoyan[5] ; Li Wen[6] ; Liu Jianqiao[7] ; Tang Li[8] ; Cao Yunxia[9] ; Hao Guimin[10] ; Wang Huichun[11] ; Zhang Hua[2] ; Wang Rui[12] ; Mol Ben W[12] ; Huang Hefeng[13] ; Qiao Jie[14] ;
机构： [1]National Clinical Research Centre for Obstetrical and Gynaecological Diseases, State Key Laboratory of Female Fertility Promotion, Ministry of Education Key Laboratory of Assisted Reproduction, Centre for Reproductive Medicine, Department of Obstetrics and Gynaecology, Peking University Third Hospital, Beijing, China. [2]Research Centre for Clinical Epidemiology, Peking University Third Hospital, Beijing, China. [3]Women's Hospital, Zhejiang University School of Medicine, Hangzhou, China. [4]General Hospital of Ningxia Medical University, Yinchuan, China. [5]The Sixth Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China. [6]The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China. [7]The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. [8]First Affiliated Hospital of Kunming Medical University, Kunming, China. [9]First Affiliated Hospital of Anhui Medical University, Hefei, China. [10]The Second Hospital of Hebei Medical University, Shijiazhuang, China. [11]Haidian Maternal and Child Health Hospital, Beijing, China. [12]Department of Obstetrics and Gynaecology, School of Clinical Sciences at Monash Health, Monash University, Melbourne, VIC, Australia. [13]Obstetrics and Gynaecology Hospital, Ministry of Education Key Laboratory of Reproductive Genetics, School of Medicine, Zhejiang University, Hangzhou, China. [14]National Clinical Research Centre for Obstetrical and Gynaecological Diseases, State Key Laboratory of Female Fertility Promotion, Ministry of Education Key Laboratory of Assisted Reproduction, Centre for Reproductive Medicine, Department of Obstetrics and Gynaecology, Peking University Third Hospital, Beijing, China.
出处：
DOI： 10.1016/S0140-6736(23)02416-9
ISSN：

摘要：
Introduced in 1992, intracytoplasmic sperm injection (ICSI) was initially indicated for severe male infertility; however, its use has since been expanded to non-severe male infertility. We aimed to compare the efficacy and safety of ICSI versus conventional in-vitro fertilisation (IVF) in couples with infertility with non-severe male factor.We conducted an investigator-initiated, multicentre, open-label, randomised controlled trial in ten reproductive medicine centres across China. Couples with infertility with non-severe male factor without a history of poor fertilisation were randomly assigned (1:1) to undergo either ICSI or conventional IVF. The primary outcome was live birth after first embryo transfer. We performed the primary analysis in the intention-to-treat population using log-binomial regression models for categorical outcomes or linear regression models for continuous outcomes, adjusting for centre. This trial is registered with Clinicaltrials.gov, NCT03298633, and is completed.Between April 4, 2018, and Nov 15, 2021, 3879 couples were screened, of whom 2387 (61·5%) couples were randomly assigned (1184 [49·6%] to the ICSI group and 1203 [50·4%] to the conventional IVF group). After excluding couples who were ineligible, randomised twice, or withdrew consent, 1154 (97·5%) in the ICSI group and 1175 (97·7%) in the conventional IVF group were included in the primary analysis. Live birth after first embryo transfer occurred in 390 (33·8%) couples in the ICSI group and in 430 (36·6%) couples in the conventional IVF group (adjusted risk ratio [RR] 0·92 [95% CI 0·83-1·03]; p=0·16). Two (0·2%) neonatal deaths were reported in the ICSI group and one (0·1%) in the conventional IVF group.In couples with infertility with non-severe male factor, ICSI did not improve live birth rate compared with conventional IVF. Given that ICSI is an invasive procedure associated with additional costs and potential increased risks to offspring health, routine use is not recommended in this population.National Natural Science Foundation of China, National Key Research and Development Program, Beijing Municipal Science & Technology Commission, and Peking University Third Hospital.Copyright © 2024 Elsevier Ltd. All rights reserved.

基金：
National Natural Science Foundation of China (82288102), the National Key Research and Development Program (2022YFC2702500), the Beijing Municipal Science & Technology Commission (Z191100006619085), and the Peking University Third Hospital (BYSYZD2019007, BYSYDL2022001).
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外文
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大类 | 1 区 医学
小类 | 1 区 医学：内科
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出版当年[2024]版：
无
最新[2023]版：
Q1 MEDICINE, GENERAL & INTERNAL

影响因子： 最新[2023版] 最新五年平均 出版当年[2024版] 出版当年五年平均 出版前一年[2023版]

第一作者：
第一作者机构： [1]National Clinical Research Centre for Obstetrical and Gynaecological Diseases, State Key Laboratory of Female Fertility Promotion, Ministry of Education Key Laboratory of Assisted Reproduction, Centre for Reproductive Medicine, Department of Obstetrics and Gynaecology, Peking University Third Hospital, Beijing, China.
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通讯作者：
推荐引用方式(GB/T 7714)：
Wang Yuanyuan,Li Rong,Yang Rui,et al.Intracytoplasmic sperm injection versus conventional in-vitro fertilisation for couples with infertility with non-severe male factor: a multicentre, open-label, randomised controlled trial[J].LANCET.2024,403(10430):924-934.doi:10.1016/S0140-6736(23)02416-9.
APA：
Wang Yuanyuan,Li Rong,Yang Rui,Zheng Danni,Zeng Lin...&Qiao Jie.(2024).Intracytoplasmic sperm injection versus conventional in-vitro fertilisation for couples with infertility with non-severe male factor: a multicentre, open-label, randomised controlled trial.LANCET,403,(10430)
MLA：
Wang Yuanyuan,et al."Intracytoplasmic sperm injection versus conventional in-vitro fertilisation for couples with infertility with non-severe male factor: a multicentre, open-label, randomised controlled trial".LANCET 403..10430(2024):924-934

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