Sydney Medical School, The University of Sydney, Sydney NSW, Australia.
Australian Centre for Public and Population Health Research, Faculty of Health, University of Technology Sydney, Sydney NSW, Australia.
Hum Reprod. 2018 Jul 1;33(7):1322-1330. doi: 10.1093/humrep/dey118.
What is the cumulative live birth rate following ICSI cycles compared with IVF cycles for couples with non-male factor infertility?
ICSI resulted in a similar cumulative live birth rate compared with IVF for couples with non-male factor infertility.
The ICSI procedure was developed for couples with male factor infertility. There has been an increased use of ICSI regardless of the cause of infertility. Cycle-based statistics show that there is no difference in pregnancy rates between ICSI and IVF in couples with non-male factor infertility. However, evidence indicates that ICSI is associated with an increased risk of adverse perinatal outcomes.
STUDY DESIGN, SIZE, DURATION: A population-based cohort of 14 693 women, who had their first ever stimulated cycle with fertilization performed for at least one oocyte by either IVF or ICSI between July 2009 and June 2014 in Victoria, Australia was evaluated retrospectively. The pregnancy and birth outcomes following IVF or ICSI were recorded for the first oocyte retrieval (fresh stimulated cycle and associated thaw cycles) until 30 June 2016, or until a live birth was achieved, or until all embryos from the first oocyte retrieval had been used.
PARTICIPANTS/MATERIALS, SETTING, METHODS: Demographic, treatment characteristics and resulting outcome data were obtained from the Victorian Assisted Reproductive Treatment Authority. Data items in the VARTA dataset were collected from all fertility clinics in Victoria. Women were grouped by whether they had undergone IVF or ICSI. The primary outcome was the cumulative live birth rate, which was defined as live deliveries (at least one live birth) per woman after the first oocyte retrieval. A discrete-time survival model was used to evaluate the cumulative live birth rate following IVF and ICSI. The adjustment was made for year of treatment in which fertilization occurred, the woman's and male partner's age at first stimulated cycle, parity and the number of oocytes retrieved in the first stimulated cycle.
A total of 4993 women undergoing IVF and 8470 women undergoing ICSI had 7980 and 13 092 embryo transfers, resulting in 1848 and 3046 live deliveries, respectively. About one-fifth of the women (19.0% of the IVF group versus 17.9% of the ICSI group) had three or more cycles during the study period. For couples who achieved a live delivery, the median time from oocyte retrieval to live delivery was 8.9 months in both IVF (range: 4.2-66.5) and ICSI group (range: 4.5-71.3) (P = 0.474). Fertilization rate per oocyte retrieval was higher in the IVF than in the ICSI group (59.8 versus 56.2%, P < 0.001). The overall cumulative live birth rate was 37.0% for IVF and 36.0% for ICSI. The overall likelihood of a live birth for women undergoing ICSI was not significantly different to that for women undergoing IVF (adjusted hazard ratio (AHR): 0.99, 95% CI: 0.92-1.06). For couples with a known cause of infertility, non-male factor infertility (female factor only or unexplained infertility) was reported for 64.0% in the IVF group and 36.8% in the ICSI group (P < 0.001). Among couples with non-male factor infertility, ICSI resulted in a similar cumulative live birth rate compared with IVF (AHR: 0.96, 95% CI: 0.85-1.10).
LIMITATIONS, REASONS FOR CAUTION: Data were not available on clinic-specific protocols and processes for IVF and ICSI and the potential impact of these technique aspects on clinical outcomes. The reported causes of infertility were based on the treating clinician's classification which may vary between clinicians.
This population-based study found ICSI resulted in a lower fertilization rate per oocyte retrieved and a similar cumulative live birth rate compared to conventional IVF. These data suggest that ICSI offers no advantage over conventional IVF in terms of live birth rate for couples with non-male factor infertility.
STUDY FUNDING/COMPETING INTEREST(S): No specific funding was received to undertake this study. There is no conflict of interest, except that M.B. is a shareholder in Genea Ltd.
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对于非男性因素不孕的夫妇，与体外受精（IVF）相比，卵胞浆内单精子注射（ICSI）周期的累积活产率是多少？
对于非男性因素不孕的夫妇，ICSI 与 IVF 的累积活产率相似。
ICSI 技术是为男性因素不孕的夫妇开发的。无论不孕的原因如何，ICSI 的使用都有所增加。基于周期的统计数据显示，在非男性因素不孕的夫妇中，ICSI 和 IVF 的妊娠率没有差异。然而，有证据表明，ICSI 与围产期不良结局的风险增加有关。
研究设计、规模、持续时间：在澳大利亚维多利亚州，对 2009 年 7 月至 2014 年 6 月期间，至少有一个卵母细胞通过 IVF 或 ICSI 受精的 14693 名女性进行了回顾性队列研究。记录了 IVF 或 ICSI 后第一个卵母细胞采集（新鲜刺激周期和相关的解冻周期）的妊娠和生育结局，直到 2016 年 6 月 30 日，或直到活产，或直到第一个卵母细胞采集的所有胚胎都已使用。
参与者/材料、设置、方法：从维多利亚辅助生殖治疗管理局获得人口统计学、治疗特征和结果数据。VARTA 数据集的数据项是从维多利亚州的所有生育诊所收集的。根据是否进行 IVF 或 ICSI 将女性分组。主要结局是累积活产率，定义为第一次卵母细胞采集后至少有一次活产的女性人数。采用离散时间生存模型评估 IVF 和 ICSI 后的累积活产率。调整因素包括受精发生的治疗年份、女性和男性伴侣的首次刺激周期年龄、产次和第一个刺激周期采集的卵母细胞数量。
4993 名接受 IVF 的女性和 8470 名接受 ICSI 的女性分别进行了 7980 次和 13092 次胚胎移植，分别导致 1848 次和 3046 次活产。约五分之一的女性（IVF 组的 19.0%与 ICSI 组的 17.9%）在研究期间进行了三次或更多次周期。对于实现活产的夫妇，从卵母细胞采集到活产的中位时间在 IVF 组为 8.9 个月（范围：4.2-66.5）和 ICSI 组为 8.9 个月（范围：4.5-71.3）（P=0.474）。每个卵母细胞采集的受精率在 IVF 组中高于 ICSI 组（59.8%比 56.2%，P<0.001）。IVF 的总体累积活产率为 37.0%，ICSI 为 36.0%。ICSI 组女性活产的总体可能性与 IVF 组女性没有显著差异（调整后的危险比（AHR）：0.99，95%CI：0.92-1.06）。对于已知不孕原因的夫妇，IVF 组中 64.0%为非男性因素不孕（仅女性因素或不明原因不孕），ICSI 组中为 36.8%（P<0.001）。在非男性因素不孕的夫妇中，ICSI 与 IVF 的累积活产率相似（AHR：0.96，95%CI：0.85-1.10）。
局限性、谨慎的原因：关于 IVF 和 ICSI 的具体方案和过程的数据不可用，这些技术方面对临床结果的潜在影响。不孕的报告原因基于治疗医生的分类，这可能因医生而异。
这项基于人群的研究发现，与传统的 IVF 相比，ICSI 每卵母细胞的受精率较低，但累积活产率相似。这些数据表明，对于非男性因素不孕的夫妇，ICSI 在活产率方面与传统的 IVF 相比没有优势。
研究资助/利益冲突：没有专门的资金用于进行这项研究。除了 MB 是 Genea Ltd 的股东外，没有利益冲突。
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