Tjon-Kon-Fat Raïssa I, Tajik Parvin, Custers Inge M, Bossuyt Patrick M M, van der Veen Fulco, van Wely Madelon, Mol Ben W, Zafarmand Mohammad H
Centre for Reproductive Medicine, Department of Obstetrics & Gynecology, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
Centre for Reproductive Medicine, Department of Obstetrics & Gynecology, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands; Department of Epidemiology, Biostatistics & Bioinformatics, Academic Medical Center, Amsterdam, The Netherlands.
Eur J Obstet Gynecol Reprod Biol. 2016 Jul;202:36-40. doi: 10.1016/j.ejogrb.2016.04.024. Epub 2016 Apr 30.
Available treatment options in couples with unexplained or mild male subfertility are intrauterine insemination with controlled ovarian hyperstimulation (IUI-COH) and in vitro fertilisation (IVF). IUI-COH is a less invasive treatment that is often used before proceeding with IVF. Yet as the IVF success rates might be higher and time to pregnancy shorter, expedited access to IVF might be the preferred option. To identify couples that could benefit from immediate IVF over IUI-COH, we assessed whether female age, duration of subfertility or prewash total motile count (TMC) can help to identify couples that would benefit from IVF over IUI-COH.
We performed a secondary data-analysis of a multicentre open-label randomised controlled trial in three university and six teaching hospitals in the Netherlands. 116 couples with unexplained or mild male subfertility were randomised to one cycle of IVF with elective single embryo transfer with subsequent frozen-thawed embryo transfers or 3 cycles of IUI-COH. The primary outcome was an ongoing pregnancy within 4 months after randomisation. Our aim was to explore a possible differential effect of specific markers on the effectiveness of treatment. We chose to therefore assess female age, duration of subfertility and TMC as these have previously been identified as predictors. For each prognostic factor we developed a logistic regression model to predict ongoing pregnancy with that prognostic factor, treatment and a factor-by-treatment interaction term.
Female age and duration of subfertility were not associated with better ongoing pregnancy chances after IVF compared to IUI-COH (p-value for interaction=0.65 and 0.26, respectively). Only when TMC was lower than 110 (×10(6)spermatozoa/mL), the probability of ongoing pregnancy was higher in women allocated to IVF (p-value for interaction=0.06).
In couples with unexplained or mild male subfertility, a low TMC might lead to higher pregnancy rates after IVF than after IUI-COH. This finding needs to be validated in a larger trial before it can be applied in clinical practice.
对于不明原因或轻度男性不育的夫妇,现有的治疗选择包括控制性卵巢过度刺激下的宫腔内人工授精(IUI-COH)和体外受精(IVF)。IUI-COH是一种侵入性较小的治疗方法,常在进行IVF之前使用。然而,由于IVF的成功率可能更高且受孕时间更短,加快IVF的获取可能是首选方案。为了确定哪些夫妇从直接进行IVF而非IUI-COH中获益,我们评估了女性年龄、不育持续时间或洗涤前总活动精子数(TMC)是否有助于识别从IVF而非IUI-COH中获益的夫妇。
我们对荷兰三所大学和六所教学医院进行的一项多中心开放标签随机对照试验进行了二次数据分析。116对不明原因或轻度男性不育的夫妇被随机分配接受一个周期的IVF并选择性单胚胎移植,随后进行冻融胚胎移植,或3个周期的IUI-COH。主要结局是随机分组后4个月内持续妊娠。我们的目的是探讨特定标志物对治疗效果的可能差异影响。因此,我们选择评估女性年龄、不育持续时间和TMC,因为这些先前已被确定为预测因素。对于每个预后因素,我们建立了一个逻辑回归模型,以预测该预后因素、治疗以及因素与治疗的交互项对持续妊娠的影响。
与IUI-COH相比,女性年龄和不育持续时间与IVF后更好的持续妊娠机会无关(交互作用的p值分别为0.65和0.26)。仅当TMC低于110(×10⁶精子/mL)时,分配接受IVF的女性持续妊娠的概率更高(交互作用的p值为0.06)。
在不明原因或轻度男性不育的夫妇中,低TMC可能导致IVF后的妊娠率高于IUI-COH后的妊娠率。这一发现需要在更大规模的试验中得到验证,才能应用于临床实践。