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首页> 美国卫生研究院文献>British Medical Journal >Prevention of multiple pregnancies in couples with unexplained or mild male subfertility: randomised controlled trial of in vitro fertilisation with single embryo transfer or in vitro fertilisation in modified natural cycle compared with intrauterine insemination with controlled ovarian hyperstimulation
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Prevention of multiple pregnancies in couples with unexplained or mild male subfertility: randomised controlled trial of in vitro fertilisation with single embryo transfer or in vitro fertilisation in modified natural cycle compared with intrauterine insemination with controlled ovarian hyperstimulation

机译：预防原因不明或轻度男性不育的夫妇多胎妊娠：随机对照试验：单胚胎移植体外受精或改良自然周期体外受精与宫内授精与卵巢过度刺激相比较

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>Objectives To compare the effectiveness of in vitro fertilisation with single embryo transfer or in vitro fertilisation in a modified natural cycle with that of intrauterine insemination with controlled ovarian hyperstimulation in terms of a healthy child.>Design Multicentre, open label, three arm, parallel group, randomised controlled non-inferiority trial.>Setting 17 centres in the Netherlands.>Participants Couples seeking fertility treatment after at least 12 months of unprotected intercourse, with the female partner aged between 18 and 38 years, an unfavourable prognosis for natural conception, and a diagnosis of unexplained or mild male subfertility.>Interventions Three cycles of in vitro fertilisation with single embryo transfer (plus subsequent cryocycles), six cycles of in vitro fertilisation in a modified natural cycle, or six cycles of intrauterine insemination with ovarian hyperstimulation within 12 months after randomisation.>Main outcome measures The primary outcome was birth of a healthy child resulting from a singleton pregnancy conceived within 12 months after randomisation. Secondary outcomes were live birth, clinical pregnancy, ongoing pregnancy, multiple pregnancy, time to pregnancy, complications of pregnancy, and neonatal morbidity and mortality>Results 602 couples were randomly assigned between January 2009 and February 2012; 201 were allocated to in vitro fertilisation with single embryo transfer, 194 to in vitro fertilisation in a modified natural cycle, and 207 to intrauterine insemination with controlled ovarian hyperstimulation. Birth of a healthy child occurred in 104 (52%) couples in the in vitro fertilisation with single embryo transfer group, 83 (43%) in the in vitro fertilisation in a modified natural cycle group, and 97 (47%) in the intrauterine insemination with controlled ovarian hyperstimulation group. This corresponds to a risk, relative to intrauterine insemination with ovarian hyperstimulation, of 1.10 (95% confidence interval 0.91 to 1.34) for in vitro fertilisation with single embryo transfer and 0.91 (0.73 to 1.14) for in vitro fertilisation in a modified natural cycle. These 95% confidence intervals do not extend below the predefined threshold of 0.69 for inferiority. Multiple pregnancy rates per ongoing pregnancy were 6% (7/121) after in vitro fertilisation with single embryo transfer, 5% (5/102) after in vitro fertilisation in a modified natural cycle, and 7% (8/119) after intrauterine insemination with ovarian hyperstimulation (one sided P=0.52 for in vitro fertilisation with single embryo transfer compared with intrauterine insemination with ovarian hyperstimulation; one sided P=0.33 for in vitro fertilisation in a modified natural cycle compared with intrauterine insemination with controlled ovarian hyperstimulation).>Conclusions In vitro fertilisation with single embryo transfer and in vitro fertilisation in a modified natural cycle were non-inferior to intrauterine insemination with controlled ovarian hyperstimulation in terms of the birth of a healthy child and showed comparable, low multiple pregnancy rates.>Trial registration Current Controlled Trials ISRCTN52843371; Nederlands Trial Register NTR939.
机译：>目的比较健康孩子对体外受精，单胚胎移植或体外受精的自然周期与宫内授精与控制性卵巢过度刺激的效果。>设计< / strong>多中心，开放标签，三臂平行组，随机对照非劣效性试验。>在荷兰设置17个中心。>参与者至少在寻求生育治疗的夫妇12个月无保护的性交，女性伴侣年龄在18至38岁之间，自然受孕预后不良，并且诊断出原因不明或轻度的男性不育。>干预三个周期的单次体外受精胚胎移植（加上随后的冷冻周期），修改后的自然周期中的六个体外受精周期或六个卵巢内过度刺激的宫内授精周期n随机分配后12个月。>主要结局指标：主要结局是在随机分配后12个月内因单胎妊娠而出生的健康孩子。次要结局为活产，临床妊娠，持续妊娠，多胎妊娠，怀孕时间，妊娠并发症以及新生儿发病率和死亡率。>结果 2009年1月至2012年2月之间随机分配了602对夫妇。 201只被分配给具有单个胚胎移植的体外受精，194只被分配给经过修改的自然周期的体外受精，而207只被分配给具有受控卵巢过度刺激的子宫内授精。在单胎移植组的体外受精中，有104对夫妇生育了健康的孩子（52％），在改良自然周期组的体外受精中有83对（43％），宫腔内有97对（47％）卵巢受精控制组受精。相对于子宫内授精与卵巢过度刺激的风险，单次胚胎移植体外受精的风险为1.10（95％置信区间0.91至1.34），而在改良的自然周期中进行体外受精的风险为0.91（0.73至1.14）。这些95％的置信区间不会低于自卑的预定义阈值0.69。进行单胚胎移植的体外受精后，每次正在进行的妊娠的多重妊娠率分别为6％（7/121），经过修改的自然周期的体外受精后为5％（5/102），宫内术后为7％（8/119）卵巢过度刺激的人工授精（单卵移植体外受精的单侧P = 0.52与卵巢过度刺激的宫内人工授精的单侧P = 0.33;与受控的卵巢过度刺激的宫腔人工授精相比，改良自然周期的体外受精的单侧P = 0.33）。 >结论就健康孩子的出生而言，单胚胎移植的体外受精和改良自然周期的体外受精均不亚于可控制的卵巢过度刺激的宫腔内人工授精，且倍数低>试验注册当前的对照试验ISRCTN52843371； Nederlands试用注册簿NTR939。

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