Agarwal Pratibha, Loh Sheila Kia Ee, Lim Sok Bee, Sriram Bhavani, Daniel Mary Lourdes, Yeo Seow Heong, Heng Derrick
Department of Neonatology, KK Women's and Children's Hospital, Singapore.
BJOG. 2005 Oct;112(10):1376-83. doi: 10.1111/j.1471-0528.2005.00663.x.
Primary outcome was to compare neurodevelopmental outcome at two years in intracytoplasmic sperm injection (ICSI) conceived children versus matched controls. Secondary outcome was to determine incidence of major congenital malformations and study perinatal outcome.
Prospective cohort study.
Tertiary care perinatal centre over a period of 13 months.
Seventy-six ICSI conceived children and 261 matched controls selected by matching for maternal age, sex, date of delivery, race, plurality and parity.
Mental Development Index (MDI) and Psychometric Development Index (PDI) of the Bayley's Scale of Development (BSID-II) and Vineland Adaptive Behaviour Scale (VABS) were used to assess the neurodevelopmental and functional outcome. The congenital malformations were classified according to ICD-9 code.
Primary outcome measure--neurodevelopmental and functional outcomes. Secondary outcome measure--congenital malformations and perinatal outcomes.
Neurodevelopmental and functional outcome were comparable in both groups. The mean MDI score was 92 [16] versus 90 [14] in the study and control groups respectively. Fourteen (18.4%) in the ICSI group had MDI <85 compared with 87 (33%) controls (P= 0.002). On linear regression the MDI was independently affected by plurality (P= 0.001), maternal education and socio-economic status (P= 0.01). The study group had a lower gestation (36 [3] vs 37.1 [2] weeks; P= 0.005) and a higher incidence of prematurity <34 weeks [19 (25%)] vs [31 (12%)] P= 0.012]. Six (7.9%) of the ICSI babies and seven (2.7%) of the controls had a major congenital malformation (P= 0.05).
Children born by ICSI pregnancies did not have an adverse neurodevelopmental outcome. The incidence of major congenital malformations in ICSI needs further evaluation.
主要结局是比较经胞浆内单精子注射（ICSI）受孕儿童与匹配对照组在两岁时的神经发育结局。次要结局是确定主要先天性畸形的发生率并研究围产期结局。
前瞻性队列研究。
三级护理围产期中心，为期13个月。
76例经ICSI受孕的儿童和261例匹配对照组，根据母亲年龄、性别、分娩日期、种族、胎次和产次进行匹配。
使用贝利发育量表（BSID-II）的心理发育指数（MDI）和心理测量发育指数（PDI）以及文兰适应行为量表（VABS）评估神经发育和功能结局。先天性畸形根据ICD-9编码进行分类。
主要结局指标——神经发育和功能结局。次要结局指标——先天性畸形和围产期结局。
两组的神经发育和功能结局具有可比性。研究组和对照组的平均MDI评分分别为92[16]和90[14]。ICSI组中有14例（18.4%）MDI<85，而对照组有87例（33%）（P=0.002）。在线性回归分析中，MDI独立受胎次（P=0.001）、母亲教育程度和社会经济地位（P=0.01）影响。研究组的孕周较短（36[3]周对37.1[2]周；P=0.005），<34周早产的发生率较高[19例（25%）对31例（12%），P=0.012]。6例（7.9%）ICSI婴儿和7例（2.7%）对照组婴儿有主要先天性畸形（P=0.05）。
ICSI受孕出生的儿童没有不良神经发育结局。ICSI中主要先天性畸形的发生率需要进一步评估。
