A Prospective Controlled Study of Karyotyping for 430 Consecutive ICSI Babies.

Objective: To study the karyotyping of ICSI babies and to compare it with the karyotyping of a control group of naturally conceived babies. Design: Prospective controlled study. The trial was designed to have adequate statistical power to detect a 2.5% difference in chromosomal anomalies, between the ICSI group and the control group. The planned sample size of 430 patients per group provided 80% power and a two-sided significant level of 0.05 to detect such difference. Materials/Methods: Karyotyping of 430 consecutive ICSI babies delivered in one hospital (group A) was performed. A control group (group B) of 430 consecutive babies from natural conception delivered in one hospital were prospectively studied for karyotyping. Results: 430 ICSI babies (group A) showed 15 abnormal karyotypes (3.5%). Of the 15 babies, 7 were of female phenotype and 8 of male phenotype. Six babies had sex chromosome anomalies, 8 babies had autosomal anomalies and one baby had a combined sex chromosome and autosomal anomalies. In the control group (group B) of 430 babies from natural conception, no abnormal karyotyping were found in all babies. The difference between the two groups is significant, p < 0.001. There was no significant difference between maternal or paternal mean age in groups A and B. Positive consanguinity was found in 31 out of 320 couples (9.7%) in group A, and in 46 couples out of 418 (11%) in group B. There was no significant difference between the two groups. In six babies with abnormal karyotyping, karyotyping for the parents was done and found to be abnormal in 2 fathers. In previous chromosomal studies done for ICSI babies, the data were compared either to the national registry data or to a retrospective matched group of IVF. This is the first study of ICSI babies in the world literature which has a control group studied prospectively. Conclusions: ICSI carries a small but significant increased risk of abnormal karyotyping to the offspring. This risk appears to be equally distributed between autosomal and sex chromosome anomalies Supported By: The Egyptian IVF-ET Center.