Ninety babies born after round spermatid injection into oocytes: survey of their development from fertilization to 2 years of age.

OBJECTIVE: To compare physical and cognitive development of babies born after round spermatid injection (ROSI) with those born after natural conception.

DESIGN: Comparison of efficiencies of ROSI and ICSI using testicular spermatozoa, performed in the St. Mother Clinic. Physical and cognitive development of ROSI babies recorded by parents in the government-issued Mother-Child Handbook was checked and verified by attending pediatricians. Data included baby's weight gain and response to parents' voice/gesture.

SETTING: Assisted reproduction technology practice.

PATIENT(S): A total of 721 men participated in ROSI; 90 ROSI babies were followed for 2 years for their physical and cognitive development. Control subjects were 1,818 naturally born babies.

INTERVENTION(S): Surgical retrieval of spermatogenic cells from testes; selection and injection of round spermatids into oocytes; oocyte activation, in vitro culture of fertilized eggs, and embryo transfer to mothers.

MAIN OUTCOME MEASURE(S): Physical and cognitive development of ROSI babies (e.g., body weight increase, response to parents, and understanding and speaking simple language) compared with naturally born babies.

RESULT(S): Of 90 ROSI babies, three had congenital aberrations at birth, which corrected spontaneously (ventricular septa) or after surgery (cleft lip and omphalocele). Physical and cognitive development of ROSI babies was similar to those of naturally born babies.

CONCLUSION(S): There were no significant differences between ROSI and naturally conceived babies in either physical or cognitive development during the first 2 years after birth.

CLINICAL TRIAL REGISTRATION NUMBER: UMIN Clinical Trials Registry UMIN000006117.