Cryos International ApS – Donor-6932

Safety warnings | Blood & Tissue | 06/02/2018

The Federal Office for Safety in Health Care has been informed by the Danish authority that it has received of the Danish tissue bank Cryos International ApS (DK257551) about the disease of a child who was child conceived with semen from sperm donor 6932.es 6932 was conceived.

The report of the disease describes a child with developmental delay. Genetic comparative genomic hybridization (aCGH) revealed a 4.6Mb deletion on chromosome 3p22. on chromosome 3p22.

Both the mother and the donorr, were tested for such a deletion. The examination showed that neither the mother nor the donor are carriers of this deletion.r are carriers of this deletion. This result suggests that the deletion probably occurred probably occurred de novo in the child.

The risk assessment submitted containsincludes the following information: The donor was tested by qPCR and was found to have no was found not to have a 3p22 deletion and therefore the and consequently this alteration arose de novo in the child.

However, it cannot be excluded that the donor has a chromosomal change (balanced structural chromosomal rearrangement) that could leadwhich can lead to such a deletion in a child. child.

The risk of recurrence by the same donor is estimated to be 0.5 - 2%. estimated.

Sperm donations from this donor (incl. embryos) may still be used for parents who already have a child parents who already have a child from this donor, but only if the parents have been informed in writing. However, this is only possible if the parents have been informed in writing and accept the risk.

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