Tableau des Rapid Alerts

Le tableau ci-dessous reprend la liste des 30 « Rapid Alerts » européennes où la limite légale belge de 6 femmes, ayant eu au moins un enfant par donneur, a été dépassée (à partir de 2022). Nombre de femmes ayant eu au moins un enfant (traitement en Belgique). 

Les données présentées dans ce tableau dépendent des informations communiquées par les centres de fertilité. Ces données sont susceptibles d'évoluer. L’agence ne peut garantir leur exhaustivité ni leur exactitude. Le nombre de grossesses repris dans ce tableau ne correspond pas nécessairement à des grossesses avérées ni à des naissances. Il peut exister une différence entre le nombre de grossesses, le nombre d’enfants et les données disponibles au moment de la déclaration (p. ex. grossesses interrompues, grossesses encore en cours, nouvelles grossesses).
Il est important de noter que le blocage d’un donneur n’empêche pas l’utilisation de ses gamètes pour un projet parental concernant des frères et sœurs déjà nés de don de ce donneur. Ainsi, même si le nombre de familles n’augmentera plus, le nombre d’enfants au sein d’une même famille peut encore évoluer.

Une Rapid Alert est une notification émise par une autorité compétente d’un Etat membre de l’Union européenne afin d’informer les autres Etats membres impliqués en cas de risque sanitaire lié à l'utilisation de tissus et cellules. Lorsqu’un donneur de sperme fait l’objet d’une Rapid Alert, il est bloqué de manière permanente et son sperme ne peut plus être utilisé pour le traitement d'une nouvelle femme. 

 Donneur X

Banque de sperme du donneur

Autres pays utilisateurs du donneur

Nombre de femmes ayant eu au moins un enfant en Belgique

Nombre d'enfants 

Nombre de centres belges de fertilité qui ont reçu le sperme du donneur

Année d'émission de la Rapid Alert

Risque confirmé à l'utilisation du sperme du donneur

Donor 1

ESB

AT, DE, FI, FR, IE, IS, MT, NL, NO, PT, SE, XI

7

9

6

2022

First blockage:

Donor is a carrier of classic galactosemia. His gametes are permanently blocked 23MAY2022.

 

Second blockage:

The donor is carrier of Shwachman-Diamond syndrome. His gametes were already permanently blocked in May 2022 due to his carrier status of classic galactosemia.

Donor 2

ESB

BG, ES, GR, HU, IT, LV, PL

20

20

13

2022

A pathogenic variant in the PHA gene has been identified in donor and he is a carrier of PKU why his gametes are permanently blocked 11JUL2022.

Donor 3

ESB

AT, CY, DE, FI, HU, IE, IS, MT, NL,

NO, PT, SE, XI

10

10

5

2022

Donor is a carrier of autosomal recessive inherited mild-to-moderate sensorineural hearing loss due to a STRC deletion and according to the current interpretation of the Danish legislation his gametes are permanently blocked 02SEP2022.

Donor 4

ESB

AT CY DE FI IE IS NL NO PT SE XI

14

14

4

2022

The donor is a carrier of congenital disorder of glycosylation type Ia. His gametes are permanently blocked 15DEC2022.

Donor 5

ESB

HU PL

17

22

13

2023

Hip dysplasia in a donor confers an increased risk to his offspring. His gametes are permanently blocked 18JAN2023.

Donor 6

ESB

GR IE PL

9

11

8

2023

Donor is a carrier of c.10955delC(p.Pro3652Glnfs*2) in the PKHD1 gene. His gametes are to be permanently blocked 20MAR2023.

Donor 7

ESB

PL

11

11

9

2023

A deletion of exon 11-14 in the GLI2 gene in a donor child does confer an increased risk to donor’s offspring. His gametes are permanently blocked 24MAR2023.

Donor 8

ESB

ES GR HU

8

10

8

2023

Donor is compound heterozygous for hemochromatosis. His gametes are therefore permanently blocked 15JUN2023.

Donor 9

ESB

ES GR IE IS IT LV PL

8

8

7

2023

A duplication of 22q11 in the donor might confer an increased risk to his offspring. His gametes are permanently blocked 04JUL2023.

Donor 10

ESB

AT DE FI FR GB IE IS NL NO PT SE

12

16

5

2023

The genetic examination of the donor shows that he has a deletion in exon 16-29 of the STRC gene. Hearing impairment in a donor child may confer an increased risk to donor’s offspring. Donor’s gametes are blocked 05JUL2023.

Donor 11

ESB

AT CY DE EE FI FR GB IE IS NL NO

PT SE

10

11

4

2023

Donor investigation shows donor to be a carrier of 57kb deletion in the CTNS-gene. A 57 kb deletion in CTNS-gene in a donor child does confer an increased risk to donor’s offspring. Donor’s gametes are to be permanently blocked 08AUG2023.

Donor 12

ESB

BG CY DE ES GR HU IE IS NL PL

38

53

14

2023

TP53 variant in a donor does confer an increased risk to donor’s offspring. His gametes are permanently blocked 30OCT2023.

Donor 13

ESB

ES IT LV

12

15

8

2023

The donor has been under investigation and the results have shown that he is a carrier of neonatal Zellweger syndrome, since he is heterozygous for the mutation in the PEX6

gene. Zellweger syndrome in a donor child does confer an increased risk to donor’s offspring. His gametes are permanently blocked 07DEC2023.

Donor 14

ESB

AT DE FI IE IS LU MT NL NO PT SE XI

11

12

6

2023

Genetic testing showed that Donor is carrier of one of the two RAG2 variants. RAG2 deficiency results in the severe phenotype Severe combined immune deficiency SCID. Due to the fact that donor is known carrier of a recessive gene variant he is permanently blocked 08NOV2023.

Donor 15

ESB

AT DE GB IS NL NO PT SE

7

8

4

2024

Isovaleric acidemia in a donor child, and subsequent genetic analysis showing that donor is heterozygous carrier of a pathogenic variant in the IVD gene; c.158G>A,

p.Arg53His, does confer an increased risk to donor’s offspring. His gametes are therefore permanently blocked 20DEC2023.

Donor 16

ESB

HU

10

10

10

2024

The donors Family history reveals that the PD has an unspecified hernia, his identical twin brother was born with coarctation of his aorta and his paternal aunt was born with

only one kidney. Hydronephrosis in a donor child does confer an increased risk to donor’s offspring. His gametes are therefore permanently blocked 31Jan2024.

Donor 17

ESB

BG EE ES GR HU IE IT LV PL

18

23

9

2024

MSH2 variant in a donor does confer an increased risk to donor’s offspring. His gametes are to be permanently blocked.

Donor 18

ESB

ES GR

14

16

8

2024

The pathogenic variant ing the GAA gene was identified in the donor. Biallellic pathogenic variants in the GAA gene cause Pompes disease. A pathogenic variant in the GAA

gene does confer an increased risk to a donor child. His gametes are to be permanently blocked.

Donor 19

ESB

ES IT MT PL

8

12

9

2024

Pathogenic MYBPC3 variant in a fetus and found in the donor confers an increased risk to donor’s offspring. His gametes are permanently blocked 07NOV2024.

Donor 20

ESB

BG CY ES GR HU IS IT LV PL RO

21

24

10

2024

Cardiomyopathy in a donor child and subsequent diagnosis of heterozygosity of a pathogenic variant in APLK3 gene in the donor confers an increased risk to donor’s offspring.

The donor is blocked and his gametes can no longer be used. The case is closed and reported to the Danish Patient Safety Authorities. 19NOV2024.

Donor 21

ESB

BG EE FR GR HU IS LT LV PL RO

17

20

10

2025

Investigation of donor shows a 109kb deletion involving the NRXN1 gene. Donor will be permanently blocked 21JAN2025.

Donor 22

Cryos

AT BG CY DE ES FR GB GR HU

IE IT LU LV NL PL RO SE

11

12

4*

2025

Donor has been tested and carries a variant in USH2A. The risk of an affected child is lower than 1%. Donor gametes were blocked for new customers (<1% recurrence risk) 02NOV2022 but can be used for siblings. Reported to the Danish Patient Safety Authority 25FEB2025.

Donor 23

ESB

BG CY EE ES GR HU IT LV PL

27

34

14

2025

The donor has been investigated and has an extraordinary genetic constellation since he has 3 copies of the FBN1 gene: 2 normal FBN1 genes and a copy of FBN1 with deletion

of exon 1-4. Donor gametes are blocked 30APR 2025. We recommend that donor conceived children of donor are referred for paediatric evaluation to assess the relevance of genetic counselling and examination.

Donor 24

ESB

AT CY DE FR GB GR IE IS NL PT

SE

10

10

5

2025

We can conclude that the donor has a genotype with a deletion of SMN1 on one chromosome and two copies of SMN1 on the other chromosome. The donor will be

permanently blocked 20JAN2025.

Donor 25

ESB

BG CY CZ EE ES GR HU IE IS IT LT LU PL RO

19

27

12

2025/2026

First blockade : The donor is found to be a healthy carrier of a pathogenic variant in the CYP21A2 gene. Non-Classical congenital adrenal hyperplasia (CAH) due to compound heterozygous mutations in the CYP21A2 gene in a donor child confers an increased risk to donor's offspring. His gametes are permanently blocked. The case is reported to the Danish Patient Safety Authorities. 07JUL2025.

Second blockade : Gametes of the donor were previously pemanently blocked because he is a carrier of a pathogenic variant in the CYP21A2 gene. A new permanent block notification will be issued because the donor is a carrier of a pathogenic variant in the NPC1 gene. 

Donor 26

ESB

FR GR HU IS LV PL

9

9

8

2025

Deletion of the CYP21A2 gene in a donor does confer an increased risk to donor’s offspring. His gametes are to be permanently blocked. The case is closed and reported to the

Danish Patient Safety Authorities. 19AUG2025.

Donor 27

ESB

ES IT NL PL

12

15

10*

2025

A pathogenic (class V) genetic variant was observed in the Thyroglobulin (TG) gene. Congenital hypothyroidism in a donor child does confer an increased risk to donor’s

offspring. His gametes are to be permanently blocked. The case is closed and is to be reported to the Danish Patient Safety Authorities. 13OCT2025.

Donor 28

ESB

BG CY DE ES FR GR HU IE IS IT LT LU LV PL RO SE XI

22

29

10

2025

The donor is a carrier of Metachromatic leukodystrophy (MLD), since a pathogenic genetic variant in the Arylsulfatase A (ARSA) gene is identified in a heterozygous state. A pathogenic genetic variant :NM_000487.6:c.917C>T, identified in the donor does confer an increased reproductive risk. His gametes are to be permanently blocked.

20OCT2025.

Donor 29

ESB

BG CY EE ES FR GR HU IE IS IT LV PL 

14 

22

10

2025

The donor has been under investigation and the results have shown that he is a healthy carrier of Spinal Muscular Atrophy, since MLPA analysis shows a deletion of one of the SMN1 genes. 

Donor 30

ESB

BG CY EE FR GR HU IS LV PL RO

10

11

10

2025

The CHEK2 variant c1100delC found in the donor confers an increased risk to donor's offspring. The donor will be permanently blocked and the case reported to Danish health authorities. 27NOV2025

* private recipient(s)

 

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