This study is performed at Malmø University Hospital at the Department of Growth and Reproduction in collaboration with several Danish fertility clinics.

The gold standard in assessment of male reproductive function is standard semen analysis including evaluation of sperm number, motility and morphology. Although efforts have been made to improve and standardise the methodology for semen analysis, there are no well-established cut off levels for sperm concentration, motility or morphology which accurately predict the chance of pregnancy nor indicate which assisted reproductive technique (ART) will be the most effective (IVF or ICSI).

Attention has been paid to impairment of sperm DNA integrity as a possible cause of male subfertility. Sperm with fragmented DNA structure is increased among sub-fertile men compared to fertile men from the general population.

Sperm Chromatin Structure Assay (SCSA) is an assay that measures the DNA Fragmentation Index (DFII) in sperm. The chance of in vivo pregnancy is decreases with DFI levels above 20% and virtually 0 %, if DFI exceeds 30%. It seems, however, that even spermatozoa from samples with high DFI can be used for in vitro fertilisation by standard IVF or Intra Cytoplasmic Sperm Injection (ICSI). Some data even indicate that ICSI might actually be more efficient using samples with spermatozoa with DFI > 30%. It has, however, been postulated that children conceived by IVF/ICSI have somewhat increased risk of congenital abnormalities, but no conclusive findings have been obtained.

This study will analyse DFI for 8.000 men, who attend help for IVF/ICSI treatment. For the whole cohort, the outcome of IVF/ICSI treatments with use of ejaculates with DFI<30% will be compared with sperm with DFI>30%. The outcome data will be fertilisation rates, embryo quality and miscarriage rate.

These treatments are expected to result in 2 000 live births. A cohort of these children will be followed through the National Birth Register and other Swedish and Danish registries to assess the impact of high level sperm DNA damage in relation to perinatal characteristics and health of IVF/ICSI children.

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