Infertility affects about 10% of all couples and is defined by a failure to achieve a clinical pregnancy within a year of regular unprotected sexual intercourse. Up to one third of these couples will not have an identifiable cause after routine investigation, id est idiopathic infertility. The current diagnosis of male infertility relies on the World Health Organization (WHO) 2010 criteria which focus on concentration, motility and morphology in comparison to cut-off values of a fertile population. Alas, the relevance of the conventional semen analysis for the choice of treatment and the predictive value for an infertile couple with idiopathic or mild male infertility embarking on medically assisted reproduction (MAR) remains questionable. In other words, there is a strong clinical need to distinguish fertile from infertile men through new sperm function testing and to be able to select both the patient population who will benefit from MAR as well as the type of treatment. Numerous studies utilizing different techniques for assessing sperm DNA fragmentation support the existence of a significant association between sperm DNA damage and pregnancy outcomes. In this prospective cohort study the investigators aim to study the role of sperm DNA fragmentation analysis in selecting the patient who will benefit from intra-uterine insemination (IUI) therapy since IUI is still considered the first step in MAR and is performed at a large scale in Belgium and worldwide.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
120
Direct DNA fragmentation testing with terminal deoxyuridine nick end labeling (TUNEL) assay.
Universitair Ziekenhuis Antwerpen
Edegem, Antwerp, Belgium
DNA Fragmentation as a Predictor of Live Birth Rate
The odds ratio on live birth per unit increase in % total Sperm DNA Fragmentation of the diagnostic sample.
Time frame: up to 36 months
% SDF in the Total Fraction After Density Gradient in the Diagnostic Sample (Pre-IUI)
% of spermatozoa with DNA fragmentation in the total fraction after density gradient in the diagnostic sample (pre-IUI)
Time frame: up to 3 months
% SDF in the Vital Fraction After Density Gradient in the Diagnostic Sample (Pre-IUI)
% of spermatozoa with DNA fragmentation in the vital fraction after density gradient in the diagnostic sample (pre-IUI)
Time frame: up to 3 months
% SDF in the Total Fraction in the Ejaculate of the IUI- Sample
% of spermatozoa with DNA fragmentation in the total fraction in the ejaculate (before density gradient) of the IUI-sample
Time frame: 36 months
% SDF in the Vital Fraction in the Ejaculate of the IUI- Sample
% of spermatozoa with DNA fragmentation in the vital fraction in the ejaculate (before density gradient) of the IUI-sample
Time frame: 36 months
% SDF in the Total Fraction After Density Gradient in the IUI Sample
% of spermatozoa with DNA fragmentation in the total fraction after density gradient in the IUI sample
Time frame: 36 months
% SDF in the Vital Fraction After Density Gradient in the IUI Sample
% of spermatozoa with DNA fragmentation in the vital fraction after density gradient in the IUI sample
Time frame: 36 months
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