An interventional study of DNA fragmentation by TUNEL assay in Infertility Unexplained, Infertility, Male and DNA Damage, sponsored by University Hospital, Antwerp. Completed at 1 site in Belgium. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-15.
Sponsored by University Hospital, Antwerp · Not applicable, Interventional, and Diagnostic
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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.
282 studies on the registry are indexed under Infertility, Male; 65 are open to participants now.
This study's enrollment of 120 is above the median of 80 across 187 interventional studies indexed under Infertility, Male.
Browse Infertility, Male studies →University Hospital, Antwerp is the lead sponsor of 243 studies on the registry; 66 are open to participants now.
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Couples seeking fertility treatment after at least 12 months of unprotected intercourse are eligible. All couples underwent basic fertility investigations which included semen analysis, evaluation of menstrual cycle, and tubal patency testing.
Exclusion Criteria:
Double sided tubal disease, severe endometriosis (classified as revised American Society for Reproductive Medicine stage III or IV), premature ovarian failure, and known endocrine disorders (such as Cushing's syndrome or adrenal hyperplasia), azoö- or necrozoospermia
DNA fragmentation by TUNEL assay DNA fragmentation will be measured both at the time of the diagnostic work-up as at the time of insemination.
Diagnostic Test: DNA fragmentation by TUNEL assay
Direct DNA fragmentation testing with terminal deoxyuridine nick end labeling (TUNEL) assay.
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
Centre for Reproductive Medicine of the Antwerp University Hospital, Belgium
| Milestone | Spontaneous Cycle IUI |
|---|---|
| Started | 114 |
| Completed | 114 |
| Not completed | 0 |
The odds ratio on live birth per unit increase in % total Sperm DNA Fragmentation of the diagnostic sample.
| Participants | Spontaneous Cycle IUI - Sperm DNA Fragmentation Analysis |
|---|---|
| DNA Fragmentation as a Predictor of Live Birth Rate | 32 |
% of spermatozoa with DNA fragmentation in the total fraction after density gradient in the diagnostic sample (pre-IUI)
| % of spermatozoa with SDF | Spontaneous Cycle IUI |
|---|---|
| % SDF in the Total Fraction After Density Gradient in the Diagnostic Sample (Pre-IUI) | 9.6 (4.6 to 20.1) |
% of spermatozoa with DNA fragmentation in the vital fraction after density gradient in the diagnostic sample (pre-IUI)
| % of spermatozoa with SDF | Spontaneous Cycle IUI |
|---|---|
| % SDF in the Vital Fraction After Density Gradient in the Diagnostic Sample (Pre-IUI) | 0.6 (0.2 to 1) |
% of spermatozoa with DNA fragmentation in the total fraction in the ejaculate (before density gradient) of the IUI-sample
| % of spermatozoa with SDF | Spontaneous Cycle IUI |
|---|---|
| % SDF in the Total Fraction in the Ejaculate of the IUI- Sample | 8 (5 to 12) |
% of spermatozoa with DNA fragmentation in the vital fraction in the ejaculate (before density gradient) of the IUI-sample
| % of spermatozoa with SDF | Spontaneous Cycle IUI |
|---|---|
| % SDF in the Vital Fraction in the Ejaculate of the IUI- Sample | 1 (0 to 2) |
% of spermatozoa with DNA fragmentation in the total fraction after density gradient in the IUI sample
| % of spermatozoa with SDF | Spontaneous Cycle IUI |
|---|---|
| % SDF in the Total Fraction After Density Gradient in the IUI Sample | 8.3 (4 to 14) |
% of spermatozoa with DNA fragmentation in the vital fraction after density gradient in the IUI sample
| % of spermatozoa with SDF | Spontaneous Cycle IUI |
|---|---|
| % SDF in the Vital Fraction After Density Gradient in the IUI Sample | 0.4 (0.2 to 1) |
Collected over 36 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Spontaneous Cycle IUI - Sperm DNA Fragmentation Analysis | 0/228 (0%) | 0/228 (0%) | 0/228 (0%) |
Since this study relates to fertility, we have included "couples". 114 couples were included hence 114 women and 114 men.
| Age, Continuous(years) | Spontaneous Cycle IUI |
|---|---|
| Women | 30.3 ± 3.7 |
| Men | 32.8 ± 5.3 |
| Sex: Female, Male(Participants) | Spontaneous Cycle IUI |
|---|---|
| Female | 114 |
| Male | 114 |
| Race and Ethnicity Not Collected(Participants) | Spontaneous Cycle IUI |
|---|
| Infertility Duration(months) | Spontaneous Cycle IUI |
|---|---|
| Mean | 23.3 ± 12.4 |
| Sperm concentration(Million spermatozoa /ml ejaculate) | Spontaneous Cycle IUI |
|---|---|
| Median | 48 ± 63.7 |
| Sperm progressive motility(% progessively motile spermatozoa) | Spontaneous Cycle IUI |
|---|---|
| Median | 55 ± 16 |
| Abstinence period(days) | Spontaneous Cycle IUI |
|---|---|
| Median | 4 ± 2 |
| Semen volume(ml ejaculate) | Spontaneous Cycle IUI |
|---|---|
| Median | 3.7 ± 2.3 |
5 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Oct 2017 to primary completion in May 2021, 43 months.
Results were first posted in Nov 2024, 3 years 5 months after primary completion.
Of 77 non-industry interventional studies with no phase under Infertility, Male, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 50. This study's 43 months is above that.
Counting every sponsor, half of 92 studies reached it within 34 months; a quarter within 17 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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