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| Name | Class |
|---|---|
| Universiteit Antwerpen | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spontaneous cycle IUI | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DNA fragmentation by TUNEL assay | Diagnostic Test | Direct DNA fragmentation testing with terminal deoxyuridine nick end labeling (TUNEL) assay. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| % 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) | up to 3 months |
| % SDF in the Vital Fraction After Density Gradient in the Diagnostic Sample (Pre-IUI) |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Alessa N Sugihara, MD | University Hospital, Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Antwerpen | Edegem | Antwerp | 2650 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36675960 | Background | Sugihara A, Punjabi U, Roelant E, De Neubourg D. Is There a Relationship between Sperm DNA Fragmentation and Intra-Uterine Insemination Outcome in Couples with Unexplained or Mild Male Infertility? Results from the ID-Trial. Life (Basel). 2022 Dec 20;13(1):11. doi: 10.3390/life13010011. |
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6 included patients did not proceed to treatment; 1 due to spontaneous pregnancy - 5 loss to follow-up
Centre for Reproductive Medicine of the Antwerp University Hospital, Belgium
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| ID | Title | Description |
|---|---|---|
| FG000 | Spontaneous Cycle IUI | 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. DNA fragmentation by TUNEL assay: Direct DNA fragmentation testing with terminal deoxyuridine nick end labeling (TUNEL) assay. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Since this study relates to fertility, we have included "couples". 114 couples were included hence 114 women and 114 men.
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| ID | Title | Description |
|---|---|---|
| BG000 | Spontaneous Cycle IUI | The couples underwent natural cycle IUI with or without ovulation trigger until pregnancy was achieved for a maximum of four cycles. DNA fragmentation was measured by TUNEL assay. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 114 couples were included |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | up to 36 months |
|
|
36 months.
This was a non-interventional study. SDF testing was only carried out when the inseminating motile count was deemed sufficient, as such the treatment would not be jeopardized.
The result of the SDF test did not interfere with the allocated treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Spontaneous Cycle IUI - Sperm DNA Fragmentation Analysis | 114 couples underwent natural cycle IUI with or without ovulation trigger until pregnancy was achieved for a maximum of four cycles. Sperm DNA fragmentation testing was carried out on the diagnostic and IUI samples. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alessa Sugihara | Antwerp University Hospital, Belgium | 00328213684 | alessa.sugihara@uza.be |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 7, 2017 | Apr 19, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
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Single center, university setting, no commercial affiliation
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% of spermatozoa with DNA fragmentation in the vital fraction after density gradient in the diagnostic sample (pre-IUI) |
| 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 | 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 | 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 | 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 | 36 months |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Infertility Duration | Mean | Standard Deviation | months |
|
| Sperm concentration | This pertains to 113 men (out of the 114 included). Rarely, patients did not have a diagnostic sperm analysis at our center but elsewhere. | Median | Standard Deviation | Million spermatozoa /ml ejaculate |
|
| Sperm progressive motility | This pertains to 113 men (out of the 114 included). Rarely, patients did not have a diagnostic sperm analysis at our center but elsewhere. | Median | Standard Deviation | % progessively motile spermatozoa |
|
| Abstinence period | This pertains to 113 men (out of the 114 included). Rarely, patients did not have a diagnostic sperm analysis at our center but elsewhere. | Median | Standard Deviation | days |
|
| Semen volume | This pertains to 113 men (out of the 114 included). Rarely, patients did not have a diagnostic sperm analysis at our center but elsewhere. | Median | Standard Deviation | ml ejaculate |
|
| Total sperm count | This pertains to 113 men (out of the 114 included). Rarely, patients did not have a diagnostic sperm analysis at our center but elsewhere. | Median | Standard Deviation | Million spermatozoa |
|
| Sperm ideal morphology | This pertains to 113 men (out of the 114 included). Rarely, patients did not have a diagnostic sperm analysis at our center but elsewhere. | Median | Standard Deviation | % of total sperm count |
|
| % SDF total in ejaculate | Sperm DNA fragmentation measured by TUNEL in the total sperm population of the ejaculate | 104 men had a diagnostic sperm analysis with measurement of Sperm DNA fragmentation. | Median | Standard Deviation | % of spermatozoa with SDF in ejaculate |
|
| % SDF vital in ejaculate | Sperm DNA fragmentation measured by TUNEL in the vital sperm population of the ejaculate | 104 men had a diagnostic sperm analysis with measurement of Sperm DNA fragmentation. | Median | Standard Deviation | % of vital sperm with SDF in ejaculate |
|
| Mean menstrual cycle length | Data available of 111 out of 114 included wommen | Mean | Standard Deviation | days |
|
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| Secondary | % 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) | Posted | Median | Inter-Quartile Range | % of spermatozoa with SDF | up to 3 months |
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|
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| Secondary | % 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) | Posted | Median | Inter-Quartile Range | % of spermatozoa with SDF | up to 3 months |
|
|
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| Secondary | % 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 | number of semen samples for IUI analyzed for sperm DNA fragmentation before density gradient | Posted | Median | Inter-Quartile Range | % of spermatozoa with SDF | 36 months |
|
|
|
| Secondary | % 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 | number of semen samples for IUI analyzed for sperm DNA fragmentation before density gradient | Posted | Median | Inter-Quartile Range | % of spermatozoa with SDF | 36 months |
|
|
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| Secondary | % 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 | number of semen samples for IUI analyzed for SDF after density gradient | Posted | Median | Inter-Quartile Range | % of spermatozoa with SDF | 36 months |
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|
|
| Secondary | % 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 | number of semen samples for IUI analyzed for SDF after density gradient | Posted | Median | Inter-Quartile Range | % of spermatozoa with SDF | 36 months |
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| 228 |
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| 228 |
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| D052801 |
| Male Urogenital Diseases |