Infertility UnexplainedNCT03319654
Impact of DNA Fragmentation in Sperm on Pregnancy Outcome After Intra-uterine Insemination in a Spontaneous Cycle
A study testing DNA fragmentation by TUNEL assay in people with Infertility Unexplained and Infertility, Male, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Infertility Unexplained, Infertility, Male, DNA Damage
- What is being tested?
- DNA fragmentation by TUNEL assay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Oct 2017to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Infertility Unexplained, Infertility, Male, DNA Damage
- Being tested
- DNA fragmentation by TUNEL assay
- Keywords
- Unexplained Infertility, Idiopathic Infertility, DNA damage, DNA fragmentation, Insemination
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA fragmentation by TUNEL assayDiagnostic test
Direct DNA fragmentation testing with terminal deoxyuridine nick end labeling (TUNEL) assay.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: DNA fragmentation by TUNEL assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 36 months
Secondary outcomes (6)
% 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start5 Oct 2017
- Primary completion31 May 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infertility UnexplainedStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single center, university setting, no commercial affiliation
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen
- Responsible party
- Principal investigator, Alessa Sugihara, University Hospital, Antwerp
- Investigators
- Alessa N Sugihara, MD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319654
- Sponsor's protocol ID
- UZA TBM -DNA IUI 2017
- Status last verified
- Sep 2024
- First submitted
- 15 Sep 2017
- Last updated
- 15 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36675960
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of DNA Fragmentation in Sperm on Pregnancy Outcome After Intra-uterine Insemination in a Spontaneous Cycle
- ClinicalTrials.gov ID
- NCT03319654
- Acronym / sponsor ID
- UZA TBM -DNA IUI 2017
- Conditions
- Infertility Unexplained, Infertility, Male, DNA Damage
- Keywords
- Unexplained Infertility, Idiopathic Infertility, DNA damage, DNA fragmentation, Insemination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen
- Study start
- 5 Oct 2017 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 24 Oct 2017 (actual)
- Results
- Posted 15 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single center, university setting, no commercial affiliation
| Arm | Type | Receives |
|---|---|---|
| Spontaneous cycle IUI | Experimental | Diagnostic Test: DNA fragmentation by TUNEL assayDNA fragmentation by TUNEL assay DNA fragmentation will be measured both at the time of the diagnostic work-up as at the time of insemination. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA fragmentation by TUNEL assayDirect DNA fragmentation testing with terminal deoxyuridine nick end labeling (TUNEL) assay. | Diagnostic test | Spontaneous cycle IUI |
Primary outcome
DNA Fragmentation as a Predictor of Live Birth Rate
Time frame: up to 36 months
The odds ratio on live birth per unit increase in % total Sperm DNA Fragmentation of the diagnostic sample.
6 secondary outcomes
% SDF 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)
Time frame: up to 3 months
% SDF in the Total Fraction in the Ejaculate of the IUI- Sample
Time frame: 36 months
% SDF in the Vital Fraction in the Ejaculate of the IUI- Sample
Time frame: 36 months
% SDF 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
Time frame: 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 36675960Sugihara 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.
Related trials for Infertility Unexplained
Recruiting
Sperm Preparation Prior to Intrauterine Insemination Study
Infertility, Infertility Secondary
Recruiting
Hormone-free Antral Retrieval for Viable Embryo Storage & Transfer
Infertility
Active, not recruitingPhase 3
FRIEND: Fibroids and Unexplained Infertility Treatment With Epigallocatechin Gallate; A Natural CompounD in Green Tea
Leiomyoma, Uterine
Recruiting
Royal Jelly Supplementation in Unexplained Male Infertility
Unexplained Infertility, Male Infertility
Not yet recruitingObservational study
ERA in Young Primary Infertile RIF Patients
Recurrent Implantation Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessa N Sugihara, MD principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DNA fragmentation by TUNEL assay in people with Infertility Unexplained and Infertility, Male, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DNA Fragmentation as a Predictor of Live Birth Rate (time frame: up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03319654, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.