Sperm DNA FragmentationNCT05508217
Impact of Telomere Biology and Sperm DNA Fragmentation on Embryonic Development
An observational study of Sperm DNA Fragmentation and Male Fertility, run by IVI Madrid at 1 site in Spain.
Trial summary
The proposed project we intend to assess the implication of the telomeric pathway in male infertility. To get this, several analyzes will be carried out: 1. Determination of the TL by means of two methods: Q-FISH and PCR. 2. Determination of sperm DNA fragmentation by tunnel technique. 3. Assess sperm maturation. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sperm DNA Fragmentation, Male Fertility, Telomeres
- How many people
- 204 participants
- Where
- 1 siteSpain
- Study dates
- 22 Aug 2022to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The target population is men with normozoospermia attending the IVI Madrid clinic. Men with oligoasthenozoospermic subfertility will also be taken in order to compare data with more extreme situations. However, the results of the study (a possible telomeric length and DNA fragmentation analysis kit) are intended to be applied to normozoospermic men whose infertility is classified as idiopathic, i.e. despite normal laboratory results, no cause for their reproductive problem can be found. Translated with www.DeepL.com/Translator (free version)
Who may be able to join
- Men of any age who come to IVI Madrid in the context of a couple's infertility study and who present normozoospermia or semenograms with sperm count >10mill/ml, >25% progressive motility and > 1% normal morphology.
Who cannot join
- Males who have suffered any acute illness in the three months prior to inclusion in the study.
- Males with any known chronic disease or genetic alteration.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Ivirma Madrid
Madrid, 28023
CARLOS BALMORI, PhD, 91 180 29 00
About this study
The proposed project we intend to assess the implication of the telomeric pathway in male infertility. To get this, several analyzes will be carried out: 1. Determination of the TL by means of two methods: Q-FISH and PCR. 2. Determination of sperm DNA fragmentation by tunnel technique. 3. Assess sperm maturation.
Finally, the correlations between age, normality or not of the seminogram, LT, Short telomers (ST) accumulation, DNA fragmentation levels, sperm maturation and fertility, blastocyst development, and pregnancy rates will be established in search of cut-off points that can give a forecast of man´s fertility who consults on this subject.
Read the detailed description
To carry out the project, men who come to the clinic in the context of a couple fertility study and who do not have a known cause that justifies their infertility will be recruited. A clinical history will be made, and an informed consent will be given to them for their participation in the project (Annex Consents). Semen samples will be obtained on the day of oocyte fertilization and the unused part of the sample is recovered for Sperm LT determination, ST accumulation, sperm DNA fragmentation and sperm maturation.
- Conditions
- Sperm DNA Fragmentation, Male Fertility, Telomeres, Sperm
- Keywords
- Sperm DNA fragmentation, Telomeres, Sperm, Male fertility, Sperm telomeric length
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the correlation between the length of the telomeres of the spermatozoa used in ICSI treatments with donor oocytes and their rate of blastocyst development.
Characterisation of telomeric factors (telomere length, percentage of short telomeres, DNA damage) in men undergoing fertility treatments using donor oocytes, in order to find out whether telomeric parameters can be a predictive factor for fertility.
Measured: 6 months
Secondary outcomes (8)
Methods of telomere measurement PCR and Q-FISH will be evaluated in order to assess whether the results are superimposable and to determine their advantages and disadvantages.
With the proposed project we intend to assess the implication of the telomeric pathway in male infertility. To get this, several analyzes will be carried out:
- Determination of the TL by means of two methods: Q-FISH and PCR.
Measured: 6 months
Methods of telomere measurement PCR and Q-FISH will be evaluated in order to assess whether the results are superimposable and to determine their advantages and disadvantages.
With the proposed project we intend to assess the implication of the telomeric pathway in male infertility. To get this, several analyzes will be carried out:
- Determination of sperm DNA fragmentation by tunnel technique.
Measured: 6 months
Methods of telomere measurement PCR and Q-FISH will be evaluated in order to assess whether the results are superimposable and to determine their advantages and disadvantages.
With the proposed project we intend to assess the implication of the telomeric pathway in male infertility. To get this, several analyzes will be carried out:
- Assess sperm maturation.
Measured: 6 months
Percentage of short telomeres in samples analysed by FISH will be establish.
To establish the percentage de short telomeres in the samples to know a new biomark.
Measured: 6 months
To determine the sperm DNA fragmentation measured by Tunel assay and its correlation with the rate of blastocyst development.
To establish the relationship of DNA fragmentation and the blastocyst development
Measured: 6 months
Correlation of telomere length data with sperm DNA fragmentation levels, as well as fertilization, implantation, blastocyst development and pregnancy rate and live-birth.
To know the important of telomere length and DNA fragmentation levels for sucessful treatment
Measured: 6 months
To assess if there is a correlation between embryo morphokinetic parameters and telomere length, levels of sperm DNA fragmentation, BMI and paternal age.
To know the male characteristics that influence the treatment
Measured: 6 months
Establish an algorithm on the degree of male fertility based on different combinations with the previously collected data: telomere length, sperm DNA fragmentation, fertilization rates, blastocyst formation rate, pregnancy and live newborn.
To know the male characteristics that influence the treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start22 Aug 2022
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sperm DNA FragmentationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IVI Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Balmori Boticario, PhD, Principal investigator, IVI Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508217
- Sponsor's protocol ID
- 2202-MAD-024-CB
- Status last verified
- Jan 2024
- First submitted
- 16 Aug 2022
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Telomere Biology and Sperm DNA Fragmentation on Embryonic Development
- ClinicalTrials.gov ID
- NCT05508217
- Acronym / sponsor ID
- 2202-MAD-024-CB
- Conditions
- Sperm DNA Fragmentation, Male Fertility, Telomeres, Sperm
- Keywords
- Sperm DNA fragmentation, Telomeres, Sperm, Male fertility, Sperm telomeric length
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- IVI MadridUniversity, hospital or other
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed project we intend to assess the implication of the telomeric pathway in male infertility. To get this, several analyzes will be carried out: 1. Determination of the TL by means of two methods: Q-FISH and PCR. 2. Determination of sperm DNA fragmentation by tunnel technique. 3. Assess sperm maturation.
Finally, the correlations between age, normality or not of the seminogram, LT, Short telomers (ST) accumulation, DNA fragmentation levels, sperm maturation and fertility, blastocyst development, and pregnancy rates will be established in search of cut-off points that can give a forecast of man´s fertility who consults on this subject.
Detailed description
To carry out the project, men who come to the clinic in the context of a couple fertility study and who do not have a known cause that justifies their infertility will be recruited. A clinical history will be made, and an informed consent will be given to them for their participation in the project (Annex Consents). Semen samples will be obtained on the day of oocyte fertilization and the unused part of the sample is recovered for Sperm LT determination, ST accumulation, sperm DNA fragmentation and sperm maturation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The target population is men with normozoospermia attending the IVI Madrid clinic. Men with oligoasthenozoospermic subfertility will also be taken in order to compare data with more extreme situations. However, the results of the study (a possible telomeric length and DNA fragmentation analysis kit) are intended to be applied to normozoospermic men whose infertility is classified as idiopathic, i.e. despite normal laboratory results, no cause for their reproductive problem can be found. Translated with www.DeepL.com/Translator (free version)
Key inclusion criteria (1 listed)
- Men of any age who come to IVI Madrid in the context of a couple's infertility study and who present normozoospermia or semenograms with sperm count >10mill/ml, >25% progressive motility and > 1% normal morphology.
Key exclusion criteria (2 listed)
- Males who have suffered any acute illness in the three months prior to inclusion in the study.
- Males with any known chronic disease or genetic alteration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the correlation between the length of the telomeres of the spermatozoa used in ICSI treatments with donor oocytes and their rate of blastocyst development.
Time frame: 6 months
Characterisation of telomeric factors (telomere length, percentage of short telomeres, DNA damage) in men undergoing fertility treatments using donor oocytes, in order to find out whether telomeric parameters can be a predictive factor for fertility.
8 secondary outcomes
Methods of telomere measurement PCR and Q-FISH will be evaluated in order to assess whether the results are superimposable and to determine their advantages and disadvantages.
Time frame: 6 months
Methods of telomere measurement PCR and Q-FISH will be evaluated in order to assess whether the results are superimposable and to determine their advantages and disadvantages.
Time frame: 6 months
Methods of telomere measurement PCR and Q-FISH will be evaluated in order to assess whether the results are superimposable and to determine their advantages and disadvantages.
Time frame: 6 months
Percentage of short telomeres in samples analysed by FISH will be establish.
Time frame: 6 months
To determine the sperm DNA fragmentation measured by Tunel assay and its correlation with the rate of blastocyst development.
Time frame: 6 months
Correlation of telomere length data with sperm DNA fragmentation levels, as well as fertilization, implantation, blastocyst development and pregnancy rate and live-birth.
Time frame: 6 months
To assess if there is a correlation between embryo morphokinetic parameters and telomere length, levels of sperm DNA fragmentation, BMI and paternal age.
Time frame: 6 months
Establish an algorithm on the degree of male fertility based on different combinations with the previously collected data: telomere length, sperm DNA fragmentation, fertilization rates, blastocyst formation rate, pregnancy and live newborn.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Sperm DNA Fragmentation
Recruiting
Comparison of Two Different Sperm Processing Methods and Their Effects on Sperm DNA Fragmentation and Embryo Development
DNA Damage, DNA Strand Breaks
Not yet recruiting
Randomized Non-inferiority Within-Patient Trial of Density Gradient Processing of Sequential Ejaculates Versus Centrifugation-free Sperm Separation Device for ICSI in Men With Elevated Sperm DNA Fragmentation.
Male
Active, not recruitingObservational study
Sperm Selection Strategies and Male-Factor Phenotypes in ICSI
Assisted Reproductive Technology, Assisted Reproductive Technology Outcomes
Not yet recruiting
Nordic Sperm DNA Study
Male Infertility, Sperm DNA Fragmentation
Recruiting
Effectiveness of Live Motile Sperm Sorting Device on IVF Outcomes in Advanced Paternal Age
Male Infertility, Advanced Paternal Age
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.
Carlos Balmori Boticario, PhD principal investigator
IVI Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sperm DNA Fragmentation and Male Fertility, run by IVI Madrid at 1 site in Spain.
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 2 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: status not confirmed, as of the sponsor's last update on 11 Jan 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos Balmori Boticario, PhD (+34 180 29 00, Carlos.Balmori@ivirma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the correlation between the length of the telomeres of the spermatozoa used in ICSI treatments with donor oocytes and their rate of blastocyst development. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2024.