An observational study in Sperm DNA Fragmentation, Male Fertility and Telomeres, sponsored by IVI Madrid. Recruiting at 1 site in Spain. Open to male participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-11.
Sponsored by IVI Madrid · Observational
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.
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.
IVI Madrid is the lead sponsor of 35 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
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.
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.
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: 1. Determination of the TL by means of two methods: Q-FISH and PCR.
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.
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: 2. Determination of sperm DNA fragmentation by tunnel technique.
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.
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: 3. Assess sperm maturation.
Time frame: 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.
Time frame: 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
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.
To know the important of telomere length and DNA fragmentation levels for sucessful treatment
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.
To know the male characteristics that influence the treatment
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.
To know the male characteristics that influence the treatment
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2022 (actual). Primary completion is estimated for Oct 2024, 25 months after the start.
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