Clinical trial NCT05508217: Impact of Telomere Biology and Sperm DNA Fragmentation on Embryonic Development
Official title: Impact of Telomere Biology and Sperm DNA Fragmentation on Embryonic Development
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sperm DNA Fragmentation
Male Fertility
Telomeres
Sperm
Keywords: Sperm DNA fragmentation
Telomeres
Sperm
Male fertility
Sperm telomeric length
Lead sponsor: IVI Madrid
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 204
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
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.
timeFrame: 6 months
Secondary outcomes:
measure: 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.
timeFrame: 6 months
measure: 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.
timeFrame: 6 months
measure: 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.
timeFrame: 6 months
measure: Percentage of short telomeres in samples analysed by FISH will be establish.
timeFrame: 6 months
measure: To determine the sperm DNA fragmentation measured by Tunel assay and its correlation with the rate of blastocyst development.
timeFrame: 6 months
measure: Correlation of telomere length data with sperm DNA fragmentation levels, as well as fertilization, implantation, blastocyst development and pregnancy rate and live-birth.
timeFrame: 6 months
measure: To assess if there is a correlation between embryo morphokinetic parameters and telomere length, levels of sperm DNA fragmentation, BMI and paternal age.
timeFrame: 6 months
measure: 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.
timeFrame: 6 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Ivirma Madrid
Study officials:
affiliation: IVI Madrid
name: Carlos Balmori Boticario, PhD
role: PRINCIPAL_INVESTIGATOR
References: