Impact of Telomere Biology and Sperm DNA Fragmentation on Embryonic Development

Study Overview
=================
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.

Official Title
-----------------
Impact of Telomere Biology and Sperm DNA Fragmentation on Embryonic Development

Conditions
-----------------
Sperm DNA Fragmentation, Male Fertility, Telomeres, Sperm

Participation Criteria
=================
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.
Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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 | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sperm DNA fragmentation, Telomeres, Sperm, Male fertility, Sperm telomeric length