Impact of Telomere Biology and Sperm DNA Fragmentation on Embryonic Development

Recruiting

• Conditions: Sperm DNA Fragmentation; Telomeres; Sperm; Male Fertility

• Registration Number: NCT05508217
• Lead Sponsor: IVI Madrid

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.

Study Timeline

• Study First Submitted: 2022-08-16
• Study First Submitted QC: 2022-08-18
• Study First Posted: 2022-08-19
• Study Start: 2022-08-22
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-11
• Primary Completion: 2024-10-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 204

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of short telomeres in samples analysed by FISH will be establish.	6 months	To establish the percentage de short telomeres in the samples to know a new biomark.
To assess if there is a correlation between embryo morphokinetic parameters and telomere length, levels of sperm DNA fragmentation, BMI and paternal age.	6 months	To know the male characteristics that influence the treatment
To determine the sperm DNA fragmentation measured by Tunel assay and its correlation with the rate of blastocyst development.	6 months	To establish the relationship of DNA fragmentation and the blastocyst development
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.	6 months	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.
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.	6 months	To know the male characteristics that influence the treatment
Correlation of telomere length data with sperm DNA fragmentation levels, as well as fertilization, implantation, blastocyst development and pregnancy rate and live-birth.	6 months	To know the important of telomere length and DNA fragmentation levels for sucessful treatment

Trial Locations

Locations (1)

Ivirma Madrid; 🇪🇸 Madrid, Spain