Impact of Telomere Biology and Sperm DNA Fragmentation on Embryonic Development

Sperm Clinical Trial

Official title:

Impact of Telomere Biology and Sperm DNA Fragmentation on Embryonic Development

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05508217
• Other study ID #: 2202-MAD-024-CB
• Status: Recruiting
• Start date: August 22, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: January 2024
• Source: IVI Madrid
• Contact: Carlos Balmori Boticario, PhD
• Phone: +34 180 29 00
• Email: Carlos.Balmori[@]ivirma.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 204
• Est. completion date: December 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Male Fertility
• Sperm
• Sperm DNA Fragmentation
• Telomeres

Locations

Country	Name	City	State
Spain	Ivirma Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
IVI Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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