Impact of Telomere Biology and Sperm DNA Fragmentation on Embryonic Development

January 10, 2024 updated by: IVI Madrid

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

204

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Madrid, Spain, 28023
        • Recruiting
        • Ivirma Madrid
        • Contact:
          • CARLOS BALMORI, PhD
          • Phone Number: 91 180 29 00

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Translated with www.DeepL.com/Translator (free version)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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.
Time Frame: 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.
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.
Time Frame: 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:

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.
Time Frame: 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:

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.
Time Frame: 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.
6 months
Percentage of short telomeres in samples analysed by FISH will be establish.
Time Frame: 6 months
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.
Time Frame: 6 months
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.
Time Frame: 6 months
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.
Time Frame: 6 months
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.
Time Frame: 6 months
To know the male characteristics that influence the treatment
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IVI Madrid

Investigators

  • Principal Investigator: Carlos Balmori Boticario, PhD, IVI Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2022

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 16, 2022

First Submitted That Met QC Criteria

August 18, 2022

First Posted (Actual)

August 19, 2022

Study Record Updates

Last Update Posted (Estimated)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2202-MAD-024-CB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sperm

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe