Impact of Telomere Biology and Sperm DNA Fragmentation on Embryonic Development

NCT ID: NCT05508217

Last Updated: 2024-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

204 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-22

Study Completion Date

2024-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sperm DNA Fragmentation Male Fertility Telomeres Sperm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

IVI Madrid

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Carlos Balmori Boticario, PhD

Role: PRINCIPAL_INVESTIGATOR

IVI Madrid

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ivirma Madrid

Madrid, , Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Carlos Balmori Boticario, PhD

Role: CONTACT

+34 180 29 00

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

CARLOS BALMORI, PhD

Role: primary

91 180 29 00

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2202-MAD-024-CB

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.