NCT05508217

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
204

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

August 22, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 11, 2024

Status Verified

January 1, 2024

Enrollment Period

2.1 years

First QC Date

August 16, 2022

Last Update Submit

January 10, 2024

Conditions

Sperm DNA FragmentationMale FertilityTelomeresSperm

Keywords

Sperm DNA fragmentationTelomeresSpermMale fertilitySperm telomeric length

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • 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

  • 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

  • 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

  • Percentage of short telomeres in samples analysed by FISH will be establish.

    6 months

  • To determine the sperm DNA fragmentation measured by Tunel assay and its correlation with the rate of blastocyst development.

    6 months

  • +3 more secondary outcomes

Eligibility Criteria

Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMen 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.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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.

You may not qualify if:

  • Males with any known chronic disease or genetic alteration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ivirma Madrid

Madrid, 28023, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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 Officials

  • Carlos Balmori Boticario, PhD

    IVI Madrid

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos Balmori Boticario, PhD

CONTACT

+34 180 29 00Carlos.Balmori@ivirma.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 19, 2022

Study Start

August 22, 2022

Primary Completion

October 1, 2024

Study Completion

December 1, 2024

Last Updated

January 11, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)